Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in India / NCT07528495
Recruiting Phase 2/3

A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's

NCT07528495 · tracked via the Priya Life Science India tracker
Sponsor
All India Institute of Medical Sciences
Phase
Phase 2/3
Started
2024-04-03
Last updated
2026-05-06

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

IMRT - adjuvant concurrent CRT/ RTommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphaticsCisplatin →

IMRT - adjuvant concurrent CRT/ RT: IMRT - adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr to primary and regional lymphatics

ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics: IMRT- adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr / Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only \- elimination of regional lymphatics

Cisplatin: Cisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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 PNI, pT3-4 4. At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck) 5. Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity 6. Brandwein-Gensler (BG) histological risk assessment in all patients 7. Karnofsky performance score greater or equal 70 8. Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version. 9. Timely delivery of PORT preferable within 6weeks of surgery (upto 1-2 weeks of delay beyond 6 weeks is permissible to accommodate for delayed wound healing or other logistics) 10. Written informed consent for treatment. 11. Available to attend long term follow- up Exclusion Criteria: 1. Non squamous histology 2. Presences of distant metastases 3. pT1-2 disease and no high risk features 4. Pathologically N2/N3 disease. 5. Patients that require re-irradiation for recurrent disease 6. Inadequate neck dissection (less than 12 nodes examined) 7. Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done 8. Initiation of PORT after 8 weeks of radical surgery. 9. Previous radiotherapy to the head and neck region 10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ). 11. Age \< 18 years or \> 70 years 12. Brandwein-Gensler (BG) histological risk not done

Primary outcome measure(s)

  • Regional control — 2 years
    Regional control will be assessed as occurrence of any new lesion in the regional /nearby area over time with the help of radiological imaging (CT/MRI/PET-CT) and clinical examination. will be assessed at 3 months, 6 months, 12 months, 18 months, 24 months

Trial sites (1)

FacilityCityRegionStatus
Nci, Aiims Jhajjar Haryana Recruiting

More All India Institute of Medical Sciences trials in India

Lesioning Procedures for Movement Disorders Starting soon
AIRCARE (Air Pollution and Cancer Research Ecosystem): Center for Advanced Research on Environmental Health and Lung Cancer Risk Starting soon
Smartphone Use Restriction as Treatment of Primary Headache Recruiting
HYPOfractionated RadioTherapy in Cervical Cancer Recruiting
Comparative Evaluation of Endodontic Instrumentation Kinematics and Cryotherapy on Post-endodontic Pain and Periapical Healing Active, not recruiting

Other trials for the same condition

ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07528495 on ClinicalTrials.gov ↗ ← All trials in India