RecruitingPhase 2Phase 3NCT07573956

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

The HYPCON 3 Trial A Phase II/III Randomized Study Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant Radiation Therapy in Head and Neck Malignancies

Sponsor

All India Institute of Medical Sciences

Enrollment

369 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

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 Criteria8

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