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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/NCT00193882




Registration number
NCT00193882
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
12/07/2017

Titles & IDs
Public title
Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
Scientific title
A Randomised Phase III Study in Advanced Oesophageal Cancer to Compare Quality of Life and Palliation of Dysphagia in Patients Treated With Radiotherapy vs ChemoRadiotherapy.
Secondary ID [1] 0 0
NCIC CTG ES.2
Secondary ID [2] 0 0
TROG 03.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophagus Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Oesophageal (gullet)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cisplatin
Treatment: Other - Radiotherapy
Treatment: Drugs - 5-Fluorouracil

Active Comparator: A: Radiotherapy - Radiotherapy alone

Experimental: B: Chemo-radiotherapy - Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy


Treatment: Drugs: Cisplatin
80mg/m2 IV day 1

Treatment: Other: Radiotherapy
35 Gy in 15 fractions

Treatment: Drugs: 5-Fluorouracil
800mg/m2/day IV days 1 - 4
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relief of dysphagia
Timepoint [1] 0 0
This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
Secondary outcome [1] 0 0
Dysphagia progression free survival.
Timepoint [1] 0 0
This will be measured from randomisation to the time of first progression of dysphagia.
Secondary outcome [2] 0 0
Quality of Life differences post treatment and at 3 months and 6 months.
Timepoint [2] 0 0
post treatment and at 3 months and 6 months.
Secondary outcome [3] 0 0
Acute and late toxicity.
Timepoint [3] 0 0
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary outcome [4] 0 0
Survival.
Timepoint [4] 0 0
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary outcome [5] 0 0
Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the 5 point dysphagia scale.
Timepoint [5] 0 0
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary outcome [6] 0 0
Number of patients receiving secondary treatment (radiation, chemotherapy or stenting).
Timepoint [6] 0 0
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary outcome [7] 0 0
Time to achieving a complete response i.e. dysphagia score of 0.
Timepoint [7] 0 0
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.

Eligibility
Key inclusion criteria
- Biopsy proven Carcinoma of the oesophagus.

- Not a candidate for radical/curative treatment due to the advanced nature of the
disease, presence of metastases, or intercurrent illness. (It should be noted that,
patients with mediastinal nodes and no more distant disease maybe suitable for radical
treatment).

- Symptomatic patients with dysphagia scores of = 1 i.e. able to eat only some solids
(see Mellow Scale appendix 1)

- Performance status ECOG = 2

- Patients must begin treatment within 2 weeks of randomization.

- Patient is at least 18 years old.

- Adequate haematological function to undergo chemotherapy. Peripheral blood -
Neutrophils > 1.5 x 10^9/L - Platelets > 100 x 10^9/L

- Adequate renal function, Creatinine - Calculated clearance = 50 ml/min

- Patients capable of childbearing are using adequate contraception.

- Written informed consent of patient.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the
region of the chest.

- Synchronous active malignancies.

- Pregnant or lactating patients.

- Patients unfit for any treatment component.

- Tracheo-oesophageal fistula.

- Stents in situ.

- Previous chemotherapy for Oesophageal Cancer

- CT scan of thorax and abdomen more than 8 weeks prior to randomization

- Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more
than 2 weeks prior to randomization

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2013
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Premion - Wesley - Auchenflower
Recruitment hospital [5] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [6] 0 0
Radiation Oncology - Mater Centre - South Brisbane
Recruitment hospital [7] 0 0
North Queensland Oncology Service - Townsville
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [11] 0 0
Peter MacCallum - Box Hill Hospital - Box Hill
Recruitment hospital [12] 0 0
Peter MacCallum - Moorrabbin - east Bentleigh
Recruitment hospital [13] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2069 - Sydney
Recruitment postcode(s) [4] 0 0
4006 - Auchenflower
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4810 - Townsville
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
7250 - Launceston
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3165 - east Bentleigh
Recruitment postcode(s) [13] 0 0
3220 - Geelong
Recruitment postcode(s) [14] 0 0
8006 - Melbourne
Recruitment postcode(s) [15] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Hull

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Cancer Trials Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage
and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the
addition of chemotherapy to a short course of radiation treatment improves the proportion of
patients who achieve relief of dysphagia and improves quality of life compared to radiation
alone in patients with advanced oesophageal cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00193882
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Penniment, FRANZCR
Address 0 0
Royal Adelaide Hopsital
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/NCT00193882