Role of Radiotherapy Following Oesophageal Stenting in Cancer

• Relief of dysphagia [ Time Frame: 1 week after intervention ] [ Designated as safety issue: No ]

  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

• Relief of dysphagia [ Time Frame: 3 months following intervention ] [ Designated as safety issue: No ]
  Dysphagia grades at 3 months will be assessed in the two groups
• Relief of dysphagia [ Time Frame: 5 months after intervention ] [ Designated as safety issue: No ]
  Dysphagia grades at 5 months will be assessed in the two groups

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

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.

• Procedure: oesophageal stenting with self expandable metal stent
  oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
  Other Name: Ultraflex stent, Microvasive, Boston Scientific
• Procedure: Oesophageal stent followed by external beam radiotherapy
  30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group
  Other Name: External beam radiotherapy

• Active Comparator: Oesophageal stent alone
  Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents
  Intervention: Procedure: oesophageal stenting with self expandable metal stent
• Active Comparator: Oesophageal stent followed by EBRT
  Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks)
  Interventions:

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

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