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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01855451
Registration number
NCT01855451
Ethics application status
Date submitted
13/05/2013
Date registered
16/05/2013
Date last updated
18/11/2022
Titles & IDs
Public title
Weekly Cetuximab/RT Versus Weekly Cisplatin/RT in HPV-Associated Oropharyngeal Squamous Cell Carcinoma
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Scientific title
TROG12.01 A Randomised Trial of Weekly Cetuximab and Radiation Versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma
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Secondary ID [1]
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ACTRN12613000279729
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Secondary ID [2]
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TROG 12.01
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Universal Trial Number (UTN)
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Trial acronym
HPVOropharynx
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HPV Positive Oropharyngeal Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Other - RT (70 Gy in 35 fractions)
Treatment: Drugs - Cisplatin
Active Comparator: Radiation Therapy + Cetuximab - RT (70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly Cetuximab (400 mg/m2 loading dose IV prior to radiation, followed by weekly cetuximab 250 mg/m2 for the duration of the radiotherapy)
Active Comparator: Radiation Therapy + Cisplatin - RT(70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly Cisplatin (40 mg/m2 IV for the duration of the radiotherapy)
Treatment: Drugs: Cetuximab
Treatment: Other: RT (70 Gy in 35 fractions)
Treatment: Drugs: Cisplatin
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Symptom Severity
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Assessment method [1]
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The area under curve of symptom severity between weekly cisplatin and Radiotherapy Therapy (RT) versus weekly cetuximab and RT from baseline to week 20 (13 weeks post-completion of radiotherapy) as measured by M.D. Anderson Symptom Inventory - Head and Neck Module (MDASI-HN).
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Timepoint [1]
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20 weeks
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Secondary outcome [1]
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Symptom severity
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Assessment method [1]
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Symptom severity measured by MDASI-HN (Symptom Interference Score, Symptom Score, Symptom Clusters and individual item scores at individual time points)and by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN).
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Interference of symptoms with daily life
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Assessment method [2]
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To compare interference of symptoms with daily life using the MDASI-HN Symptom Interference Score and Quality adjusted life years (QALYs) using the EQ-5D-5L
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Timepoint [2]
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24 mths
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Secondary outcome [3]
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Psychological distress
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Assessment method [3]
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To compare psychological distress measured by FACT-HN domain scores and depression and anxiety scales of Hospital Anxiety and Depression Scale (HADS)
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Timepoint [3]
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36 months
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Secondary outcome [4]
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Impact on Health Related Quality of Life
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Assessment method [4]
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Timepoint [4]
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36 months
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Secondary outcome [5]
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Swallowing dysfunction
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Assessment method [5]
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To compare swallowing dysfunction by Functional swallowing outcome (video fluoroscopy), CTCAE (v4.0) dysphagia, MDASI and FACT questionnaires, enteral feeding rates.
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Speech and dietary function
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Assessment method [6]
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To compare speech and dietary function as measured by the Performance Status Scale for Head & Neck Cancer Patients (PSS-HN)
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Timepoint [6]
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36 months
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Secondary outcome [7]
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Clinician-assessed acute and late toxicity
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Assessment method [7]
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To compare clinician-assessed acute and late toxicity using toxicity grading (CTCAE v4.0) - reported as worst toxicity and as overall acute toxicity burden (T-score)
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Timepoint [7]
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60 months
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Secondary outcome [8]
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Rate of enteral feeding
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Assessment method [8]
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To compare rate of enteral feeding at 12 months following treatment using Barnard's exact test for the comparison of two proportions
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Hearing impairment
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Assessment method [9]
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To compare hearing impairment, as measured by total score of the Hearing Handicap Inventory for adults, screening version (HHIA-S) and audiometry (results will be evaluated according to CTCAE 3 and 4 criteria, Brock criteria, Chang criteria and SIOP Boston Ototoxicity Scale).
