A study to compare the outcome and side effects of treatment of Head and Neck Cancers with either Radiation (5 days/ Week) and concurrent chemotherapy OR Radiation therapy only (6 days/Week)

A PROSPECTIVE RANDOMIZED STUDY TO COMPARE DISEASE RESPONSE AND TOXICITY IN CONVENTIONAL FRACTIONATION WITH CONCURRENT CISPLATIN VERSUS ACCELERATED RADIOTHERAPY IN LOCALLY ADVANCED HEAD NECK CANCER - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099054

Enrollment

Registered

2025-12-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: C13- Malignant neoplasm of hypopharynx Health Condition 2: C329- Malignant neoplasm of larynx, unspecified Health Condition 3: C10- Malignant neoplasm of oropharynx

Interventions

Intervention1: Accelerated Radiotherapy (RT) alone: 66 70 Gy in 33 35 fractions, 2 Gy/day, 6 days/week for 6 weeks, No chemotherapy Control Intervention1: Conventional Chemoradiotherapy (RT + weekly C

Eligibility

Inclusion criteria

Inclusion criteria: 1. All histological proven cases of primary malignancy of Head & Neck (locally advanced: T1 to T2 with node positive, T3, T4a, T4b) including Oropharynx, Hypopharynx, Larynx. 2. Age between 18-70 years, with Performance Status ECOG 0-2. 3. Normal haematological parameters- Haemoglobin more than 10gm/dl(patients should be transfused before treatment to achieve this level). Total leucocyte count more than 4,000/cu.mm and less than 12,000/cu.mm OR ANC more than 1500. Platelet count more than 1,00,000/cu.mm. Serum Urea less than 45 mg/dl and Serum creatinine less than 1.5mg/dl. 4. Patients willing to participate in the study with a written and informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous history of Radiotherapy in Head and Neck region. 2. Patients with collagen vascular disease or any other systemic uncontrolled comorbidities or severe uncontrolled infection, which may alter treatment outcome. 3. Pregnant or nursing women. 4. Patients who had impaired liver function, bone marrow suppression & renal dysfunction. 5. Recurrent disease

Design outcomes

Primary

Measure	Time frame
Overall disease response at 12 weeks after completion of treatment.Timepoint: Weekly during Radiotherapy. Follow-up after 1 month then 3 monthly.	—

Secondary

Measure	Time frame
Assessment of toxicities Timepoint: Weekly during Radiotherapy. Follow-up after 1 month then 3 monthly.	—

Countries

India

Contacts

Public ContactDr Pabitra Das

INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH

anupamm321@gmail.com9800136661

Outcome results

None listed

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