AREST in Early stage Oral cancer

Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST) – a prospective randomized control trial.

Study design / Type : A prospective randomized control trial

1. Tata Memorial Centre Mumbai. (Coordinating Centre)
2. Amrita Institute Of Medical Sciences, Kochi.
3. Mazumdar Shaw Medical Centre, Bangalore.
4. HCG Hospital, Ahmedabad.
5. B Barooah Cancer Institute, Guwahati.
6. Kailash Cancer Hospital & Research Center, Goraj
7. Shri Shankara Cancer Hospital-Bengaluru
8. Malabar Cancer Centre-Thalassery

Oral cancer is one of the commonest cancer affecting men in India. Surgery is the preferred initial mainstay of treatment for these patients in our institute. The predominant pattern of failure for oral cancers remains loco-regional recurrence. Various retrospective reports including data from Tata Memorial Centre suggests that depth of invasion is an important factor affecting prognosis in early stage oral cancers. Some centers therefore, advice adjuvant radiotherapy for these tumors based on tumor thickness / depth of invasion alone even in the absence of other adverse prognostic factors. However, no direct evidence exists for the effectiveness of radiotherapy in improving disease-related outcomes in patients with depth of invasion as the only adverse prognostic factor.

The aim of this study is to assess the benefit of post-operative adjuvant radiotherapy in patients with an early stage oral squamous cell carcinoma (OSCC). The hypothesis is that postoperative adjuvant radiotherapy would significantly reduce the risk of loco-regional recurrence in patients with tumor thickness ≥5 mm compared to observation alone after definitive surgical treatment of the primary cancer and the neck node desection.