Oral Cancer Adjuvant Therapy (OCAT) Trial

December 23, 2005 updated by: Tata Memorial Hospital

Phase III Trial of Surgery Followed by Conventional RT(5fr/Week)Vs.Concurrent Chemo-Radiotherapy Vs.Accelerated RT(6fr/Week)in High Risk, Loco-Regionally Advanced, Stage III&IVA, Resectable, Squamous Cell Carcinomas of Oralcavity

To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral cavity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Locally advanced, stage III and IVA, resectable, squamous cell carcinomas of oral cavity are conventionally treated with surgery, followed by post-operative radiotherapy. Local-regional recurrence remains the most frequent cause of failure of this treatment. The results of conventional therapy are dismal with five-year survival of less than 30% and 60-80% incidence of local-regional failure within 3 years. There are various known histological prognostic factors. The local-regional control and overall survival are extremely poor in high risk patients with these poor prognostic factors. In an attempt to improve the outcome of this high risk group, various alternative treatment policies such as addition of chemotherapy to radiotherapy or altered fractionation schedules have been tried. But till date, there is no alternative treatment modality with acceptable toxicity, available for these patients.

Aims Of Study: To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral cavity.

Eligibility criteria: Locally advanced, stage III and IVA, resectable, squamous cell carcinomas of oral cavity with one of the following poor prognostic factors extracapsular nodal extension, involvement of > 2 regional lymph nodes, margin of resection with invasive cancer Extensive soft tissue and / or skin infiltration requiring major reconstructive procedure.

Peri-neural invasion with positive lymph node. Lympho-vascular embolisation with positive lymph node.

Trial Design The eligible patients will be randomly allocated to one of the three arms

  1. Arm 1 (Control arm): Surgery followed by conventional radiotherapy
  2. Arm 2: Surgery followed by Concurrent chemo-radiotherapy
  3. Arm 3: Surgery followed by Accelerated radiotherapy

Surgery: Surgery will be same in all three arms. Wide excision tumour with appropriate nodal dissection and reconstruction utilizing accepted criteria for the region involved will be done.

Radiotherapy: Total dose of radiotherapy will be 56 - 60 Gy. Patients in Arms 1 and 2, five fractions per week for six weeks. Patients in Arm 3, six fractions a week for five weeks.

Chemotherapy: Patients in Arm 2 will get weekly chemotherapy (Inj Cisplatin 30 mg / m2)

Stratification: Patients will be stratified according to following factors Site: Gingivo-buccal complex cancers Vs Tongue and Floor of mouth cancers. T stage. N stage. Extra-capsular spread (Peri-nodal extension) Surgical margin Extensive soft tissue infiltration

End points Primary end point: Local-regional failure. Secondary end point: Overall survival. Other parameters to be assessed are Treatment related toxicity Protocol compliance Overall treatment time Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H&N-35 Sample size: 900 pts (300 pts in each arm). Duration of accrual: 7 years. Duration of follow up: 5 years. With minimum follow up of 2 years. Analysis: Intent to treat analysis will be done. Interim analysis will be done after 450 patients (150 pts in each arm)

Study Type

Interventional

Enrollment

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rohini W. Hawaldar, BSc, DCM
  • Phone Number: 4265 91-22-24177000
  • Email: tmhcrs@vsnl.com

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Dr. Mandar. S. Deshpande, Tata Memorial Hospital, Parel
        • Contact:
        • Contact:
          • Rohini W Hawaldar, B.Sc, DCM
          • Phone Number: 4265 91-22-24177000
          • Email: tmhcrs@vsnl.com
        • Sub-Investigator:
          • Anil K D'cruz, MS,DNB
        • Sub-Investigator:
          • Devendra A Chaukar, MS,DNB
        • Sub-Investigator:
          • Pankaj C Chaturvedi, MS
        • Sub-Investigator:
          • Prathamesh P Pai, MS, DORL
        • Sub-Investigator:
          • Sarbani S Laskar, MD,DMRT
        • Sub-Investigator:
          • Jai P Agarwal, MD
        • Sub-Investigator:
          • Rajendra L Bhalavat, MD,DMRT
        • Sub-Investigator:
          • Ketayun A Dinshaw, FRCR,DMRT
        • Sub-Investigator:
          • Venkatesh R Pai, MD
        • Sub-Investigator:
          • Kunnisherry M Mohandas, MD,DNB
        • Sub-Investigator:
          • Shubhada V Kane, MD
        • Sub-Investigator:
          • Tejpal Gupta, MD,DNB
        • Sub-Investigator:
          • Aashish A Bakshi, MD,DM
        • Sub-Investigator:
          • Amish D Vora, MD,DM
        • Sub-Investigator:
          • Kumar Prabhash, MD,DM
        • Sub-Investigator:
          • Ashwini N Budrukkar, MD,DMRT
        • Sub-Investigator:
          • Kasturi R Awatagiri, B.Sc. Nsg
        • Sub-Investigator:
          • Rohini W Hawaldar, B.Sc.DCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Previously untreated, resectable, loco-regionally advanced, stage III & IV, biopsy-proven squamous cell carcinoma of the oral cavity. (Clinically lower stage patients will also be included if upstaged to pathological stage III or IV after Surgery)

One or more of the following must be present:

extracapsular nodal extension, involvement of > 2 regional lymph nodes, margin of resection with invasive cancer (on histopathology) Extensive soft tissue and / or skin infiltration requiring major reconstructive procedure.

Peri-neural invasion with positive lymph node(s). Lymphovascular embolisation with positive lymph node(s). Age > 18. Karnofsky performance status of > 60. WBC > 3500, platelets > 100,000 Serum creatinine < 1.2 mg / m2 Signed study-specific informed consent form. Protocol treatment must begin within 8 weeks surgery.

Exclusion Criteria:

Gross (visible or palpable) residual disease left after surgery. Prior chemotherapy or radiation therapy to the head and neck region.

Evidence of distant metastasis. Any post-operative complication which will delay starting of adjuvant treatment for more than 8 weeks.

Presence of synchronous or concurrent head and neck primary tumors. Prior malignancy within the previous 5 years. Patients who because of their medical status are not candidates for the proposed treatment.

KPS < 60. Age > 65 years. Poor expected follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Local-regional failure

Secondary Outcome Measures

Outcome Measure
Overall survival
Treatment related toxicity
Protocol compliance
Overall treatment time
Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H&N-35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Investigators

  • Principal Investigator: Mandar S Deshpande, MBBS,MS,DNB, Tata Memorial Hospital, Parel, Mumbai 12, Maharashtra, India
  • Principal Investigator: Mandar S Deshpande, MBBS,MS,DNB, Tata Memorial Hospital, Parel, Mumbai 12 .Maharshtra, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

June 1, 2017

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

December 26, 2005

Last Update Submitted That Met QC Criteria

December 23, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMH/177/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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