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NCT Number: NCT03923998

Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Indrayani hospital and cancer institute

Pune, Maharshtra, 412105, India

About this study

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:

  • Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
  • Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
  • 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.
  • Definitive surgical procedure with reconstruction by prefabricated flap, 6 weeks post radiotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Neoadjuvant chemotherapy

Drug

Three weekly concurrent chemotherapy with cisplatin 100 mg /m2

Other names: NACT

Neoadjuvant radiotherapy

Radiation

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

Other names: NACTRT

Resection and reconstruction

Procedure

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

Other names: Mandibulectomy/Maxillectomy and reconstruction by free fibula flap

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Indrayani Hospital and Cancer Institute

Other

Collaborators

  • Grant Medical Foundation Ruby hall Clinic
  • Tata Capital Limited

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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