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

Randomized Controlled Trial on Efficacy of DOSe-Escalation Radiotherapy for Curative Treatment in Patients with Inoperable Oral Cavity Carcinoma-DOSE-ROC - DOSE-ROC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088227

Enrollment

Registered

2025-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Interventions

Intervention1: Escalated Dose Radiotherapy with/without Concurrent Chemotherapy: Patients in the intervention arm will receive radiation therapy to a total dose of 72.6 Gy in 33 fractions: 66 Gy in 30

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: To compare the locoregional control(LRC) at 3 months between dose escalation arm vs standard arm.	—

Secondary

Measure	Time frame
1. Comparison of the quality of life between both arms using EORTC QLQ HN35 questionnaire at baseline & 3 months post treatment. 2. Proportion of patients developing acute side effects of radiation using acute RTOG toxicity scoring criteria & CTCAE version 5.0 toxicity criteria. 3. To compare progression free survival(PFS) & median overall survival(OS) in the intervention group versus the control group. Timepoint: Quality of life will be assessed at baseline & 3 months post-treatment; acute toxicities (RTOG & CTCAE v5.0) will be recorded weekly during radiotherapy & at 1 & 6 weeks post-treatment; & progression-free survival (PFS) & overall survival (OS) will be monitored continuously during follow-up at 3-month intervals for 3 years.	—

Measure

Time frame

1. Comparison of the quality of life between both arms using EORTC QLQ HN35 questionnaire at baseline & 3 months post treatment. 2. Proportion of patients developing acute side effects of radiation using acute RTOG toxicity scoring criteria & CTCAE version 5.0 toxicity criteria. 3. To compare progression free survival(PFS) & median overall survival(OS) in the intervention group versus the control group. Timepoint: Quality of life will be assessed at baseline & 3 months post-treatment; acute toxicities (RTOG & CTCAE v5.0) will be recorded weekly during radiotherapy & at 1 & 6 weeks post-treatment; & progression-free survival (PFS) & overall survival (OS) will be monitored continuously during follow-up at 3-month intervals for 3 years.

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Countries

India

Contacts

Public ContactRanalawala Murtuza Hakimuddin

Jawaharlal Institute of Postgraduate Medical Education & Research

ambioncologist@gmail.com8940866067

Outcome results

None listed

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