Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies

NCT07573956 · tracked via the Priya Life Science India tracker

Sponsor

All India Institute of Medical Sciences

Phase

Phase 2/3

Started

2026-02-10

Last updated

2026-05-07

Condition(s) studied

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Investigational drug(s) / intervention(s)

Standard conventionally fractionated PORThypo-fractionated PORT

Standard conventionally fractionated PORT: 60Gy in 30 fractions over 6 weeks (5 fractions per week)

hypo-fractionated PORT: 4Gy in 15 fractions over 3 weeks (5 fractions per week)

Study summary

Hypo-fractionated radiotherapy reduces the OTT (overall treatment time) which may in turn reduce rapid accelerated repopulation of clonogenic cells during waiting period after surgery. If this holds true, there is a potential to achieve better loco-regional control in with PORT for HNSCC. There is a strong radiobiological and economic rationale for delivery hypo-fractionated radiotherapy in HNSCC. The HYPCON III trial will be aimed to reduce the number of fractions by 50% (30 fr to 15 fr)

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Patients with pT1-4 squamous cell carcinoma of oral cavity/ oropharynx/ larynx/ hypopharynx with any of the intermediate risk features: * Positive lymph node (s) * Perineural invasion * Lympho-vascular invasion * Close margins * Age 18-80yrs * ECOG performance status 0-1at time of surgery * Informed consent * Available FOR long term follow-up Exclusion Criteria: * High risk factors following resection: positive-margin(s)and/or extra nodal extension (ENE) * pT1-2disease and no high-risk features (LVSI, PNI, Close margins,pN0) * Patients receiving Neo-adjuvant or concurrent Chemotherapy * Non-Squamous Histology * Distant metastasis * Synchronous or second primary malignancy outside of the oropharynx, oral cavity, larynx and hypopharynx * Pregnant females or nursing mothers due to the probability of congenital anomalies and potential of this regimen to harm nursing infants. * Prior Radiotherapy to head and neck region

Primary outcome measure(s)

loco-regional control at 24 months — 24 months

Trial sites (1)

Facility	City	Region	Status
Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS	Jhajjar	Haryana	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07573956 on ClinicalTrials.gov ↗ ← All trials in India