Short-course (3-week) versus standard 6-week postoperative radiation for head and neck squamous cell carcinoma
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
This will test whether a shorter, 3-week postoperative radiation schedule works as well as the standard 6-week schedule for adults (18–80) who had surgery for head and neck squamous cell carcinoma with certain intermediate risk features.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 369 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Jhajjar, Haryana) |
| Trial ID | NCT07573956 on ClinicalTrials.gov |
What this trial studies
This Phase 2/3 non-inferiority study compares a resource-sparing hypo‑fractionated postoperative radiotherapy course (15 fractions over 3 weeks) with the conventional regimen (30 fractions over 6 weeks) for resected head and neck squamous cell carcinoma. Eligible patients receive adjuvant radiation using modern techniques (IMRT/VMAT/IGRT) to spare nearby organs at risk. The trial focuses on loco-regional control and toxicity while also measuring treatment duration, convenience, and resource use. High‑risk patients (positive margins or extranodal extension) and those receiving concurrent chemotherapy are excluded.
Who should consider this trial
Good fit: Adults aged 18–80 who had surgical resection for squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx with intermediate risk features (positive nodes, perineural or lymphovascular invasion, or close margins), ECOG 0–1, and able to attend long-term follow-up.
Not a fit: Patients with high-risk features such as positive margins or extranodal extension, those receiving neoadjuvant or concurrent chemotherapy, non-squamous histology, distant metastases, prior head and neck radiotherapy, or pregnant/nursing women are not expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients could get equivalent cancer control with half the number of radiation visits, making treatment shorter, more convenient, and less costly.
How similar studies have performed: Hypofractionation is established in cancers like breast and prostate and an IAEA multicenter trial in radical HNSCC reported equivalent disease control and toxicity, providing supportive precedent for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jhajjar, Haryana
- Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS — Jhajjar, Haryana, India (Recruiting)
Study contacts
- Principal investigator: Dr. Aman Sharma — National cancer Institute, AIIMS, Jhajjar
- Study coordinator: Dr. Aman Sharma
- Email: amans757@gmail.com
- Phone: +917018529339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.