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
|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|
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)
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.|
|Actual Study Start Date :||March 15, 2016|
|Actual Primary Completion Date :||March 15, 2019|
|Actual Study Completion Date :||March 15, 2019|
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 Name: NACT
Radiation: Neoadjuvant radiotherapy
Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
Other Name: NACTRT
Procedure: Resection and reconstruction
Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft
Other Name: Mandibulectomy/Maxillectomy and reconstruction by free fibula flap
- 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.
- 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).
- Overall Survival [ Time Frame: 2 years ]Overall Survival will be calculated as the time interval (months) between primary treatment and death.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923998
|Indrayani hospital and cancer institute|
|Pune, Maharshtra, India, 412105|
|Principal Investigator:||Sanjay Deshmukh, MS||Indrayani Hospital and Cancer Institute|