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A study comparing conventional radiotherapy with short course Radiotherapy in inoperable oral cancer.

Randomised comparative study between concomitant chemoradiotherapy with conventional fractionation and hypofractionation radiotherapy in unresectable locally advanced carcinoma of the oral cavity.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087805
Enrollment
30
Registered
2025-05-28
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: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Hypofractionated Radiotherapy: Hypo fractionated radiotherapy with 55Gy in 20 fractions, 2.75Gy per fraction, single fraction per day, 5 fractions per week for a total of 4 weeks. Contr

Sponsors

Dr Ankur Saha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All histological and/or cytological proven cases of primary malignancy of Squamous cell carcinoma of the oral cavity. Unresectable and Locally advanced disease. Age between 18 to 70 years, with Performance Status ECOG 0,1,2. Previously untreated for any type of cancer. Normal haematological parameters. Patients willing to participate in the study with a written and informed consent.

Exclusion criteria

Exclusion criteria: Previous history of Radiotherapy in Head and Neck region. Patients with collagen vascular disease or any other systemic comorbidities or severe uncontrolled infection, which may alter treatment outcome. Pregnant or nursing women. Patients who had impaired liver function, bone marrow suppression & renal dysfunction. Recurrent disease

Design outcomes

Primary

MeasureTime frame
Response assessment Timepoint: at baseline, after completion of radiation, at 3 months, at 6 months, at 9 months, at 12 months.

Secondary

MeasureTime frame
Assessment of ToxicitiesTimepoint: at baseline, after completion of radiotherapy, 3 months, 6 months, 9 months, months

Countries

India

Contacts

Public ContactDr Amitabha Manna

Institute of Post Graduate Medical Education and Research and SSKM Hospital

amitavamanna1965@gmail.com9433009577

Outcome results

None listed

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