Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

• Sponsor: Indrayani Hospital and Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03923998
• Collaborator: Tata Capital Limited (Other), Grant Medical Foundation Ruby hall Clinic (Other)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 0.2

Study Details

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	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Oral Cavity	Drug: Neoadjuvant chemotherapy; Radiation: Neoadjuvant radiotherapy; Procedure: Resection and reconstruction	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
• Allocation: N/A
• 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: Mar 15, 2016
• Actual Primary Completion Date: Mar 15, 2019
• Actual Study Completion Date: Mar 15, 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; 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

Outcome Measures

Primary Outcome Measures

1. Objective response rate [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Indrayani hospital and cancer institute	Pune	Maharshtra	India	412105

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Sanjay Deshmukh, Surgical Oncologist, Indrayani Hospital and Cancer Institute
• ClinicalTrials.gov Identifier: NCT03923998
• Other Study ID Numbers: OIT415
• First Posted: Apr 23, 2019
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Sanjay Deshmukh, Surgical Oncologist, Indrayani Hospital and Cancer Institute: Oral neoplasms; Mouth neoplasms
• Additional relevant MeSH terms: Mouth Neoplasms

Study Results

No Results Posted as of Apr 23, 2019