Status:
ACTIVE_NOT_RECRUITING
Adjuvant Radiotherapy in Early Stage Oral Cancers
Lead Sponsor:
Tata Memorial Hospital
Collaborating Sponsors:
NATIONAL CANCER GRID
Conditions:
Cancer of Mouth
Cancer of the Tongue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 popu...
Detailed Description
The aim of this study is to assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having a tumor depth of invasion more than or equal ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Prior h/o any other malignancy in the last five years
- Prior therapeutic irradiation of the head and neck.
Key Trial Info
Start Date :
August 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT03853655
Start Date
August 2 2018
End Date
September 30 2026
Last Update
April 23 2024
Active Locations (8)
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1
Dr. B Barooah Cancer Institute
Guwahati, Assam, India, 781016
2
HCG Hospital
Ahmedabad, Gujarat, India, 380006
3
Kailash Cancer Hospital and Research Centre
Goraj, Gujarat, India, 391760
4
Sree Sankara Cancer Hospital
Bangalore, Karnataka, India, 560004