Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

Indrayani Hospital and Cancer Institute

Status and phase: Completed; Early Phase 1

Conditions: Squamous Cell Carcinoma of Oral Cavity

Treatments: Drug: Neoadjuvant chemotherapy; Procedure: Resection and reconstruction; Radiation: Neoadjuvant radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03923998

OIT415

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed stage IVa squamous cell carcinoma of the oral cavity.
2. Surgically resectable oral squamous carcinoma with invasion of mandible or maxilla.
3. Newly diagnosed or previously untreated squamous cell carcinoma of the oral cavity.

Exclusion criteria

1. Patients with distant metastases.
2. Patients with contraindication to radiotherapy.
3. Patients with vascular disorders or ischemic heart disease. -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Neoadjuvant chemoradiotherapy followed by surgery

Experimental group

Description:

Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery

Treatment:

Radiation: Neoadjuvant radiotherapy

Procedure: Resection and reconstruction

Drug: Neoadjuvant chemotherapy