Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies
Recruiting
Phase 2
Phase 3
Interventional Study
Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 369 (estimated)
- Sponsor
- All India Institute of Medical Sciences · Other
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About This Trial
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.…
Trial Locations
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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 …
Contacts