deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 4-arm NCT00438256

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

Updated 8 times since 2017 Last updated: Dec 31, 2018 Started: Dec 31, 2007 Primary completion: Dec 31, 2017 Completion: Dec 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Jan 2018 · 12 months · monthly snapshotActive Not Recruiting~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshotCompleted~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotCompleted~Jul 2018 – ~Feb 2019 · 7 months · monthly snapshotCompleted~Feb 2019 – ~Jan 2021 · 23 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Feb 2019 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  5. Jul 2018 — Feb 2019 [monthly]

    Completed PHASE1_PHASE2

Show 3 earlier versions
  1. Jun 2018 — Jul 2018 [monthly]

    Completed PHASE1_PHASE2

  2. Jan 2018 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

  3. 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

Sponsor contact:
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • National Cancer Institute (NCI)
Data source: Massachusetts General Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations