Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial
N/A
N/A
Both
Oesophageal Cancer
Trial Information
Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Relief of dysphagia
Outcome Description:
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
Outcome Time Frame:
1 week after intervention
Safety Issue:
No
Principal Investigator
Tushar K Chattopadhyay, MS
Investigator Role:
Study Director
Investigator Affiliation:
Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi
Authority:
India: Indian Council of Medical Research
Study ID:
SEMSRT-1
NCT ID:
NCT01179074
Start Date:
April 2007
Completion Date:
March 2009
Related Keywords:
- Oesophageal Cancer
- palliation inoperable oesophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
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