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

RECRUITINGPhase 2/3Sponsored by All India Institute of Medical Sciences
Actively Recruiting
PhasePhase 2/3
SponsorAll India Institute of Medical Sciences
Started2026-02-10
Est. completion2028-06-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

CancerSquamous Cell Carcinoma Head and Neck Cancer (HNSCC)

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