Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer
Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer
Sponsor: Dana-Farber Cancer Institute
A PHASE1/PHASE2 clinical study on Pancreatic Cancer, this trial is completed. The trial is conducted by Dana-Farber Cancer Institute and has accumulated 8 data snapshots since 2007. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)* Not everyone who participates in this research study will receive the same schedule of radiation therapy. The schedule of radiation therapy will depend on the number of participants enrolled on the study and how well they have tolerated their radiation schedule. All patients will receive proton beam therapy. * Here are the proposed schedules of radiation therapy. If at any point too many subjects experience too many unacceptable side effects, no subject will be enrolled to the next level. Dose Level 1: 10 radiation sessions given Monday-Friday for two weeks. Dose Level 2: 5 radiation sessions given Monday, Wednesday and Friday in Week 1 and Tuesday and Thursday in Week 2. Dose Level 3: 5 radiation sessions given Monday, Tuesday, Thursday and Friday in Week 1 and Monday in Week 2. Dose Level 4: 5 Radiation sessions given Monday through Friday in Week 1. * In Dose Levels 2, 3 and 4, there are fewer radiation sessions, but the radiation dose given at each session is slightly higher than the dose given in each of the 10 sessions of Dose Level 1. * Capecitabine will be given orally (pill form) starting on the first day of radiation therapy and...
* Not everyone who participates in this research study will receive the same schedule of radiation therapy. The schedule of radiation therapy will depend on the number of participants enrolled on the study and how well they have tolerated their radiation schedule. All patients will receive proton beam therapy. * Here are the proposed schedules of radiation therapy. If at any point too many subjects experience too many unacceptable side effects, no subject will be enrolled to the next level. Dose Level 1: 10 radiation sessions given Monday-Friday for two weeks. Dose Level 2: 5 radiation sessions given Monday, Wednesday and Friday in Week 1 and Tuesday and Thursday in Week 2. Dose Level 3: 5 radiation sessions given Monday, Tuesday, Thursday and Friday in Week 1 and Monday in Week 2. Dose Level 4: 5 Radiation sessions given Monday through Friday in Week 1. * In Dose Levels 2, 3 and 4, there are fewer radiation sessions, but the radiation dose given at each session is slightly higher than the dose given in each of the 10 sessions of Dose Level 1. * Capecitabine will be given orally (pill form) starting on the first day of radiation therapy and will be taken for the two weeks that the participant receives radiation therapy. * On days 1, 8 and 15 of each study cycle, the participant will be seen at the clinic for: physical examination, questions about side effects; and routine blood tests. * After the last day of study treatment there will be up to a six-week rest period before surgery is performed. * About three to six weeks after the participant has finished study treatment, the following procedures will be done: CT or MRI, physical examination; questions about side effects and blood tests.
Status Flow
Change History
8 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
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Feb 2019 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
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Jul 2018 — Feb 2019 [monthly]
Completed PHASE1_PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Jul 2018 [monthly]
Completed PHASE1_PHASE2
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Jan 2018 — Jun 2018 [monthly]
Completed PHASE1_PHASE2
Status: Active Not Recruiting → Completed
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Jan 2017 — Jan 2018 [monthly]
Active Not Recruiting PHASE1_PHASE2
First recorded
Dec 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Dana-Farber Cancer Institute
- Massachusetts General Hospital
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .