Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.

• Status: Completed
• Trial end date: 2013-06-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborators: Canadian Cancer Trials Group; National Health and Medical Research Council, Australia; NCIC Clinical Trials Group
• Treatments: Cisplatin; Fluorouracil

Criteria

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