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Timepoint [9]
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24 months
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Secondary outcome [10]
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Time to locoregional failure
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Assessment method [10]
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To compare time to locoregional failure primarily determined by evidence of progression or recurrence clinically or radiologically
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Timepoint [10]
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36 months
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Secondary outcome [11]
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Failure-free survival
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Assessment method [11]
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To compare failure-free survival by clinical and radioloigical assessments
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Timepoint [11]
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36 months
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Secondary outcome [12]
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Overall survival
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Assessment method [12]
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To compare overall survival by clinical assessment.
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Timepoint [12]
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60 months
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Secondary outcome [13]
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Pattern of disease failure
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Assessment method [13]
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Pattern of disease failure (locoregional [recurrence at primary tumour site and/or regional nodes], distant, both) as assessed radiologically.
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Timepoint [13]
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36 months
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Secondary outcome [14]
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Complete response rate
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Assessment method [14]
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To compare FDG-PET-CT complete response rate at week 20
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Timepoint [14]
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20 weeks
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Secondary outcome [15]
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Cost of health resource utilisation
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Assessment method [15]
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To compare cost of health resource utilisation via questionnaires EQ-5D-5L and RTOG return to work questionnaire.
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Timepoint [15]
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24 months
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Secondary outcome [16]
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Work status and time to return to work
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Assessment method [16]
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To compare work status and time to return to work by RTOG questionnaire
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Timepoint [16]
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24 months
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Secondary outcome [17]
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Potential prognostic markers
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Assessment method [17]
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To correlate several potential prognostic markers (including but not limited to EGFR protein level, EGFR copy number, ERCC1, plasma hepatocyte growth factor level, and plasma IL-8) with failure-free survival, overall survival and time to locoregional failure.
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Timepoint [17]
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60 months
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Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Has provided written Informed Consent for participation in this trial
3. Histologically confirmed squamous cell carcinoma of the oropharynx with p16 positive
status confirmed locally by immunohistochemistry
4. Stage III (excluding T1-2N1) or stage IV (excluding T4, N3, and distant metastasis) if
smoking history of < /=10 pack years. If > 10 pack years nodal disease must be N0 -
N2a.
5. If an excisional biopsy has been performed, patients remain eligible for the study
provided there is clinically measurable disease prior to commencing RT. The residual
disease should still meet the stage criteria required for the trial e.g. excisional
biopsy of a node with residual T3 primary, or tonsillectomy for T1 primary with
residual > N2a nodes.
6. No prior treatment for oropharyngeal cancer
7. Adequate haematological, renal, and hepatic function as defined by,
1. Absolute neutrophil count (ANC, segs + bands) > /= 1.5 x 109/L
2. Platelet count > /= 100 x 109/L
3. Total bilirubin < /= 1.5 x upper normal limit
4. ALT < /= 2.5 x upper normal limit
5. Calculated creatinine clearance (Cockcroft-Gault formula) or isotopic GFR >
55ml/min
8. ECOG performance status score of 0-1
9. Participants capable of childbearing are using adequate contraception and intend to
continue use of contraception for at least 6 months following completion of treatment
10. Negative pregnancy test within 72 hours prior to randomisation of women who are of
childbearing potential
11. Suitable for follow-up for at least 24 months as per trial protocol.
12. Sufficient proficiency in English, cognitive capacity and willingness to complete
questionnaires
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of unknown primary of the head and neck
