Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193843
Status:
UNKNOWN
Last Update Posted:
2005-12-26
First Post:
2005-09-13
Brief Title:
Oral Cancer Adjuvant Therapy OCAT Trial
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
Phase III Trial of Surgery Followed by Conventional RT5frWeekVsConcurrent Chemo-Radiotherapy VsAccelerated RT6frWeekin High Risk Loco-Regionally Advanced Stage IIIIVA Resectable Squamous Cell Carcinomas of Oralcavity
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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-HN-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
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-HN-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None