NCT07528495RecruitingPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 6 Dec 2022
- Start date
- 3 Apr 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- All India Institute of Medical Sciences
- Diseases
- Head and neck cancer
- NCT number
- NCT07528495
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 396
- From 3 Apr 2024 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- pT1-2 disease and no high risk features
- Pathologically N2/N3 disease.
- Patients that require re-irradiation for recurrent disease
Age
- Age \< 18 years or \> 70 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nci, Aiims Coordinator of this site? Confirm its status | Jhajjar | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.