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RECRUITING
NCT07528495
PHASE2/PHASE3

A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's

Sponsor: All India Institute of Medical Sciences

View on ClinicalTrials.gov

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

Interventions

RADIATION

IMRT - adjuvant concurrent CRT/ RT

IMRT - adjuvant concurrent CRT/ RT as 66Gy/60 Gy in 33/30 fractions to primary and regional lymphatics

RADIATION

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

DRUG

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