Short-course (3-week) versus standard 6-week postoperative radiation for head and neck squamous cell carcinoma
Official title: 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
Run by All India Institute of Medical Sciences · NCT07573956 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 369 (estimated) |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Jhajjar, Haryana) |
| Status | Recruiting |
| Started | February 10, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | December 30, 2028 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07573956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Nivolumab-IRDyE800CW imaging agent used before surgery in head and neck cancer
This early-stage trial tests whether nivolumab labeled with IRDye800CW can safely be given before surgery to see if it helps image head and neck squamous cell carcinoma.
-
Ivonescimab with or without ligufalimab versus pembrolizumab as first-line treatment for recurrent/metastatic PD-L1-positive head and neck squamous cell carcinoma
This study tests whether ivonescimab alone or with ligufalimab works as a first-line treatment for PD-L1‑positive recurrent or metastatic head and neck cancer, compared with pembrolizumab.
-
ICG dye imaging to help find head and neck tumors during surgery
We will try a fluorescent dye called ICG during surgery to see if it helps surgeons find tumor tissue in adults with mucosal head and neck squamous cell cancer who are at risk of recurrence.
-
Immune response in neck lymph nodes of people with head and neck cancer.
This project will test whether immune and genetic differences between the primary tumor and nearby neck lymph nodes, including sentinel nodes, indicate whether cancer has spread in people with HNSCC.
-
Testing blood samples for cancer DNA in head and neck cancer patients
This study is testing if checking blood samples for cancer DNA can help predict if head and neck cancer patients will have a relapse after their treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.