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A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
Sponsor: All India Institute of Medical Sciences
Summary
The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.
Official title: The Eliminate Trial: A Phase II/III Randomised Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's in pN0/N1 Neck for Oral Cavity Carcinomas
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
396
Start Date
2024-04-03
Completion Date
2028-04-03
Last Updated
2026-04-14
Healthy Volunteers
Yes
Conditions
Interventions
IMRT - adjuvant concurrent CRT/ RT
IMRT - adjuvant concurrent CRT/ RT as 66Gy/60 Gy in 33/30 fractions to primary and regional lymphatics
ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics
IMRT- adjuvant concurrent CRT/ RT as 66Gy/60 Gy in 33/30 fractions/ Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only \- elimination of regional lymphatics
Cisplatin
Cisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease.
Locations (1)
Nci, Aiims
Jhajjar, Haryana, India