Adjuvant Radiotherapy in Early Stage Oral Cancers (NCT03853655) | Clinical Trial Compass
CompletedNot Applicable
Adjuvant Radiotherapy in Early Stage Oral Cancers
India392 participantsStarted 2018-08-02
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. pT3/pT4 (as specified in the AJCC 8th edition).
✕. Depth of invasion \< 5mm.
What they're measuring
1
loco-regional recurrence free survival
Timeframe: Date of randomization to loco regional recurrence (date of proven biopsy date) or at the end of 36 months after recruitment of the last participant.