Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

NCT03923998 | Completed Early Phase 1 DMC

• 1 other identifier: OIT415
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of Oral Cavity

Keywords

Oral neoplasms; Mouth neoplasms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Quality of life assessment

  2 years

Study Arms (1)

Neoadjuvant chemoradiotherapy followed by surgery

EXPERIMENTAL

Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery

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

Interventions

Neoadjuvant chemotherapy DRUG

Three weekly concurrent chemotherapy with cisplatin 100 mg /m2

Also known as: NACT

Neoadjuvant chemoradiotherapy followed by surgery

Neoadjuvant radiotherapy RADIATION

Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys

Also known as: NACTRT

Neoadjuvant chemoradiotherapy followed by surgery

Resection and reconstruction PROCEDURE

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

Also known as: Mandibulectomy/Maxillectomy and reconstruction by free fibula flap

Neoadjuvant chemoradiotherapy followed by surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with distant metastases.
• Patients with contraindication to radiotherapy.
• Patients with vascular disorders or ischemic heart disease. -

Sponsors & Collaborators

• Indrayani Hospital and Cancer Institute: lead
• Tata Capital Limited: collaborator
• Grant Medical Foundation Ruby hall Clinic: collaborator

Study Sites (1)

Indrayani hospital and cancer institute

Pune, Maharshtra, 412105, India

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Interventions

Neoadjuvant Therapy; Plastic Surgery Procedures; Mandibular Osteotomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Surgical Procedures, Operative; Orthognathic Surgical Procedures; Oral Surgical Procedures; Dentistry

Study Officials

• Sanjay Deshmukh, MS

  Indrayani Hospital and Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncologist

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 23, 2019
• Study Start: March 15, 2016
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be made available 4 months post completion of the study.
• Access Criteria: The data will be made available on request. Requestors will need to sign a data access agreement to obtain the data.

Locations

IN (1)