Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

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

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.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of Oral Cavity
• Intervention / Treatment: Drug: Neoadjuvant chemotherapy; Radiation: Neoadjuvant radiotherapy; Procedure: Resection and reconstruction

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• India
  • Maharshtra
    • Pune, Maharshtra, India, 412105
      • Indrayani hospital and cancer institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Neoadjuvant chemoradiotherapy followed by surgery; Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery

Drug: Neoadjuvant chemotherapy; Three weekly concurrent chemotherapy with cisplatin 100 mg /m2; Other Names: NACT; Radiation: Neoadjuvant radiotherapy; Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys; Other Names: NACTRT; Procedure: Resection and reconstruction; Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft; Other Names: Mandibulectomy/Maxillectomy and reconstruction by free fibula flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall Survival	Overall Survival will be calculated as the time interval (months) between primary treatment and death.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indrayani Hospital and Cancer Institute
• Collaborators: Tata Capital Limited; Grant Medical Foundation Ruby hall Clinic
• Investigators: Principal Investigator: Sanjay Deshmukh, MS, Indrayani hospital and cancer institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2016
• Primary Completion (ACTUAL): March 15, 2019
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (ACTUAL): April 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Oral neoplasms; Mouth neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Mouth Neoplasms
• Other Study ID Numbers: OIT415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data for all primary and secondary outcomes will be made available.
• IPD Sharing Time Frame: The data will be made available 4 months post completion of the study.
• IPD Sharing Access Criteria: The data will be made available on request. Requestors will need to sign a data access agreement to obtain the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No