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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

Clinicaltrials.gov identifier NCT03923998

Recruitment Status Completed

First Posted April 23, 2019

Last update posted April 23, 2019

Study Description

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.

  • Condition or Disease:Squamous Cell Carcinoma of Oral Cavity
  • Intervention/Treatment: Drug: Neoadjuvant chemotherapy
    Radiation: Neoadjuvant radiotherapy
    Procedure: Resection and reconstruction
  • Phase: Early Phase 1
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 8 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.
  • Actual Study Start Date: March 2016
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 2019
Arms and interventions
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

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
Outcome Measures
  • Primary Outcome Measures: 1. Objective response rate [ Time Frame: Upto 1 year ]
    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.
  • 2. Disease free survival [ Time Frame: 2 years ]
    Disease-free survival will be calculated as the time interval (months) between primary treatment and the first recurrence (whether local, regional or distant).
  • 3. Overall Survival [ Time Frame: 2 years ]
    Overall Survival will be calculated as the time interval (months) between primary treatment and death.
  • Secondary Outcome Measures: 1. Quality of life assessment [ Time Frame: 2 years ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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. -

Contacts and Locations
Contacts
Locations

India, Maharshtra
Indrayani hospital and cancer institute
Pune

Sponsors and Collaborators

Indrayani Hospital and Cancer Institute

Tata Capital Limited

Grant Medical Foundation Ruby hall Clinic

Investigators

Principal Investigator: Sanjay Deshmukh, MS Indrayani Hospital and Cancer Institute

More Information
  • Responsible Party: Indrayani Hospital and Cancer Institute
  • ClinicalTrials.gov Identifier: NCT03923998 History of Changes
  • Other Study ID Numbers: OIT415
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: April 23, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Individual patient data for all primary and secondary outcomes will be made available.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Indrayani Hospital and Cancer Institute: Oral neoplasms Mouth neoplasms
  • Additional relevant MeSH terms: Mouth Neoplasms