Ignite Creation Date:
2024-05-06 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03652428
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2018-08-22
Brief Title:
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer LAPC
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase I Study of Concurrent Nab-Paclitaxel Gemcitabine With Hypofractionated Ablative Proton Therapy for Locally Advanced Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer You will receive proton therapy once a day Monday - Friday for 3 weeks Participants will also receive chemotherapy on each Monday of those three weeks
Detailed Description:
The investigators propose a phase I trial to determine the maximum tolerable dose MTD and the recommended dose for phase II RP2D of concurrent nab-paclitaxel gemcitabine in combination with ablative IMPT delivered as a fixed dose of 675 Gy in 15 fractions daily fractions with 5 fractions per week In contrast to prior pancreatic cancer studies of chemoradiotherapy which utilized photon RT to treat gross disease and elective lymph nodes 12 the proposed study is hypothesized to reduce toxicity risk by limiting highly conformal IMPT to the gross tumor volume Furthermore to increase the margin of safety in a manner similar to published data from MDACC 3 the high dose region will be limited to areas at least 5 mm from nearby GI structures duodenum small bowel stomach etc Regions within this area will be treated only to 375 Gy in 15 fractions This dose limitation is also important given that paclitaxel in addition to increasing systemic efficacy is a known radiosensitizer 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None