Actively Recruiting
A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
Led by All India Institute of Medical Sciences · Updated on 2026-05-06
396
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
All India Institute of Medical Sciences
Lead Sponsor
A
All India Institute of Medical Sciences, Rishikesh
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or above and less than 70 years
- Histologically confirmed pT1-4 squamous cell carcinoma of the oral cavity
- Undergoing radical excision and ipsilateral or bilateral neck dissection
- Presence of high-risk features: positive or close (≤ 5mm) surgical margin, lymphovascular invasion, perineural invasion, or pT3-4 tumor stage
- At least one dissected hemi-neck with 12 or more lymph nodes recovered
- Pathological N0 or N1 neck status with high-risk features receiving radiotherapy
- Brandwein-Gensler histological risk assessment performed
- Karnofsky performance score of 70 or higher
- Ability to complete MD Anderson Dysphagia Inventory and EORTC quality of life questionnaires in English or Hindi
- Postoperative radiotherapy preferably started within 6 weeks of surgery (up to 1-2 weeks delay allowed for wound healing or logistics)
- Written informed consent for treatment
- Available for long-term follow-up
You will not qualify if you...
- Non-squamous cell carcinoma histology
- Presence of distant metastases
- pT1-2 disease without high-risk features
- Pathological N2 or N3 neck disease
- Need for re-irradiation due to recurrent disease
- Inadequate neck dissection (less than 12 lymph nodes examined)
- Primary tumor reaching within 1 cm of midline with only ipsilateral neck dissection
- Postoperative radiotherapy initiated later than 8 weeks after surgery
- Previous radiotherapy to head and neck region
- Any invasive malignancy within past 2 years except non-melanomatous skin cancer or cervical carcinoma in situ
- Age under 18 or over 70 years
- Brandwein-Gensler histological risk assessment not performed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nci, Aiims
Jhajjar, Haryana, India, 124105
Actively Recruiting
Research Team
A
Aman Sharma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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