Clinical trialPhase 2Completed
Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 27 December 2011
- Expected end
- 16 September 2018
- Enrollment
- 50 participants
- Sites
- 1
- Primary outcomes
- Progression-free Survival
- Sponsor
- Other
- Results posted
- 2026-08-05
- Last update
- 5 August 2026
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Brief summary public domain (ClinicalTrials.gov)
A standard treatment for patients with pancreatic cancer is standard photon radiation in combination with the chemotherapy drug, capecitabine. In this research study the investigators are using standard photon radiation or a different type of radiation therapy called proton beam radiation and adding hydroxychloroquine to be used in combination with capecitabine. In this research study, the investigators are looking to determine if proton or photon beam radiation in combination with hydroxychloroquine and capecitabine is effective in controlling your cancer growth.
Detailed description public domain (ClinicalTrials.gov)
Subjects will be treated in cycles of 28 days. Hydroxychloroquine will be taken orally, daily until the day before surgery and will resume after surgery until study end. Capecitabine will be taken orally, daily. Proton or photon radiation treatment will start on Week 2 and will be delivered daily (5 days in a row, but not weekends or holidays). Radiation treatment will be give on an outpatient basis at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at Massachusetts General Hospital. The following tests will be performed weekly: physical exam, routine blood tests, optional blood tests and an eye exam every 3 months while taking hydroxychloroquine. Subjects will have surgery (any time between Weeks 5 to 9) and after surgery resume taking hydroxychloroquine. Subjects will have a follow up visit every 3 months which will include: physical exam, routine blood tests, eye exam, and tumor assessment by chest and abdominal-pelvic CT scan or MRI (every 6 months for the first 2 years and yearly for years 3-5).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [up to 4 years]. Count Of Participants, Participants. 2-year PFS: Hydroxychloroquine (n=50): 16. 4-year PFS: Hydroxychloroquine (n=50): 10.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Pathologic Complete Response [up to 9 weeks]. Count Of Participants, Participants. Hydroxychloroquine (n=50): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [up to 4 years]. Count Of Participants, Participants. 2-year OS: Hydroxychloroquine (n=50): 21. 4-year OS: Hydroxychloroquine (n=50): 12.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Treatment-Emergent Adverse Events [3 weeks]. Count Of Participants, Participants. Vomiting: Hydroxychloroquine (n=50): 1. Nausea: Hydroxychloroquine (n=50): 1. Hyperglycemia: Hydroxychloroquine (n=50): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Surgical Morbidity [up to 30 days after surgery]. Count Of Participants, Participants. Hydroxychloroquine (n=47): 6.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Post-operative Mortality [30 days after surgery]. Count Of Participants, Participants. Hydroxychloroquine (n=47): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Pathologic Downstaging [up to 9 weeks]. Count Of Participants, Participants. Hydroxychloroquine (n=47): 47.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Local Control [Up to 2 years]. Count Of Participants, Participants. Hydroxychloroquine (n=50): 43.