Clinical trial NCT03923998: Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers
Official title: Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Squamous Cell Carcinoma of Oral Cavity
Keywords: Oral neoplasms
Mouth neoplasms
Lead sponsor: Indrayani Hospital and Cancer Institute
Sponsor class: OTHER
Collaborators: name: Tata Capital Limited
name: Grant Medical Foundation Ruby hall Clinic
First posted: 2019-04-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Objective response rate
timeFrame: Upto 1 year
measure: Disease free survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Pune
country: India
facility: Indrayani hospital and cancer institute
state: Maharshtra
Study officials:
affiliation: Indrayani Hospital and Cancer Institute
name: Sanjay Deshmukh, MS
role: PRINCIPAL_INVESTIGATOR
References: