Trial Outcomes & Findings for Study of Proton Therapy in Adjuvant Pancreatic Cancer (NCT NCT03885284)
NCT ID: NCT03885284
Last Updated: 2024-10-24
Results Overview
Recommended phase II dose and schedule (RP2D) of short-course PRT integrated within adjuvant mFOLFIRINOX will be based on number of Dose limiting toxicities.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
6 months
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Dose Level 1
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Dose Level 1
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Study of Proton Therapy in Adjuvant Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsRecommended phase II dose and schedule (RP2D) of short-course PRT integrated within adjuvant mFOLFIRINOX will be based on number of Dose limiting toxicities.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Incidence of Dose Limiting Toxicites (DLTs)
|
0 Dose limiting Toxicities
|
1 Dose limiting Toxicities
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: number of participants that had a dose limiting toxicity.
Dose Limiting Toxicities. Adverse Event data will be collected and presented as descriptive statistics using the CTCAE version 5.0
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Safety (Adverse Events) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsSuccess rate defined as # of patients that completed proton beam planning, proton beam treatment, and completion of adjuvant therapy
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Feasibility (Rate of Successful Completion) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
Completion PRT
|
3 Participants
|
6 Participants
|
|
Feasibility (Rate of Successful Completion) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
completion of proton beam planning
|
3 Participants
|
6 Participants
|
|
Feasibility (Rate of Successful Completion) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
completion of proton beam treatment
|
3 Participants
|
6 Participants
|
|
Feasibility (Rate of Successful Completion) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
completion of adjuvant therapy
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsDefined as time from surgery until evidence of disease recurrence.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Recurrence-free Survival (RFS)
|
12 months
Interval 4.0 to
Upper Bound Not Reached due to insufficient number of participants with events
|
12 months
Interval 4.0 to
Upper bound Not Reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 2 yearsDefined as time from surgery until death from any cause or last follow-up.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 Participants
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Overall Survival (OS)
|
2 Participants
|
4 Participants
|
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 participants at risk
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
Dose Level 2
n=6 participants at risk
mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6
mFOLFIRINOX: Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
* Irinotecan 150 mg/m2 IV day 1
* Oxaliplatin 85 mg/m2 IV day 1
* Leucovorin 400 mg/m2 IV day 1
* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.
Proton beam radiation: Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 2 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 2 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
0.00%
0/6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
50.0%
3/6 • Number of events 3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
General disorders
Pain
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
0.00%
0/6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
33.3%
2/6 • Number of events 3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
0.00%
0/6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
0.00%
0/6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 2 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
0.00%
0/6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Investigations
Weight loss
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
0.00%
0/6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
83.3%
5/6 • Number of events 6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
33.3%
2/6 • Number of events 2 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
1/3 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
0.00%
0/6 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
16.7%
1/6 • Number of events 1 • AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place