Trial Outcomes & Findings for Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma (NCT NCT01206296)
NCT ID: NCT01206296
Last Updated: 2021-03-09
Results Overview
Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
TERMINATED
PHASE2
9 participants
Occurring during hospitalization or within 30 days of surgery, whichever is longer
2021-03-09
Participant Flow
Participant milestones
| Measure |
Intraperitoneal Gemcitabine
Intraperitoneal Gemcitabine
Intraperitoneal Gemcitabine: Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2
Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Occurring during hospitalization or within 30 days of surgery, whichever is longerPopulation: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Additional efforts were made to obtain study data via publications, IRB and RedCap systems. No study data are available.
Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
Outcome measures
Outcome data not reported
Adverse Events
Intraperitoneal Gemcitabine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
MedStar Health Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place