Testing High-Dose Radiotherapy to Cure Inoperable Oral Cavity Cancer : The DOSE-ROC Trial

Phase 3

Not yet recruiting

Conditions: Malignant neoplasm of overlappingsites of other and unspecified parts of mouth,

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary: This is a randomized controlled trial evaluating the efficacy of dose escalation in radiotherapy for patients with inoperable oral cavity carcinoma. Eligible patients will be randomized into two groups. The intervention arm will receive 66 Gy in 30 fractions followed by a boost of 6.6 Gy in 3 fractions using IMRT or VMAT technique along with concurrent chemotherapy. The control arm will receive standard radiotherapy of 66 Gy in 30 fractions with concurrent chemotherapy. The primary objective is to compare locoregional control at 3 months. Secondary objectives include assessment of quality of life, toxicity profiles, progression free survival, and overall survival. Patients will be followed up regularly for three years to monitor outcomes and toxicities.

Recruitment & Eligibility

Inclusion Criteria

ECOG Performance score 0, 1, 2 Patients having inoperable cancer of the oral cavity with TNM staging T1-4a N1-3b M0 and low volume T4b disease.
(inoperable would be defined as all the cases where surgery could not be done due to medical contraindications, logistic reasons, patient preference or any other reason defying surgery.).

Exclusion Criteria

Tumors with fungating mass, oro-cutaneous fistula and extensive skin involvement.
Node with fungating mass and extensive skin involvement.
Patients received radiation earlier to head and neck region.

Primary Outcome Measures

Name	Time	Method
This study is expected to increase the locoregional control in inoperable oral cavity cancers which in turn may improve the Progression free survival and Overall survival. The study can help us determine the toxicity profile with dose escalation as well.	To compare the locoregional control(LRC) at 3 \| months between dose escalation arm vs standard \| arm.

Secondary Outcome Measures

Name	Time	Method
1. Comparison of the quality of life between both	arms using EORTC QLQ HN35 questionnaire at

Locations (1): Jawaharlal Institute of Postgraduate Medical Education & Research
🇮🇳
Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education & Research
🇮🇳Pondicherry, PONDICHERRY, India
Ranalawala Murtuza Hakimuddin
Principal investigator
9834050814
murranala@gmail.com