2. T4, N3 or distant metastases
3. Smoking history >10 pack years with N2b or c nodal status
4. Women who are pregnant or lactating.
5. Previous radiotherapy to the area to be treated (excluding superficial radiotherapy
for a cutaneous malignancy)
6. Previous cisplatin or carboplatin chemotherapy
7. Prior EGFR targeted therapy of any kind
8. Primary surgery to the affected area (excisional biopsy allowed)
9. Peripheral neuropathy > /= grade 2 (CTCAE v4.0)
10. Sensori-neural hearing impairment >= grade 2 (CTCAE v4.0, hearing impaired, not
enrolled on a monitoring program) which may be exacerbated by cisplatin (Audiometric
abnormalities without corresponding clinical deafness will not be grounds for
exclusion)
11. Tinnitus > /= grade 2 (CTCAE v4.0)
12. History of interstitial lung disease or evidence of interstitial lung disease on
pre-registration CT
13. History of myocardial infarction within 12 months prior to study entry, uncontrolled
congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia,
uncontrolled psychotic disorders, active serious infections, active peptic ulcer
disease, immunosuppression due to post-organ transplantation or use of
immunosuppressants for autoimmune disorders
14. Patients known to be HIV positive
15. Other cancer that was diagnosed:
1. more than 5 years prior to current diagnosis with (i) subsequent evidence of
disease recurrence or (ii) clinical expectation of recurrence is greater than 10%
or
2. within 5 years of the current diagnosis, with the exception of successfully
treated basal cell or squamous cell skin carcinoma, in situ melanoma, or
carcinoma in situ of the cervix
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/08/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
189
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [3]
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Liverpool Hospital - Liverpool
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Recruitment hospital [4]
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St George Hospital - St George
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Recruitment hospital [5]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment hospital [6]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [7]
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Westmead Hospital - Westmead
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Recruitment hospital [8]
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Royal Brisbane and Womens Hospital - Herston
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Recruitment hospital [9]
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Townsville Hospital - Townsville
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Recruitment hospital [10]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [11]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [12]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment hospital [13]
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Austin Hospital - Melbourne N.
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Recruitment hospital [14]
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Sir Charles Gairdner - Nedlands
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Recruitment postcode(s) [1]
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- Canberra
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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2217 - St George
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Recruitment postcode(s) [5]
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- Wagga Wagga
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Recruitment postcode(s) [6]
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- Waratah
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment postcode(s) [8]
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4006 - Herston
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Recruitment postcode(s) [9]
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4810 - Townsville
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Recruitment postcode(s) [10]
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4102 - Woolloongabba
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Recruitment postcode(s) [11]
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5042 - Bedford Park
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Recruitment postcode(s) [12]
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3002 - East Melbourne
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Recruitment postcode(s) [13]
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3084 - Melbourne N.
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Recruitment postcode(s) [14]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Palmerston
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Funding & Sponsors
Primary sponsor type
Other
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Name
Trans Tasman Radiation Oncology Group
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A standard treatment for patients with head and neck cancer is radiation given with high
doses of a chemotherapy drug called cisplatin, given every 3 weeks during the radiation. This
treatment is effective but can significantly increase side effects such as difficulty with
swallowing, a sore mouth, fatigue, hearing loss, ringing in the ears and kidney failure. In
Australia, a commonly used treatment HPV-Associated Oropharyngeal Squamous Cell Carcinoma is
a lower dose of cisplatin given weekly during the radiation. The high dose and low dose
schedules result in a similar total dose of cisplatin being given during the radiation, but
it is thought that the weekly schedule results in fewer side effects while maintaining
effectiveness.
Another approach widely used around the world for patients with head and neck cancer, is to
administer the antibody, cetuximab, weekly during radiation. Cetuximab has a very different
side effect profile to cisplatin, and has been reported to result in less exacerbation of
radiation related side effects. Both cetuximab and cisplatin can reduce the growth of a
cancer and increase the effectiveness of radiation. Both cisplatin and cetuximab appear to be
effective treatments in combination with radiation, but have not been directly compared.
The purpose of this study is to compare the treatment related side effects (both acute and
longer term) between the cisplatin and cetuximab regimens. Both treatments would be given
with the same dose of radiation therapy over 7 weeks. The results of this trial will help
determine the optimal treatment for patients with HPV-Associated Oropharyngeal Squamous Cell
Carcinoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01855451
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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D Rischin, Dr
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Address
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TROG and Peter MacCallum Cancer Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01855451
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