NCT03853655Completed
Adjuvant Radiotherapy in Early Stage Oral Cancers
Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST)
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
This study will assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having tumor thickness more than or equal to 5mm. The study population will consist of patients who have been treated by surgery for early stage oral tongue cancers. Patients with a close or positive margin (\</= 5mm) and or with metastatic neck node(s) will be excluded. Selected patients will be randomized into two groups. The group I will be observed after surgery and group II will receive adjuvant radiotherapy as per protocol.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 392 (actual)
- First submitted
- 20 Jun 2017
- Start date
- 2 Aug 2018
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT03853655
What you commit to
- Study type: Interventional
- Participants enrolled: 392
- From 2 Aug 2018 to the primary completion date, 15 Dec 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior h/o any other malignancy in the last five years
- Prior therapeutic irradiation of the head and neck.
Other
- pT3/pT4 (as specified in the AJCC 8th edition).
- Depth of invasion \< 5mm.
- Any neck nodal metastasis with or without extra nodal extension
- Tumor-free margin \< 5 mm
- Non-squamous histology
- Pregnant woman
Who the study is looking for
- 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.
- 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.)
- Written informed consent.
- Age ≥18 years
- Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2
- The depth of invasion (DOI) ≥ 5 mm.
- Compliance to therapy and follow-up
- The interval from surgery to adjuvant radiotherapy ≤ 6 weeks
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HCG Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Mazumdar Shaw Medical Centre Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Sree Sankara Cancer Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Kailash Cancer Hospital and Research Centre Coordinator of this site? Confirm its status | Goraj | India | Unknown status |
| Dr. B Barooah Cancer Institute Coordinator of this site? Confirm its status | Guwahati | India | Unknown status |
| Malabar Cancer Centre Coordinator of this site? Confirm its status | Kannur | India | Unknown status |
| Amrita institute of Medical Sciences Coordinator of this site? Confirm its status | Kochi | India | Unknown status |
| Tata Memorial Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.