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A comparison of two different treatments in advanced cancer of the esophagus(food pipe)i.e. combined chemotherapy and radiotherapy or radiotherapy alone to observe the benefit in swallowing food

Randomised comparison of palliative chemoradiotherapy with radiotherapy alone in advanced inoperable esophageal cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/06/002751
Enrollment
80
Registered
2012-06-27
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- Advanced inoperable esophageal cancer

Interventions

Intervention1: Radiotherapy,Chemotherapy: Radiotherapy- 35 Gy/15#/3 weeks, concurrent chemotherapy Cisplatin(20mg/m2 D1,2,3,17,18,19) & 5FU (750mg/m2 D1,2,3,17,18,19) Control Intervention1: Radiothera

Sponsors

Council of Scientific and Industrial ResearchCSIR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Inoperable carcinoma of esophagus b) Metastatic esophageal cancer c) Endoscopic and biopsy proven carcinoma of the esophagus d) Adenocarcinoma or squamous cell carcinoma e) Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)

Exclusion criteria

Exclusion criteria: a) Patients suitable for curative treatment with either surgery or chemo-radiation b) Lesions involving gastro-esophageal junction c) Tracheo-esophageal fistula d) Previous radiotherapy or chemotherapy e) Patient refused consent for the study f) Poor performance status (ECOG > 2) g) Pregnant and lactating patients

Design outcomes

Primary

MeasureTime frame
1)To determine dysphagia free survival in two treatment arms,2)To compare the toxicity profile between the two treatment armsTimepoint: 6 months

Secondary

MeasureTime frame
1)To assess difference of Quality of Life(QOL) between the two treatment arms,2)To determine the Overall SurvivalTimepoint: 6 months

Countries

India

Contacts

Public ContactJaspreet Kaur

All India Institute if Medical Sciences(AIIMS)

drjaspreet.ro@gmail.com9810966061

Outcome results

None listed

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