Oral Cancer Adjuvant Therapy (OCAT) Trial
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.
Procedure: Post-operative chemoradiotherapy / accelerated radiotherapy
|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|
- Local-regional failure
- Overall survival
- Treatment related toxicity
- Protocol compliance
- Overall treatment time
- Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H&N-35
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||June 2017|
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
- Arm 1 (Control arm): Surgery followed by conventional radiotherapy
- Arm 2: Surgery followed by Concurrent chemo-radiotherapy
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193843
|Contact: Rohini W. Hawaldar, BSc, DCM||91-22-24177000 ext firstname.lastname@example.org|
|Contact: Kasturi R Awatagiri, B.Sc.Nursing||91-22-24177000 ext email@example.com|
|Dr. Mandar. S. Deshpande, Tata Memorial Hospital, Parel||Recruiting|
|Mumbai, Maharashtra, India, 400012|
|Contact: Mandar S Deshpande, MS,DNB 91-22-24177000 ext 7218 firstname.lastname@example.org|
|Contact: Rohini W Hawaldar, B.Sc, DCM 91-22-24177000 ext 4265 email@example.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|
|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|