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Oral cancer patients may avoid unnecessary radiation to the neck

NCT ID NCT07528495

Disease control Sponsor: All India Institute of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether it is safe to skip radiation to the lymph nodes in the neck after surgery for early-stage oral cancer. About 396 adults aged 18-70 with certain high-risk features will be randomly assigned to receive or not receive this radiation. The goal is to see if skipping it leads to similar cancer control in the neck area, reducing side effects without harming outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 396 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms oral cavity squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Nci, Aiims

    RECRUITING

    Jhajjar, Haryana, 124105, India

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