A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
The Eliminate Trial: A Phase II/III Randomised Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's in pN0/N1 Neck for Oral Cavity Carcinomas
All India Institute of Medical Sciences
396 participants
Apr 3, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- Aged 18 or above and less than 70 years
- Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
- Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
- At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)
- Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity
- Brandwein-Gensler (BG) histological risk assessment in all patients
- Karnofsky performance score greater or equal 70
- Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
- 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)
- Written informed consent for treatment.
- Available to attend long term follow- up
Exclusion Criteria12
- Non squamous histology
- Presences of distant metastases
- pT1-2 disease and no high risk features
- Pathologically N2/N3 disease.
- Patients that require re-irradiation for recurrent disease
- Inadequate neck dissection (less than 12 nodes examined)
- Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done
- Initiation of PORT after 8 weeks of radical surgery.
- Previous radiotherapy to the head and neck region
- Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
- Age < 18 years or > 70 years
- Brandwein-Gensler (BG) histological risk not done
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Interventions
IMRT - adjuvant concurrent CRT/ RT as 66Gy/60 Gy in 33/30 fractions to primary and regional lymphatics
IMRT- adjuvant concurrent CRT/ RT as 66Gy/60 Gy in 33/30 fractions/ Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only \- elimination of regional lymphatics
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07528495