Trial Outcomes & Findings for Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer (NCT NCT02243358)
NCT ID: NCT02243358
Last Updated: 2023-10-27
Results Overview
Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-10-27
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Chemo-Radiotherapy and Resection
2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation)
Folfox6
Gemcitabine
Radiation Therapy
Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Chemo-Radiotherapy and Resection
n=24 Participants
2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation)
Folfox6
Gemcitabine
Radiation Therapy
Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race reported · White
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race reported · Black
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race reported · Hispanic
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race reported · Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 13 patients underwent pancreatectomy after completion of neoadjuvant CRT
Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing
Outcome measures
| Measure |
Neoadjuvant Chemo-Radiotherapy and Resection
n=13 Participants
2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation)
Folfox6
Gemcitabine
Radiation Therapy
Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
|
|---|---|
|
Frequency of R0 Resection
R0 resection
|
11 Participants
|
|
Frequency of R0 Resection
R1 resection
|
2 Participants
|
Adverse Events
Neoadjuvant Chemo-Radiotherapy and Resection
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neoadjuvant Chemo-Radiotherapy and Resection
n=24 participants at risk
2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation)
Folfox6
Gemcitabine
Radiation Therapy
Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
2/24 • Consent to 1 year post completion of protocol therapy
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
8/24 • Consent to 1 year post completion of protocol therapy
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.8%
5/24 • Consent to 1 year post completion of protocol therapy
|
|
Metabolism and nutrition disorders
Fatigue
|
70.8%
17/24 • Consent to 1 year post completion of protocol therapy
|
|
Gastrointestinal disorders
Nausea
|
87.5%
21/24 • Number of events 22 • Consent to 1 year post completion of protocol therapy
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
9/24 • Number of events 9 • Consent to 1 year post completion of protocol therapy
|
|
Gastrointestinal disorders
Decreased appetite
|
41.7%
10/24 • Consent to 1 year post completion of protocol therapy
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
4/24 • Consent to 1 year post completion of protocol therapy
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
4/24 • Consent to 1 year post completion of protocol therapy
|
|
Nervous system disorders
Neuropathy
|
25.0%
6/24 • Consent to 1 year post completion of protocol therapy
|
|
Gastrointestinal disorders
Mucositis
|
12.5%
3/24 • Consent to 1 year post completion of protocol therapy
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
2/24 • Consent to 1 year post completion of protocol therapy
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
3/24 • Consent to 1 year post completion of protocol therapy
|
|
Nervous system disorders
Cold intolerance
|
8.3%
2/24 • Consent to 1 year post completion of protocol therapy
|
|
Nervous system disorders
Abdominal pain
|
8.3%
2/24 • Consent to 1 year post completion of protocol therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place