Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

Squamous Cell Carcinoma of Oral Cavity Clinical Trial

Official title:

Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923998
• Other study ID #: OIT415
• Status: Completed
• Phase: Early Phase 1
• Start date: March 15, 2016
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2019
• Source: Indrayani Hospital and Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Mouth Neoplasms
• Squamous Cell Carcinoma of Oral Cavity

Intervention

Drug:
• Neoadjuvant chemotherapy
Three weekly concurrent chemotherapy with cisplatin 100 mg /m2

Radiation:
• Neoadjuvant radiotherapy
Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys

Procedure:
• Resection and reconstruction
Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft

Locations

Country	Name	City	State
India	Indrayani hospital and cancer institute	Pune	Maharshtra

Sponsors (3)

Lead Sponsor	Collaborator
Indrayani Hospital and Cancer Institute	Grant Medical Foundation Ruby hall Clinic, Tata Capital Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	This will be deduced from pathological response in terms of complete and partial response. Complete response is defined as no invasive and no in situ residuals present in the surgical specimen. Partial response defined as at least a 30% reduction in the size of the lesion in the surgical specimen.	Upto 1 year
Primary	Disease free survival	Disease-free survival will be calculated as the time interval (months) between primary treatment and the first recurrence (whether local, regional or distant).	2 years
Primary	Overall Survival	Overall Survival will be calculated as the time interval (months) between primary treatment and death.	2 years
Secondary	Quality of life assessment	Patient reported 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). The minimum score is 0 which is indicative of worse outcome while 100 is the maximum score and indicative of better outcome. Various parameters including chewing, pain, swallowing, saliva, appearance etc. are included in the questionnaire. Average score for each parameter with standard deviation will be reported.	2 years