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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01179074
Other study ID # SEMSRT-1
Secondary ID
Status Completed
Phase N/A
First received May 25, 2010
Last updated August 10, 2010
Start date April 2007
Est. completion date March 2009

Study information

Verified date February 2010
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial Summary

To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
oesophageal stenting with self expandable metal stent
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
Oesophageal stent followed by external beam radiotherapy
30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group

Locations

Country Name City State
India Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

References & Publications (1)

Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relief of dysphagia 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
1 week after intervention No
Primary Relief of dysphagia Dysphagia grades at 3 months will be assessed in the two groups 3 months following intervention No
Primary Relief of dysphagia Dysphagia grades at 5 months will be assessed in the two groups 5 months after intervention No
Secondary Survival 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 From the date of diagnosis till death No
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