Oesophageal Cancer
Conditions
Keywords
palliation inoperable oesophageal cancer
Brief summary
To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer
Detailed description
A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia. STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups. PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.
Interventions
PROCEDUREoesophageal stenting with self expandable metal stent
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
PROCEDUREOesophageal stent followed by external beam radiotherapy
30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc), * Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.
Exclusion criteria
* Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief of dysphagia | 1 week after intervention | Relief of dysphagia will be assessed by stratifying the ability to swallow into the following grades. Grade 1: Difficulty in swallowing solid food Grade 2: Difficulty in swallowing semisolid food Grade 3: Difficulty in swallowing liquids Grade 4: Difficulty in swallowing even saliva The dysphagia scores will be assessed 1 week after intervention (stenting and radiotherapy)in the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | From the date of diagnosis till death | Patients will be followed up at baseline, 1 week after oesophageal stenting, 1 week after completion of radiotherapy and 2 monthly thereafter till their death |
Countries
India
Outcome results
None listed