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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nci, Aiims
  Jhajjar, Haryana, India Recruiting

Study contacts

• Study coordinator: Aman Sharma, MD
• Email: amans757@gmail.com
• Phone: +91117018529339

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.