Role of Radiotherapy Following Oesophageal Stenting in Cancer

Oesophageal Cancer Clinical Trial

Official title:

Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179074
• Other study ID #: SEMSRT-1
• 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

• Esophageal Neoplasms
• Oesophageal Cancer

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