Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02170090
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2014-06-18
Brief Title:
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma ACTICCA-1 Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
ACTICCA-1
Brief Summary:
This is a multicenter prospective randomized controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs standard of care observation alone in stage 1 and capecitabine and observation in stage 2 in patients after curative intent resection of BTC
Detailed Description:
The ACTICCA-1 investigator initiated trial is funded by the Deutsche Krebshilfe grant number 70110215 70112047 With respect to data obtained in the ABC-02 trial the combination of cisplatin and gemcitabine for 24 weeks as investigational treatment was selected Based on adjuvant trials in pancreatic cancer eg ESPAC IV with a comparable postoperative recovery time inclusion of patients within a maximum interval of 16 weeks between surgery and start of CTx was chosen Gemcitabine and cisplatin has a relevantly higher cumulative dose of gemcitabine 18 vs 12 applications and may thus be of increased efficacy compared to the gemcitabineoxaliplatin regimen applied in the PRODIGE 12 trial
Based on the data of the BILCAP trial showing an improvement in median overall survival for capecitabine compared to observation alone presented at the annual meeting of the American Society of Clinical Oncology on June 4th 2017 in Chicago by the British BILCAP trial group capecitabine has evolved as the new standard of care after curative intent resection of biliary tract cancer
Based on these data the comparative efficacy of gemcitabinecisplatin and capecitabine had to be established
Therefore the ACTICCA trial was amended to compare gemcitabine and cisplatin to the newly established standard regimen in the adjuvant setting capecitabine aiming for superiority of the combination regimen vs the oral monotherapy This was based on the BILCAP protocol applying the similar dosing assessments and dose modifications as in BILCAP including dose calculation and patient diary
As data of recent trials like the French PRODIGE 12ACCORD 18 trial have clearly shown that in terms of efficacy of an adjuvant chemotherapy there is no difference between cholangiocarcinoma and gall bladder carcinoma these two subtypes are pooled and location was added as an stratification factor
Randomization will be 11 with adjuvant CTx for 24 weeks and imaging every 12 weeks in the experimental arm and standard of care capecitabine and observation in the control arm
The primary endpoint is DFS and secondary endpoints include recurrence free survival OS safety and tolerability of adjuvant CTx quality of life and patterns of disease recurrence
Based on the data of the BILCAP trial showing an improvement in median overall survival for capecitabine compared to observation alone presented at the annual meeting of the American Society of Clinical Oncology on June 4th 2017 in Chicago by the British BILCAP trial group capecitabine has evolved as the new standard of care after curative intent resection of biliary tract cancer
Based on these data the comparative efficacy of gemcitabinecisplatin and capecitabine had to be established
Therefore the ACTICCA trial was amended to compare gemcitabine and cisplatin to the newly established standard regimen in the adjuvant setting capecitabine aiming for superiority of the combination regimen vs the oral monotherapy This was based on the BILCAP protocol applying the similar dosing assessments and dose modifications as in BILCAP including dose calculation and patient diary
As data of recent trials like the French PRODIGE 12ACCORD 18 trial have clearly shown that in terms of efficacy of an adjuvant chemotherapy there is no difference between cholangiocarcinoma and gall bladder carcinoma these two subtypes are pooled and location was added as an stratification factor
Randomization will be 11 with adjuvant CTx for 24 weeks and imaging every 12 weeks in the experimental arm and standard of care capecitabine and observation in the control arm
The primary endpoint is DFS and secondary endpoints include recurrence free survival OS safety and tolerability of adjuvant CTx quality of life and patterns of disease recurrence
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTRN12615001283561 | REGISTRY | ANZCTR clinical trial registry | None |
| 2012-005078-70 | EUDRACT_NUMBER | None | None |