MedTrace Logo

A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's

NCT07528495 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

IMRT - adjuvant concurrent CRT/ RT

IMRT - adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr to primary and regional lymphatics

RADIATION

ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics

IMRT- adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr / 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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Rishikesh

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences, Raipur

    collaborator OTHER_GOV

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2027-12-30
Completion
2028-04-03

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528495 on ClinicalTrials.gov