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Trial record 1 of 1 for:    NCT00889187
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Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

This study has been terminated.
(Excess toxicity was identified intraoperatively)
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Harvey Mamon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00889187
First received: April 27, 2009
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

The purpose of this research study is to determine if it is possible to deliver high dose radiation in one week while also giving the drug capecitabine for the treatment of pancreatic cancer prior to surgery, to determine if this treatment can be given safely for the treatment of pancreatic cancer prior to surgery and, to determine if this treatment can improve the local control pancreatic cancer prior to surgery compared to historical controls of standard treatment.


Condition Intervention Phase
Pancreatic Cancer
Radiation: Accelerated Short Course Radiation
Drug: Capecitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Phase I: To determine the feasibility and tolerability of radiation therapy for pancreatic cancer delivered with high dose external beam radiation in a one week accelerated schedule. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Phase II: To demonstrate a grade 3 or greater (any) toxicity rate of less than 20% [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine local control and recurrence patterns of pancreatic cancer relative to a standard regimen of 50.4 Gy as seen in historical controls. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the pathologic response rate of preoperative capecitabine and high dose radiation therapy in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the progression-free survival in patients treated with preoperative capecitabine and photon beam radiation therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine 30-day post-operative mortality after pancreatic resection in patients who receive this protocol treatment. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: August 2009
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Accelerated Short Course Radiation
    Beginning on a weekday for 7 to 12 days
    Drug: Capecitabine
    Twice a day for 10 consecutive weekdays while receiving radiation therapy
Detailed Description:
  • Since we are looking for the best schedule and dose of radiation that can be administered safely without severe or unmanageable side effects in participants with pancreatic cancer, not everyone who participates in this research study will receive the same dose of radiation therapy. The dose participants will get will depend upon the number of participants enrolled in the study and how well they have tolerated their doses.
  • Radiation treatment days will begin on a weekday and continue for a total of 7 to 12 days. Capecitabine pills will begin on the morning of the first day of radiation and be taken twice a day for 10 consecutive weekdays, while the participant is receiving radiation.
  • Blood tests, vital signs and a physical exam will be performed on day 1 and day 15 and either days 7, 8, or 9.
  • Surgery will be performed 1 to 3 weeks after completion of radiation and capecitabine.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to treatment.
  • No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI with gadolinium and/or manganese), and all patients must be staged with a physical exam, chest CT, and abdominal CT with intravenous contrast.
  • Only potentially resectable patients are eligible. Potentially resectable is defined as: a)no extrapancreatic disease, b)no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, and c)no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
  • 18 years of age or older
  • ECOG Performance status of 0 or 1
  • Women of child bearing potential must practice adequate contraception and to refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
  • Lab values as specified in the protocol

Exclusion Criteria:

  • Patients cannot have hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation
  • Serious concomitant systemic disorders incompatible with the study, such as significant cardiac or pulmonary morbidity, or ongoing infection as manifested by fever
  • Pregnant or lactating women
  • Life expectancy < 3 months
  • Serious, uncontrolled, concurrent infection(s)
  • Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
  • Treatment for other cancers within the last five years, except cured non-melanoma skin cancer and treated in situ cervical cancer
  • Clinically significant cardiac disease or myocardial infarction within the last 12 months
  • Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • Known, existing uncontrolled coagulopathy
  • Unwillingness to participate or inability to comply with the protocol for the duration of the study
  • Any prior 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 judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake
  • Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
  • Patients should not be on cimetidine as it can decrease the clearance of 5-FU. Another H2-blocker or proton pump inhibitor may be substituted before study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889187

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Harvey Mamon, MD, PhD Brigham and Women's Hospital/Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Harvey Mamon, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00889187     History of Changes
Other Study ID Numbers: 08-375
Study First Received: April 27, 2009
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
radiation therapy
capecitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014