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Radiation after surgery may keep early oral cancer at bay

NCT ID NCT03853655

Disease control Sponsor: Tata Memorial Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether giving radiation therapy after surgery can prevent early-stage oral cancer from coming back. It included 392 patients with tumors at least 5mm thick. Half received radiation, half were just watched. The main goal was to see if radiation reduced local or regional cancer recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy
What this could lead to
If successful, this could show that adding radiotherapy after surgery lowers the chance of cancer coming back in patients with early oral cancer and thick tumors.
What could go wrong
This trial is completed but results are not yet widely known. The benefit may be small, and radiotherapy has side effects like mouth sores and dry mouth. The study only included certain tumor types and thicknesses, so findings may not apply to all patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

392 people

The number who actually took part.

Started

Aug 2018

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Post-operative early stage squamous cell carcinoma of the oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth). (pT1, pT2, N0 as defined in the AJCC Classification 8th edition. 2. Adequate surgery (Defined as wide local excision of the primary tumor with tumor-free margin ≥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.) 3. Written informed consent. 4. Age ≥18 years 5. Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2 6. The depth of invasion (DOI) ≥ 5 mm. 7. Compliance to therapy and follow-up 8. The interval from surgery to adjuvant radiotherapy ≤ 6 weeks Exclusion Criteria: 1. pT3/pT4 (as specified in the AJCC 8th edition). 2. Depth of invasion \< 5mm. 3. Any neck nodal metastasis with or without extra nodal extension 4. Tumor-free margin \< 5 mm 5. Non-squamous histology 6. Pregnant woman 7. Prior h/o any other malignancy in the last five years 8. Prior therapeutic irradiation of the head and neck.

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Conditions

The condition(s) this trial relates to.

carcinoma of floor of mouth cheek mucosa cancer head and neck cancer Head and Neck Neoplasms Mouth Neoplasms oral cavity cancer oral cavity squamous cell carcinoma squamous cell carcinoma of buccal mucosa squamous cell carcinoma of floor of mouth squamous cell carcinoma of the oral tongue tongue cancer

As listed by the trial registrant

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

Buccal mucosa cancer Cancer of mouth Cancer of the head and neck Cancer of the tongue Floor of mouth carcinoma

Contacts and locations

Locations

  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682041, India

  • Dr. B Barooah Cancer Institute

    Guwahati, Assam, 781016, India

  • HCG Hospital

    Ahmedabad, Gujarat, 380006, India

  • Kailash Cancer Hospital and Research Centre

    Goraj, Gujarat, 391760, India

  • Malabar Cancer Centre

    Kannur, Kerala, 670103, India

  • Mazumdar Shaw Medical Centre

    Bangalore, Karnataka, 560100, India

  • Sree Sankara Cancer Hospital

    Bangalore, Karnataka, 560004, India

  • Tata Memorial Centre

    Mumbai, Maharashtra, 400012, India

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