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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/NCT00957086




Registration number
NCT00957086
Ethics application status
Date submitted
11/08/2009
Date registered
12/08/2009
Date last updated
9/01/2024

Titles & IDs
Public title
Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer
Scientific title
Phase III, Double-Blind, Placebo-Controlled Study of Post-Operative Adjuvant Concurrent Chemo-Radiotherapy With or Without Nimotuzumab for Stage III/IV Head & Neck Squamous Cell Cancer
Secondary ID [1] 0 0
IHN01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Squamous Cell of Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nimotuzumab
Treatment: Drugs - Placebo

Active Comparator: Nimotuzumab - Comprising Adjuvant Cisplatin, Concurrent RT and Nimotuzumab

Placebo Comparator: Placebo - Comprising Adjuvant Cisplatin, Concurrent RT and Placebo


Treatment: Drugs: Nimotuzumab
Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.

Treatment: Drugs: Placebo
Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the disease-free survival between patients randomized to adjuvant nimotuzumab/cisplatin/RT with the control arm
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
To compare the overall survival between the two arms
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
To assess the Toxicity Profile between the 2 arms
Timepoint [2] 0 0
5 years

Eligibility
Key inclusion criteria
- Age should be greater than or equal to the minimum age of consent in the applicable
country

- Histologically proven head and neck squamous cell cancer (excluding nasopharynx,
salivary glands, paranasal sinuses and unknown primaries) on biopsy of the primary
lesion or the neck mass.

- Resectable stage III/IV according to the AJCC/UICC staging system with no evidence of
distant metastasis.

- Complete macroscopic resection.

- Patients should have at least one of the following pathological features for
inclusion: pT3 or pT4 and any nodal stage (N), except T3N0 of the larynx, with
negative resection margins, or a tumor stage of 1 or 2 with a nodal stage of 2 or 3
and no distant metastasis (M0); patients with stage T1 or T2 and N0 or N1 who had
unfavorable pathological findings (extranodal spread, positive resection margins,
perineural involvement, or vascular tumor embolism) are also eligible, as are those
with oral-cavity or oropharyngeal tumors with involved lymph nodes at level IV or V.

- Performance status must be ECOG 0 or 1. Patients should be able to tolerate
chemotherapy and radiotherapy.

- Adequate bone marrow, renal and hepatic function:

1. WBC>3000/mm3, platelets>100000/mm3

2. Serum creatinine<upper limit of normal range as per institution and calculated
creatinine clearance (according to the Cockcroft and Gault method) >50 ml/min.

3. SAP, SGOT<2 x upper limit of normal range, bilirubin <1.5 x upper limit of normal
range.

- Written informed consent.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Histology other than SCC or its subtype.

- Patients with disease subsite deemed suitable for organ preservation approach, namely
stage III/IV laryngeal or hypopharyngeal carcinoma with not more than low-volume T4
disease; low-volume T4 disease is defined as disease not eroding into cartilage or
extending not more than 1 cm into the base of tongue.

- Clinical or radiological evidence of distant metastasis.

- Uncontrolled comorbidities such as diabetes mellitis, hypertension, cardiac disease.

- Uncontrolled infection.

- Uncontrolled hypercalcemia.

- Prior history of cancer less than 5 years ago or a synchronous primary outside the
head and neck area.

- Prior treatment, head and neck radiotherapy, chemotherapy or surgery (excluding
biopsy) or anti-EGFR therapy such as cetuximab/EGFR oral tyrosine kinase inhibitor.

- Patients for whom compliance with follow-up is unlikely.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
710
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
VIC 3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Cuba
State/province [1] 0 0
Vedado
Country [2] 0 0
Egypt
State/province [2] 0 0
Alexandria
Country [3] 0 0
Egypt
State/province [3] 0 0
Cairo
Country [4] 0 0
India
State/province [4] 0 0
Bangalore
Country [5] 0 0
India
State/province [5] 0 0
Kerala
Country [6] 0 0
India
State/province [6] 0 0
Mumbai
Country [7] 0 0
India
State/province [7] 0 0
Tamil Nadu
Country [8] 0 0
India
State/province [8] 0 0
Trivandrum
Country [9] 0 0
Indonesia
State/province [9] 0 0
Jakarta
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Gyeonggi-do
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Incheon
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Malaysia
State/province [13] 0 0
Kuala Lumpur
Country [14] 0 0
Malaysia
State/province [14] 0 0
Melaka
Country [15] 0 0
Philippines
State/province [15] 0 0
Manila
Country [16] 0 0
Philippines
State/province [16] 0 0
Quezon City
Country [17] 0 0
Saudi Arabia
State/province [17] 0 0
Riyadh
Country [18] 0 0
Singapore
State/province [18] 0 0
Singapore
Country [19] 0 0
South Africa
State/province [19] 0 0
Durban
Country [20] 0 0
South Africa
State/province [20] 0 0
Panorama
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
Thailand
State/province [23] 0 0
Bangkok
Country [24] 0 0
Thailand
State/province [24] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Other
Name
National Cancer Centre, Singapore
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Medical Research Council (NMRC), Singapore
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Innogene Kalbiotech Pte. Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to improve the loco-regional control rate and overall survival of
locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that
the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both
epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold
standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after
resection of their locally advanced HNSCC will confer therapeutic advantage.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00957086
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
K C Soo, Prof
Address 0 0
National Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00957086