Know Cancer

forgot password

Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

Thank you

Trial Information

Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

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 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 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

Inclusion Criteria:

- Cytologic or histologic proof of pancreatic ductal carcinoma

- Life expectancy > 3 months

- Adequate organ and marrow function

Exclusion Criteria:

- Evidence of metastatic disease

- Pregnant or breast-feeding

- Tumors in the body or tail of the pancreas

- Serious concomitant systemic disorders such as significant cardiac or pulmonary
morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and
cardiac arrhythmias not well controlled with medication) or myocardial infarction
within the last 12 months, ongoing infection as manifest by fever

- Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor

- Diagnosis of other invasive carcinomas (except basal cell carcinomas/squamous cell
carcinoma of the skin) with the last 5 years. Carcinoma in-situ is allowed.

- Other serious uncontrolled medical conditions

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- Known, existing uncontrolled coagulopathy

- Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and
completed at least 6 months earlier). Prior unanticipated severe reaction to
fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known DPD

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment

- History of uncontrolled seizures, central nervous system disorders, or psychiatric

- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,
without complete recovery

- Currently taking cimetidine

- Receiving any other study agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to capecitabine and HCQ

- Already taking HCQ or chloroquine for other diagnosis

- History of Grade 3 or greater retinopathy or keratitis

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

To determine the progression-free survival of the addition of hydroxychloroquine to preoperative short course, proton-based chemoradiation therapy and adjuvant gemcitabine chemotherapy

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Theodore S Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • resectable pancreatic cancer
  • pancreaticoduodenectomy
  • Pancreatic Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617