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出境医 / 临床实验 / Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 15, 2016
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 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 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
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
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Ages Eligible for Study:   18 Years 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

Locations
Layout table for location information
India
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
Layout table for investigator information
Principal Investigator: Sanjay Deshmukh, MS Indrayani Hospital and Cancer Institute
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE March 15, 2016
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers
Official Title  ICMJE Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of Oral Cavity
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Neoadjuvant chemoradiotherapy followed by surgery
Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery
Interventions:
  • Drug: Neoadjuvant chemotherapy
  • Radiation: Neoadjuvant radiotherapy
  • Procedure: Resection and reconstruction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2019) 		8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2019
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923998
Other Study ID Numbers  ICMJE OIT415
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual patient data for all primary and secondary outcomes will be made available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party Dr. Sanjay Deshmukh, Indrayani Hospital and Cancer Institute
Study Sponsor  ICMJE Indrayani Hospital and Cancer Institute
Collaborators  ICMJE
  • Tata Capital Limited
  • Grant Medical Foundation Ruby hall Clinic
Investigators  ICMJE
Principal Investigator: Sanjay Deshmukh, MS Indrayani Hospital and Cancer Institute
PRS Account Indrayani Hospital and Cancer Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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