A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
Recruiting
Phase 2
Phase 3
Interventional Study
Head and Neck Cancer
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.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 396 (estimated)
- Sponsor
- All India Institute of Medical Sciences · Other
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About This Trial
The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Aged 18 or above and less than 70 years
2. Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
3. Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or …
Contacts