NCT07573956 Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies
| NCT ID | NCT07573956 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | All India Institute of Medical Sciences |
| Condition | Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 369 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 369 participants in total. It began in 2026-02-10 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Dr. Aman Sharma
PRINCIPAL INVESTIGATOR
National cancer Institute, AIIMS, Jhajjar
Frequently Asked Questions
Who can join the NCT07573956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Squamous Cell Carcinoma Head and Neck Cancer (HNSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07573956 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07573956 currently recruiting?
Yes, NCT07573956 is actively recruiting participants. Contact the research team at amans757@gmail.com for enrollment information.
Where is the NCT07573956 trial being conducted?
This trial is being conducted at Jhajjar, India.
Who is sponsoring the NCT07573956 clinical trial?
NCT07573956 is sponsored by All India Institute of Medical Sciences. The principal investigator is Dr. Aman Sharma at National cancer Institute, AIIMS, Jhajjar. The trial plans to enroll 369 participants.
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