Role of Radiotherapy Following Oesophageal Stenting in Cancer

All India Institute Of Medical Science (AIIMS)

Status: Completed

Conditions: Oesophageal Cancer

Treatments: Procedure: Oesophageal stent followed by external beam radiotherapy; Procedure: oesophageal stenting with self expandable metal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01179074

SEMSRT-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Oesophageal stent alone

Active Comparator group

Description:

Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents

Treatment:

Procedure: oesophageal stenting with self expandable metal stent

Oesophageal stent followed by EBRT

Active Comparator group

Description:

Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks)

Treatment:

Procedure: oesophageal stenting with self expandable metal stent

Procedure: Oesophageal stent followed by external beam radiotherapy