Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT01494155|
Recruitment Status : Active, not recruiting
First Posted : December 16, 2011
Last Update Posted : April 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Capecitabine Drug: Hydroxychloroquine Radiation: Proton or Photon Radiation Therapy||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||January 2020|
Hydroxychloroquine with chemoradiation
825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)
Other Name: Xeloda
400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital
Other Name: Plaquenil
Radiation: Proton or Photon Radiation Therapy
Daily, beginning Week 2 for 5 consecutive days
- Progression-free survival [ Time Frame: 2 years ]To determine the progression-free survival of the addition of hydroxychloroquine to preoperative short course, chemoradiation therapy and adjuvant gemcitabine chemotherapy
- Pathologic response rate [ Time Frame: 2 years ]To determine the complete pathologic response rate of preoperative capecitabine combined with hydroxychloroquine and short course radiation therapy in patients undergoing pancreaticoduodenectomy
- Overall survival [ Time Frame: 2 years ]To determine overall survival in patients treated with preoperative capecitabine + hydroxychloroquine and short course radiation therapy
- Toxicity/Adverse events [ Time Frame: 2 years ]To determine the toxicity of capecitabine + hydroxychloroquine and short course radiation therapy in patients with pancreatic cancer via analysis of frequency and grades of reported toxicities and adverse events, such as GI and hematologic toxicities, occurring in study participants
- Surgical morbidity [ Time Frame: 2 years ]To determine the surgical morbidity in patients undergoing pancreaticoduodenectomy who received preoperative capecitabine + hydroxychloroquine and external beam radiation therapy
- Post-operative Mortality [ Time Frame: 2 weeks ]To determine 30-day post-operative mortality after pancreaticoduodenectomy in patients who receive preoperative capecitabine and external beam radiation therapy
- Biomarkers [ Time Frame: 2 years ]To explore biomarkers of autophagy with hydroxychloroquine therapy and explore correlation with progression-free survival
- Pathologic down-staging [ Time Frame: 2 years ]To determine pathologic down-staging of hydroxychloroquine-based short course chemoradiation compared to a previous cohort (treated in prior study of neoadjuvant capecitabine + proton therapy)
- Local control [ Time Frame: 2 years ]To determine local tumor control at 2 years post treatment in study participants
- Describe QoL [ Time Frame: 2 Years ]To describe quality of life, symptom burden and mood in the study population
- Measure utilization of health services [ Time Frame: 2 years ]Measure utilization of health services (ER, hospital and ICU visits) in the study population
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494155
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Theodore S Hong, MD||Massachusetts General Hospital|