a clinical study to compare stenting with radiotherapy versus stenting with chemoradiotherapy for advanced oesophageal carcinoma patients

Phase 3

• Conditions: Health Condition 1: null- patients with inoperable oesophageal carcinoma (ECOG 1-3)

• Registration Number: CTRI/2014/04/004534
• Lead Sponsor: not applicable

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

i)Oesophageal and gastro oesophageal junction cancer patients with

•Locally advanced unresectable cancer such as invasion of tracheobronchial tree, aorta, pulmonary vascular structures.

•Metastatic disease.

•Comorbid conditions or general health status precluding a major surgical procedure with grade III and IV dysphagia.

•Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale

ii)Vocal cord palsy.

iii)Dysphagia grades 3 and 4.

iv)Biopsy proven carcinoma - both squamous cell and adenocarcinoma

Exclusion Criteria

i) Carcinoma of cervical oesophagus

ii) Patients who had already received prior radiation or chemo radiotherapy or any other modality of treatment.

iii) Patients unstable for endoscopic procedure and for radiotherapy/chemoradiotherapy due to severe co-morbid illness such as congestive heart failure, severe hepatic and renal failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified