Advanced oesophageal cancer study to compare quality of life and palliation of dysphagia

Phase 3

Completed

• Conditions: Advanced oesophagus cancer, not suitable for radical treatment.; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12606000526572
• Lead Sponsor: Trans Tasman Radiation Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Biopsy proven carcinoma of the Oesophagus
2. 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).
3. Symptomatic patients with dysphagia scores of => 1 i.e. able to eat only some sollids (see appendix 1)
4. Performance status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
5. Patients msut begin treatment within 2 weeks of randomisation
6. Patient is at least 18 years old
7. Adequate haematology function to undergo chemotherapy Peripheral blood - Neutrophils > 1.5 x 109/L - Platelets > 100 x 109/L
8. Adequate renal function, Creatine - Calculated clearence 50 ml/min (see appendix 1).
9. Patients capable of child bearing are using adequate contraception.
10. Written informed consent of patient.

Exclusion Criteria

1. Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest.
2. Synchronous active malignancies.
3. Pregnant or lactating patients.
4. Patients unfit for any treatment component.
5. Tracheo-oesophageal fistula.
6. Stents in situ.
7. Previous chemotherapy for Oesophageal Cancer
8. CT scan of thorax and abdomen more than 8 weeks prior to randomisation
9. Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief of dysphagia. Defined as improvment of at least one point on the Mellow scale. [This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.]