Ignite Creation Date:
2024-05-06 @ 2:24 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02035072
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2014-01-10
Brief Title:
Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
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:
Title Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer
Protocol code IRST15701
Phase II
Study Design monocentric prospective open-label not randomized trial
Description of Study Treatment radio-chemotherapy schedule
GEMOX Gemcitabine GEM 1000 mgm2 day 1 and Oxaliplatin OX 100 mgm2 day 2 every 2 weeks for 4 cycles
Hypofractionated radiotherapy 35 Gy in 7 fractions in 9 consecutive days one session per day excluding Saturday and Sunday administered 15 days after the 4th chemotherapy cycle
Further 4 cycles of GEMOX starting 7-15 days after the end of the radiotherapy
Objectives
Step A primary objective to evaluate the safety of radiotherapy treatment Secondary objective the control of IM internal margin intra-fraction
Step B primary objective to evaluate the proportion of the resectable patients after radio-chemotherapy Secondary objectives overall Response Rate ORR safety profile of combinated treatmentoverall survival OS local progression free survival LPFS and progression free survival PFS
Statistical Considerations
Step A
Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20 11 patients are to be evaluated for toxicity If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients the treatment can be considered safe with a probability 90 If 1 toxicity involving the radiotherapy treatment discontinuation will be observed 7 more patients needs to be recruited If no further toxicity involving the radiotherapy treatment discontinuation occurs the treatment could be considered safe with a probability 90
If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed the study will be stopped because not safe and another kind of radiotherapy schedule must be designed
Step B
If the radiotherapy treatment will be considered no toxic the study will continue in Step B the goal of this phase II study is to increase the proportion of resectable patients of at least 15 with the new radio-chemotherapeutic treatment By using the single-stage design Gehan EA J Chron Dis 1961 a total of 40 patients is required to be recruited in 2 years and a further one-year period of follow-up is requested If at least 7 patients out of 40 enrolled will be resectable the hypothesis that the proportion of resectable patients will be less or equal to P1 P1the proportion of resectable patients with the new radio-chemotherapeutic treatment will be refused and the treatment could be considered active
Protocol code IRST15701
Phase II
Study Design monocentric prospective open-label not randomized trial
Description of Study Treatment radio-chemotherapy schedule
GEMOX Gemcitabine GEM 1000 mgm2 day 1 and Oxaliplatin OX 100 mgm2 day 2 every 2 weeks for 4 cycles
Hypofractionated radiotherapy 35 Gy in 7 fractions in 9 consecutive days one session per day excluding Saturday and Sunday administered 15 days after the 4th chemotherapy cycle
Further 4 cycles of GEMOX starting 7-15 days after the end of the radiotherapy
Objectives
Step A primary objective to evaluate the safety of radiotherapy treatment Secondary objective the control of IM internal margin intra-fraction
Step B primary objective to evaluate the proportion of the resectable patients after radio-chemotherapy Secondary objectives overall Response Rate ORR safety profile of combinated treatmentoverall survival OS local progression free survival LPFS and progression free survival PFS
Statistical Considerations
Step A
Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20 11 patients are to be evaluated for toxicity If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients the treatment can be considered safe with a probability 90 If 1 toxicity involving the radiotherapy treatment discontinuation will be observed 7 more patients needs to be recruited If no further toxicity involving the radiotherapy treatment discontinuation occurs the treatment could be considered safe with a probability 90
If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed the study will be stopped because not safe and another kind of radiotherapy schedule must be designed
Step B
If the radiotherapy treatment will be considered no toxic the study will continue in Step B the goal of this phase II study is to increase the proportion of resectable patients of at least 15 with the new radio-chemotherapeutic treatment By using the single-stage design Gehan EA J Chron Dis 1961 a total of 40 patients is required to be recruited in 2 years and a further one-year period of follow-up is requested If at least 7 patients out of 40 enrolled will be resectable the hypothesis that the proportion of resectable patients will be less or equal to P1 P1the proportion of resectable patients with the new radio-chemotherapeutic treatment will be refused and the treatment could be considered active
Detailed Description:
None
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 |
|---|---|---|---|
| 2010-020379-22 | EUDRACT_NUMBER | None | None |