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Comparative study between a 6 days per week versus 5 days per week radiotherapy schedule with weekly chemotherapy in head and neck cancer patients

Comparative evaluation of Accelerated Radiotherapy with concurrent Chemotherapy versus conventional fractionation chemoradiotherapy in head and neck cancers using Volumetric Modulated Arc Therapy: A Prospective Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101377
Enrollment
70
Registered
2026-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: - Health Condition 2: - Health Condition 3: C051- Malignant neoplasm of soft palate

Interventions

Intervention1: Radiation therapy: Radiation therapy 6 fractions per week as opposed to conventionally used 5 fractions per week with weekly Cisplatin at 40mg/sq m in both arms Control Intervention1: C

Sponsors

All India Institute of Medical Sciences, Bathinda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy proven squamous cell carcinoma of head and neck. Patients who did not receive any prior management for the malignancy like surgery, radiotherapy or chemotherapy. Patients having malignancy in nasopharynx, oropharynx, hypopharynx and larynx amongst the subsites of head and neck. Patients with malignancy of aforementioned sites of Stage II, III, IV A and IV B Patients performance status should be less than or equal to 2 according to ECOG. Patients who are willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients less than 18yrs of age or more than equal to 70 years of age Patients having malignancy in lips, oral cavity, nasal cavities and paranasal sinuses. Patients who received prior management in the form of surgery, radiation or chemotherapy ECOG score more than 2 Patients with metastatic disease Patients with deranged renal function Patients not willing to give written consent

Design outcomes

Primary

MeasureTime frame
To compare the locoregional control rates in both the arms.Timepoint: To compare the locoregional control rates in both the arms at the end of 6 months

Secondary

MeasureTime frame
1. To compare the disease-free survival rates in each arm of the study. 2. To assess and compare toxicities as well as compliance in both the arms.Timepoint: both at 6 months

Countries

India

Contacts

Public ContactSneha Bose

All India Instituteof Medical Sciences, Bathinda

drsnehabose@gmail.com8777531744

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026