Selective neck dissection (levels I–IV) vs. modified neck dissection (levels I–V) in oral cavity cancer with a positive neck

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

The ExteNT N1 Trial is a randomized, open-label study comparing selective neck dissection (levels I–IV) to modified neck dissection (levels I–V) in patients with resectable cN1 oral cavity squamous cell carcinoma. Participants are assigned 1:1 to receive one of the two surgical approaches, with the primary endpoint being 3-year regional recurrence-free survival. The study aims to determine if reducing the dissection extent can maintain oncologic control while potentially reducing morbidity and improving postoperative function and quality of life. Secondary considerations include operative time, complications, and patient-reported outcomes, within a rigorously designed trial framework. Eligible patients have histologically confirmed oral cavity squamous cell carcinoma, clinical stage T1–T4, N1, M0, and a single FNAC-proven metastatic node, among other criteria. The trial is conducted at Kolhapur Cancer Centre in India under the sponsorship of Kolhapur Cancer Centre – Cancer Centers of America.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven squamous cell carcinoma of oral cavity will be included
* Clinical stage T1-T4, N1, M0
* cN1 neck on clinical examination and imaging (CT/MRI)
* Single node which is FNAC proven without any other significant nodes.
* Patients with ASA grade II and I.
* Understands the protocol and able to give informed consent.

Exclusion Criteria:

* Recurrent cases
* Multiple significant nodes
* Nodes clinical/radiological with ENE
* Single metastatic node at level III/IV/V
* Single metastatic node with other suspicious nodes
* Patients with a history of head and neck radiation therapy treatment
* Previous history of any malignancy

Where it's running

• Kolhapur Cancer Centre
  Kolhāpur, Maharashtra, India Recruiting

Study contacts

• Study coordinator: Maroti B Wadewale, MDS, FHNO
• Email: dr.marotiwadewale59@gmail.com
• Phone: +918483851334

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Proton or Photon Radiotherapy Added to Pembrolizumab Before Surgery for Advanced or Recurrent Oral Cavity Cancer

  This phase 2 trial tests whether adding proton SFRT or SBRT to pembrolizumab before surgery helps patients with advanced or recurrent oral cavity cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07783581

• Personalized neck radiation guided by sentinel lymph node biopsy for oral cavity cancer

  This phase II trial sees if using sentinel lymph node biopsy to guide which side(s) of the neck get radiation can safely reduce unnecessary radiation for people with oral cavity squamous cell carcinoma.

  Recruiting Phase 2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07121595

• Personalized compartment-sparing postoperative radiation for head and neck cancer

  This trial tests whether targeted, compartment-sparing postoperative radiation can reduce side effects while keeping cancer control for people with surgically treated head and neck squamous cell carcinoma.

  Recruiting at 3 sites Phase 2 Insel Gruppe AG, University Hospital Bern · Basel and 2 other locations · NCT07058805

• Cemiplimab with or without CDX-1140 given before surgery for stage III-IV head and neck cancer

  This trial tests whether adding the immune stimulant CDX-1140 to cemiplimab before surgery helps shrink tumors in people with resectable stage III-IV head and neck squamous cell carcinoma.

  Recruiting at 12 sites Phase 2 National Cancer Institute (NCI) · Irvine, California and 11 other locations · NCT06980038

• Immune biomarker testing in cisplatin-ineligible head and neck squamous cell cancer patients treated with chemoradiation and docetaxel

  This project will test whether immune markers from tumor tissue, blood, saliva and stool can help predict outcomes and show increased tumor immune activity in people with oropharynx, hypopharynx, larynx or oral cavity squamous cell cancer who can't take cisplatin and are receiving chemoradiation with docetaxel.

  Recruiting University of Erlangen-Nürnberg Medical School · Erlangen, Bavaria · NCT06947668

• Remote hearing tests for patients with head and neck cancer receiving chemotherapy or radiation

  This study is testing if remote hearing tests can help patients with advanced head and neck cancer keep track of their hearing loss during chemotherapy or radiation, making it easier for those who live far away to participate.

  Recruiting Emory University · Atlanta, Georgia · NCT06662058

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.