Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04520074
Status:
RECRUITING
Last Update Posted:
2022-07-27
First Post:
2020-08-18
Brief Title:
Adjuvant Chemotherapy of Three-step Regimen in BRCA12 Wide Type Ovarian Cancer ACTS-2
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase IIIRandomized Multi-center Open Label Study of Adjuvant Chemotherapy of Three-step Regimens ACTS in BRCA12 Wide-type Stage III and Stage IV Epithelial Ovarian Fallopian Tube and Primary Peritoneal Cancer EOC FTC PPC
Status:
RECRUITING
Status Verified Date:
2022-07
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:
None
Brief Summary:
Ovarian cancer was mostly diagnosed at late stage IIIIV with high rate of recurrence after first line of therapy by optimal cytoreductive sugery and 6cycle of TP chemotherapy There is no standard maintainance therapy for BRCA12 wide-type ovarian cancer We developed an adjuvant chemotherapy of three steps ACTS It is adding CTXVP-16second step 6cycle and CTXCBPthird steps to firstline chemotherapy first step The aim of this study is to verify the effectivity and safety of ACTS in BRCA12 wide-type ovarian cancer patients
Detailed Description:
More than 70 percent of ovarian cancer patients were diagnosed in the advanced stage Currently the 5-year disease free survival DFS of stageⅢ-Ⅳovarian cancer patients was about 10 percent after first line chemotherapy Dr Cai shumo developed adjuvant chemotherapy of three steps ACTS for advanced ovarian cancer after cytoreductive surgery based on his 60 years experience on gynecologic oncology After the first step 6-8 cycle paclitaxel plus carboplatin chemotherapy the chemo-sensative cancer cells were killed but resistantdormancy cell remained The second step chemotherapy which is 6 cycle CTXVP-16 every 4weeks using different mechanism to kill cancer cells may decrease the rate of recurrence within 6 month after first step chemotherapy prolong platinum-free duration and also with acceptable side effects After second step chemotherapy in absence of 6 months platinum treatment the previous G0 dormancy cell may become flexible to platinum treatment Therefore in the third step chemotherapy CTXCBP is used in every 8 week for 6 cycles Comparing to using targeted therapy for maintaining therapy the ACTS cost less
In the previous observation studyCHINA ONCOLOGY 2013 Vol23 No12 p980 In study arm A the patients received three-step chemotherapy after primary debulking surgery step one with paclitaxel plus carboplatin TC regimen every 3 weeks for 6 to 8 cycles step two with etoposide plus cyclophosphamide every 4 weeks for 6 cycles step three with carboplatin plus cyclophosphamide every eight weeks for six cycles In control arm B investigators retrospectively analysed 51 cases withⅢC-Ⅳstage ovarian cancer who had completely response after standard chemotherapy with six to eight cycles of TC after primary surgery during 2007 Investigators compared the 5-year DFS between the two arms Results The 5-year DFS of 15 cases in arm A was 801215 which was signiifcantly higher than that of arm B 59 351 P001 Therefore we start this randomized open control clinic trial to evaluated the effect of ACTS on overall survival and its safety
In2015 we launched ACTS study NCT02562365 and the primary results showed benefit of ACTS on PFS and acceptable AE Currently PARP inhibit was shown to be effective in maintainance therapy in ovarian cancer especially approve for BRCA12 mutated pateints However there is no standard maintainance therapy for BRCA12 wide-type ovarian cancer Here we started ACTS-2 study to verify the effectivity and safety of ACTS in BRCA12 wide-type ovarian cancer patients
In the previous observation studyCHINA ONCOLOGY 2013 Vol23 No12 p980 In study arm A the patients received three-step chemotherapy after primary debulking surgery step one with paclitaxel plus carboplatin TC regimen every 3 weeks for 6 to 8 cycles step two with etoposide plus cyclophosphamide every 4 weeks for 6 cycles step three with carboplatin plus cyclophosphamide every eight weeks for six cycles In control arm B investigators retrospectively analysed 51 cases withⅢC-Ⅳstage ovarian cancer who had completely response after standard chemotherapy with six to eight cycles of TC after primary surgery during 2007 Investigators compared the 5-year DFS between the two arms Results The 5-year DFS of 15 cases in arm A was 801215 which was signiifcantly higher than that of arm B 59 351 P001 Therefore we start this randomized open control clinic trial to evaluated the effect of ACTS on overall survival and its safety
In2015 we launched ACTS study NCT02562365 and the primary results showed benefit of ACTS on PFS and acceptable AE Currently PARP inhibit was shown to be effective in maintainance therapy in ovarian cancer especially approve for BRCA12 mutated pateints However there is no standard maintainance therapy for BRCA12 wide-type ovarian cancer Here we started ACTS-2 study to verify the effectivity and safety of ACTS in BRCA12 wide-type ovarian cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None