- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193882
Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prospective radical treatment trials in oesophageal cancer have shown responses in both radiotherapy alone and radiotherapy when combined with chemotherapy. Retrospective studies show a response in the palliative setting to relieve dysphagia. The response, durability and quality of life end points have not been previously fully documented. This will be addressed by this trial.
Dysphagia is the commonest presenting symptom due to local disease obstructing the oesophagus. Difficulty eating not only affects the patient's ability to maintain nutrition, but also impacts on all areas of quality of life. Relief of dysphagia becomes the highest priority for treatment.
At the time of developing this protocol there were no randomised trials comparing chemo-radiotherapy and radiotherapy in the palliative setting.
Few studies have prospectively assessed quality of life data for patients with oesophageal cancer, and although toxicity and survival data is available, there is no long-term data on quality of life. This trial will assess quality of life in a consecutive manner using a standardised self-reporting measure of quality of life, and compare quality of life across two groups having different treatments.
Eligible patients are those with proven carcinoma of the oesophagus who are deemed not suitable for definitive radical treatment due to the advanced nature of disease, presence of metastases or intercurrent illness, who have symptomatic dysphagia requiring loco-regional palliation.
Patients will be randomised to the following treatment options:
Radiotherapy Alone
- 35 Gy in 15 fractions (Australia and New Zealand) or
- 30 Gy in 10 fractions(Canada ONLY)
Chemo-Radiotherapy
- 35 Gy in 15 fractions (Australia and New Zealand) or
- 30 Gy in 10 fractions (Canada ONLY)
- Cisplatin 80mg/m2 IV day 1 (or 20mg/m2/day IV days 1 - 4)
- 5-Fluorouracil 800mg/m2/day IV days 1 - 4
Patients will have an initial baseline assessment then be followed up weekly during treatment, monthly for 1 year post treatment and then 3 monthly.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Liverpool, New South Wales, Australia, 1871
- Liverpool Hospital
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Randwick, New South Wales, Australia, 2031
- Prince of Wales Hospital
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Sydney, New South Wales, Australia, 2069
- Royal North Shore Hospital
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Queensland
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Auchenflower, Queensland, Australia, 4006
- Premion - Wesley
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Herston, Queensland, Australia, 4029
- Royal Brisbane Hospital
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South Brisbane, Queensland, Australia, 4101
- Radiation Oncology - Mater Centre
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Townsville, Queensland, Australia, 4810
- North Queensland Oncology Service
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Tasmania
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Launceston, Tasmania, Australia, 7250
- Launceston General Hospital
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Victoria
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Box Hill, Victoria, Australia, 3128
- Peter MacCallum - Box Hill Hospital
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Geelong, Victoria, Australia, 3220
- Andrew Love Cancer Care Centre, Geelong Hospital
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Melbourne, Victoria, Australia, 8006
- Peter MacCallum Cancer Centre
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east Bentleigh, Victoria, Australia, 3165
- Peter MacCallum - Moorrabbin
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Western Australia
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Perth, Western Australia, Australia, 6001
- Royal Perth Hospital
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Quebec, Canada, G1R 2J6
- Hotel-Dieu de Quebec
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- Cancer Care Manitoba Winnipeg
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital - Atlantic Health Sci
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Kingston, Ontario, Canada, K7L 5P9
- Cancer Centre of Southeastern Ontario Kingston
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Kitchener, Ontario, Canada, N2G 1G3
- Grand River Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Christchurch, New Zealand, 4710
- Christchurch Hospital
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Hull, United Kingdom
- Princess Royal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A: Radiotherapy
Radiotherapy alone
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35 Gy in 15 fractions
Other Names:
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Experimental: B: Chemo-radiotherapy
Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
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35 Gy in 15 fractions
Other Names:
80mg/m2 IV day 1
Other Names:
800mg/m2/day IV days 1 - 4
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relief of dysphagia
Time Frame: This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
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This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dysphagia progression free survival.
Time Frame: This will be measured from randomisation to the time of first progression of dysphagia.
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This will be measured from randomisation to the time of first progression of dysphagia.
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Quality of Life differences post treatment and at 3 months and 6 months.
Time Frame: post treatment and at 3 months and 6 months.
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post treatment and at 3 months and 6 months.
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Acute and late toxicity.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Survival.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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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.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Number of patients receiving secondary treatment (radiation, chemotherapy or stenting).
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Time to achieving a complete response i.e. dysphagia score of 0.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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Collaborators and Investigators
Investigators
- Study Chair: Michael Penniment, FRANZCR, Royal Adelaide Hopsital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Deglutition Disorders
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cisplatin
- Fluorouracil
Other Study ID Numbers
- TROG 03.01
- NCIC CTG ES.2 (Other Identifier: National Cancer Institute of Canada Clinical Trials Group)
- TGA 2004/83 (Other Identifier: Theraputic Goods of Australia)
- NHMRC 291103 (Other Identifier: National Health and Medical Research Council)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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