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

Palliative stenting with radiotherapy versus stenting with chemoradiotherapy for inoperable oesophageal carcinoma : a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004534
Enrollment
60
Registered
2014-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Radiotherapy and chemotherapy: Radiotherapy dose of 30 GY along with oral capecitabine for 12 days and cisplatin infusion on Day 1 to 3 and Day 10 to 12 will be given after endoscopi

Sponsors

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
i) To compare relief of dysphagia and quality of life (QOL) in patients with inoperable oesophageal cancer treated with stenting followed by radiotherapy versus those treated with stenting followed by chemoradiotherapyTimepoint: to measure QOL every two months till death

Secondary

MeasureTime frame
i) To assess overall survival (OS) benefit of chemoradiotherapy following stenting versus radiotherapy following stenting in these patients. ii) To assess treatment related complications between the two treated groups Timepoint: to find the overall survival benfit and treatment complications at the end of the study

Countries

India

Contacts

Public ContactDr v arun kumar

AIIMS

peush_sahni@hotmail.com9999646488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026