Skipping Radiotherapy to Neck Lymph Nodes After Surgery for Oral Cavity Cancer
Tests leaving out neck radiotherapy after surgery in people with oral cavity cancer.
Plain-language title generated from the registry record
Registry title: A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
Key facts
- Where
- Jhajjar, IndiaSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07528495, who can take part
Where in India
- Nci, AiimsJhajjar, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- All India Institute of Medical Sciences
- Trial code
- NCT07528495
- Record updated
- 6 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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); pT1-2 disease and no high risk features; Pathologically N2/N3 disease; Patients that require re-irradiation for recurrent disease; Age < 18 years or > 70 years; Non squamous histology; Presences of distant metastases; Inadequate neck dissection (less than 12 nodes examined); Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done; Brandwein-Gensler (BG) histological risk not done.