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Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01494155
Recruitment Status : Active, not recruiting
First Posted : December 16, 2011
Last Update Posted : April 9, 2020
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Brief Summary:

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

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : October 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Hydroxychloroquine
Hydroxychloroquine with chemoradiation
Drug: Capecitabine
825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)
Other Name: Xeloda

Drug: Hydroxychloroquine
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Overall survival [ Time Frame: 2 years ]
    To determine overall survival in patients treated with preoperative capecitabine + hydroxychloroquine and short course radiation therapy

  3. 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

  4. 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

  5. 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

  6. Biomarkers [ Time Frame: 2 years ]
    To explore biomarkers of autophagy with hydroxychloroquine therapy and explore correlation with progression-free survival

  7. 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)

  8. Local control [ Time Frame: 2 years ]
    To determine local tumor control at 2 years post treatment in study participants

  9. Describe QoL [ Time Frame: 2 Years ]
    To describe quality of life, symptom burden and mood in the study population

  10. Measure utilization of health services [ Time Frame: 2 years ]
    Measure utilization of health services (ER, hospital and ICU visits) in the study population

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 syndrome
  • 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 deficiency
  • 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 disability
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01494155

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Theodore S Hong, MD Massachusetts General Hospital
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Responsible Party: Theodore Sunki Hong, Radiation Oncologist, Massachusetts General Hospital Identifier: NCT01494155    
Other Study ID Numbers: 11-073
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Keywords provided by Theodore Sunki Hong, Massachusetts General Hospital:
resectable pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Antirheumatic Agents