Status:
COMPLETED
Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Canadian Cancer Trials Group
Conditions:
Esophagus Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 chemothe...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00193882
Start Date
July 7 2003
End Date
June 18 2013
Last Update
July 12 2017
Active Locations (25)
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1
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
2
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
3
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2069
4
Premion - Wesley
Auchenflower, Queensland, Australia, 4006