A Study Testing Shorter duration Radiotherapy Combined with Chemotherapy for People with Inoperable Mouth Cancer.

A PHASE II SINGLE ARM STUDY OF HYPOFRACTIONATED CHEMORADIATION IN UNRESECTABLE ORAL CAVITY SQUAMOUS CELL CARCINOMA (OCSCC).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107996

Enrollment

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

Interventions

Intervention1: A PHASE II SINGLE ARM STUDY OF HYPOFRACTIONATED CHEMORADIATION IN UNRESECTABLE ORAL CAVITY SQUAMOUS CELL CARCINOMA (OCSCC).: The patient diagnosed with a cancer of mouth where surgery i

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years. 2. ECOG PS 0-2. 3. Histologically confirmed Oral Cavity Squamous cell carcinoma (OCSCC). 4. Inoperable Loco-regionally advanced OCSCC - deemed inoperable still after 2 to 3 cycles of platinum doublet chemotherapy but amenable for curative intent treatment. 5. Having non-metastatic disease. 6. Having a baseline estimated GFR of at least 60 ml/min or more. Patients with an estimated GFR of <60 ml/min can be taken if an EDTA-GFR scan is feasible in time and the patient is eligible for Carboplatin administration. 7. Adequate marrow, liver function tests and serum electrolytes conditions which doesn t exclude administration of chemotherapy 8. Informed consent.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To estimate the median Overall survival of unresectable Oral cavity Squamous Cell Carcinoma being treated with definitive hypofractionated chemoradiationTimepoint: 1 year	—

Secondary

Measure	Time frame
Median Progression free survival of unresectable Oral cavity Squamous Cell Carcinoma being treated with definitive hypofractionated chemoradiationTimepoint: To estimate the proportion of patients achieving Complete response, Partial Response Stable disease & Progressive disease. Patient will be assessed after 1 week, 6 weeks & every three months till one year post Radiation.	—

Countries

India

Contacts

Public ContactDr. Mohamed Samroud Mohamed

JIPMER

docswarna26@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026