Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193791
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2005-09-13
Brief Title:
Concomitant Chemoradiation in Advanced Stage Carcinoma Cervix
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
Concomitant Chemo-radiation in Advanced Stage Carcinoma Cervix A Phase III Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
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:
CRACx
Brief Summary:
A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy alone Concomitant chemoradiation is not a new treatment modality for carcinoma cervix Studies have shown improvement in survivals with chemoradiation but majority of the patients was in early stages Since this treatment modality has not been tested adequately in advanced stages in our setting the present study is being undertaken The study arm of chemoradiation has the potential to improve the survivals by 10 but is associated with additional 5 risk of toxicities which are treatable In the study arm apart form the standard radiotherapy treatment you will receive weekly chemotherapy injections Cisplatin during external radiation therapy The study arm is associated with additional 5 acute hematological and gastrointestinal toxicities which are treatable with medications blood transfusions modifications in the ongoing treatment etc
Detailed Description:
Carcinoma cervix is the commonest malignancy seen in Asian women and constitutes approximately 30 of all cancers 1 It is also the leading cause of cancer mortality in India Nearly 50 of the patients present with advanced stages FIGO Stage IIIIV The main stay of treatment has traditionally been radical radiation therapy and over decades the survival rates have achieved a plateau of 30 - 45 at 5 years In developing countries the socioeconomic problems illiteracy late presentation and irregular follow-up have further compromised our survivals Over the last decade there have been studies on the use of chemo-radiotherapy in carcinoma cervix Over 19 randomized trials have been published addressing the issue of chemo-radiotherapy However heterogeneous data poor randomization inadequate number of patients sub-optimal radiotherapy non-uniform use of chemotherapeutic drugs its sequencing and poor documentation have not yet provided the evidence to substantially alter the practice Hence meta-analysis of these trials was undertaken to further evaluate the role of chemo-radiotherapy in carcinoma cervix 23
The first meta-analysis published by Cochrane Collaborative Group of 4580 randomized patients 19 randomized trials suggested that chemo-radiation did show an absolute survival benefit improvement both in progression free and overall survivals by 16 and 12 respectively p00001 The survivals were significantly better with Cisplatin based concomitant chemo-radiation p00001 Incidentally the distant metastasis rates were also significantly lower in chemo-radiation p00001 However all these benefits were seen only in early stages In addition acute grade 34 hematological and gastro-intestinal toxicities were higher with chemo-radiation additional 8 and 5 respectively The data was insufficient to report on late toxicity 2
The second meta-analysis of 9 randomized trials recently published by the Canadian Group to evaluate only cisplatin based concomitant chemo-radiation confirms the improvement in overall survival 4year survival data in advanced stages bulky IB tumors prior to surgery and high risk early disease post-surgery Although acute grade 34 hematological and gastro-intestinal toxicities were higher in chemo-radiation they were short-lived with only 2 deaths and the remaining resolved with medical treatment There was no significant increase in the late toxicity from the data available
Both the Cochrane and Canadian meta-analysis have to a large extent tried to address the role of concomitant chemo-radiation but Carcinoma Cervix Stage III accounted for only 30-35 and moreover evaluation with optimal radiation schedules and comparison of late toxicities still remains unanswered What is more important is that the cisplatin is relatively inexpensive and is available worldwide This means that cisplatin-based chemo-radiation is affordable in the developing countries where carcinoma cervix still forms the major cancer However the role of chemo-radiation in Carcinoma Cervix Stage IIIB in a developing countries including India still remains unexplored We propose this randomized study to evaluate the role and benefit of chemo-radiation in-patients with cervical cancer
The first meta-analysis published by Cochrane Collaborative Group of 4580 randomized patients 19 randomized trials suggested that chemo-radiation did show an absolute survival benefit improvement both in progression free and overall survivals by 16 and 12 respectively p00001 The survivals were significantly better with Cisplatin based concomitant chemo-radiation p00001 Incidentally the distant metastasis rates were also significantly lower in chemo-radiation p00001 However all these benefits were seen only in early stages In addition acute grade 34 hematological and gastro-intestinal toxicities were higher with chemo-radiation additional 8 and 5 respectively The data was insufficient to report on late toxicity 2
The second meta-analysis of 9 randomized trials recently published by the Canadian Group to evaluate only cisplatin based concomitant chemo-radiation confirms the improvement in overall survival 4year survival data in advanced stages bulky IB tumors prior to surgery and high risk early disease post-surgery Although acute grade 34 hematological and gastro-intestinal toxicities were higher in chemo-radiation they were short-lived with only 2 deaths and the remaining resolved with medical treatment There was no significant increase in the late toxicity from the data available
Both the Cochrane and Canadian meta-analysis have to a large extent tried to address the role of concomitant chemo-radiation but Carcinoma Cervix Stage III accounted for only 30-35 and moreover evaluation with optimal radiation schedules and comparison of late toxicities still remains unanswered What is more important is that the cisplatin is relatively inexpensive and is available worldwide This means that cisplatin-based chemo-radiation is affordable in the developing countries where carcinoma cervix still forms the major cancer However the role of chemo-radiation in Carcinoma Cervix Stage IIIB in a developing countries including India still remains unexplored We propose this randomized study to evaluate the role and benefit of chemo-radiation in-patients with cervical cancer
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