Oral Cancer Adjuvant Therapy (OCAT) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2005 by Tata Memorial Hospital
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193843
First received: September 13, 2005
Last updated: December 23, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Mouth Neoplasms
Procedure: Post-operative chemoradiotherapy / accelerated radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Local-regional failure

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

Estimated Enrollment: 900
Study Start Date: June 2005
Estimated Study Completion Date: June 2017
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193843

Contacts
Contact: Rohini W. Hawaldar, BSc, DCM 91-22-24177000 ext 4265 tmhcrs@vsnl.com
Contact: Kasturi R Awatagiri, B.Sc.Nursing 91-22-24177000 ext 4254 awatagiri2002@yahoo.com

Locations
India
Dr. Mandar. S. Deshpande, Tata Memorial Hospital, Parel Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Mandar S Deshpande, MS,DNB    91-22-24177000 ext 7218    mandarsd@yahoo.com   
Contact: Rohini W Hawaldar, B.Sc, DCM    91-22-24177000 ext 4265    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         
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00193843     History of Changes
Other Study ID Numbers: TMH/177/2004
Study First Received: September 13, 2005
Last Updated: December 23, 2005
Health Authority: India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:
Oral cancer
Head and neck surgery
Accelerated radiotherapy
Chemo-radiotherapy

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 22, 2014