Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers
Condition: Squamous Cell Carcinoma of Oral Cavity
MeSH terms: Mouth Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Oral cancer is the single largest cancer in males in India. 90-95% cases of oral cancer are
      Squamous cell carcinomas and many of them present at late stages (T3 and above). Treatment of
      OSCC includes single modality surgery, radiotherapy, or combinations of these modalities with
      or without systemic therapy. For unresectable cases, radiotherapy and/or chemotherapy is the
      treatment modality. Efficacy of neoadjuvant chemoradiotherapy for resectable stage IV tumors
      (late stage) needs to be evaluated to assess its benefit before surgery.
    

Detailed description: 
      This study will assess the benefit of preoperative adjuvant chemoradiotherapy in patients
      with an Stage IVa oral squamous cell carcinoma (OSCC). The study population will consist of
      patients who have not been treated previously. Patients satisfying the inclusion-exclusion
      criteria will be included in the study after obtaining a valid, written and informed consent.
      After reviewing the histopathological report, the patients will be treated as per the study
      protocol. The patients will be under regular follow-up with 3 monthly intervals for a period
      of one year and 6 monthly period in the following years. At each follow-up, patients will be
      evaluated clinically for evidence of locoregional tumor recurrence. The locoregional
      recurrence-free survival will be calculated based on the difference between the date of
      inclusion and the date of biopsy-proven recurrence. We will also record the overall survival,
      parameters like trismus, osteonecrosis and xerostomia. Quality of life will be assessed at a
      regular interval of 1 year using the University of Washington Quality of Life Questionnaire
      (UW-QOL v.4)

      Study protocol:

        1. Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys

        2. Three weekly concurrent chemotherapy with cisplatin 100 mg /m2

        3. Initial surgery in leg for Prefabrication of fibula - 2 weeks after starting of
           radiotherapy treatment. Delay is required for planning of implant position in the
           fibula.

        4. Definitive surgical procedure with reconstruction by prefabricated flap, 6 weeks post
           radiotherapy.
    

Intervention name(s): Neoadjuvant chemotherapy; Neoadjuvant radiotherapy; Resection and reconstruction
Intervention type(s): Drug; Radiation; Procedure
Intervention description(s): Three weekly concurrent chemotherapy with cisplatin 100 mg /m2; Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys; Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft
Other intervention name(s): NACT; NACTRT; Mandibulectomy/Maxillectomy and reconstruction by free fibula flap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral neoplasms; Mouth neoplasms