Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
NCT07573956

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

Led by All India Institute of Medical Sciences · Updated on 2026-05-07

369

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

Sponsors

A

All India Institute of Medical Sciences

Lead Sponsor

I

Indian Council of Medical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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

Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS

Jhajjar, Haryana, India

Actively Recruiting

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Research Team

D

Dr. Aman Sharma

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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