Omitting post-operative radiation to neck lymph nodes after oral cavity cancer surgery

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

This trial will test whether skipping post‑operative radiotherapy to the neck lymph nodes is safe for adults (18–69) with resected pN0–pN1 oral cavity squamous cell carcinoma who have high‑risk pathological features.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 396 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: All India Institute of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Jhajjar, Haryana)
• Trial ID: NCT07528495 on ClinicalTrials.gov

What this trial studies

This randomized prospective phase II/III trial compares standard postoperative radiotherapy that includes regional neck lymphatics to postoperative radiotherapy that omits elective radiotherapy to the regional lymphatics in patients with resected oral cavity squamous cell carcinoma and pN0–pN1 nodal status. Eligible patients have high‑risk features after surgery (positive or close margins, LVI or PNI, pT3–4) and must have at least one dissected hemi‑neck with ≥12 nodes recovered; concurrent cisplatin may be given per protocol. Primary outcomes focus on loco‑regional control and overall survival, with secondary endpoints including treatment toxicity and patient‑reported swallowing and quality‑of‑life measures (MDADI, EORTC). The trial tests whether reducing radiotherapy target volumes lowers late morbidity without compromising cancer control.

Who should consider this trial

Good fit: Adults aged 18–69 with histologically confirmed oral cavity squamous cell carcinoma who underwent radical excision and neck dissection, have pN0–pN1 status with specified high‑risk features, at least one hemi‑neck with ≥12 nodes recovered, KPS ≥70, and can complete QoL assessments are ideal candidates.

Not a fit: Patients with more extensive nodal disease (for example pN2 or multiple positive nodes), extracapsular extension, or those unable to receive timely postoperative radiotherapy are unlikely to benefit from omission of regional radiotherapy.

Why it matters

Potential benefit: If successful, patients could avoid radiation to the neck and experience less long‑term toxicity such as swallowing problems, dry mouth, and fibrosis while preserving cancer control.

How similar studies have performed: Retrospective series and small prospective cohorts have suggested selective omission of elective neck irradiation can be safe in highly selected pN0–pN1 patients, but no large randomized phase II/III evidence has yet confirmed this approach.

Eligibility criteria

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

Where this trial is running

Jhajjar, Haryana

• Nci, Aiims — Jhajjar, Haryana, India (Recruiting)

Study contacts

• Study coordinator: Aman Sharma, MD

Conditions Head and Neck Cancer