Trial record 1 of 1 for:    NCT00438256
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Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438256
First received: February 20, 2007
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous research has suggested that giving the radiation and chemotherapy for a shorter amount of time (accelerated schedule) before surgery may be better tolerated. In this research study, different schedules of proton radiation therapy will be used. Each schedule will give about the same total dose of radiation. However, the total dose will be spread out over different time periods and different numbers of sessions. The purpose is to find the shortest schedule of radiation therapy that can be given without unacceptable side effects. Proton beam radiation is being used because of its unique ability to deposit its energy directly in the tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being studied to see if it can help predict the response to pre-surgery treatment.


Condition Intervention Phase
Pancreatic Cancer
Procedure: Proton Beam 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 of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the feasibility and tolerability of radiation therapy delivered with proton beam in a one week accelerated schedule with concurrent capecitabine for pancreatic cancer. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To demonstrate a grade 3 or greater (any) toxicity rate of less than 20% [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • to determine the complete pathologic response rate of preoperative capecitabine and proton beam radiation therapy in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: December 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
10 Radiation Sessions over 2 weeks
Procedure: Proton Beam Radiation
Given over different schedules and duration
Drug: Capecitabine
Given orally starting on day one of radiation therapy for 2 weeks
Experimental: Group 2
5 Radiation sessions: 3 in week 1 and 2 in week 2
Procedure: Proton Beam Radiation
Given over different schedules and duration
Drug: Capecitabine
Given orally starting on day one of radiation therapy for 2 weeks
Experimental: Group 3
5 Radiation sessions: 4 in week 1 and 1 in week 2
Procedure: Proton Beam Radiation
Given over different schedules and duration
Drug: Capecitabine
Given orally starting on day one of radiation therapy for 2 weeks
Experimental: Group 4
5 Radiation Sessions in one week
Procedure: Proton Beam Radiation
Given over different schedules and duration
Drug: Capecitabine
Given orally starting on day one of radiation therapy for 2 weeks

Detailed Description:
  • Not everyone who participates in this research study will receive the same schedule of radiation therapy. The schedule of radiation therapy will depend on the number of participants enrolled on the study and how well they have tolerated their radiation schedule. All patients will receive proton beam therapy.
  • Here are the proposed schedules of radiation therapy. If at any point too many subjects experience too many unacceptable side effects, no subject will be enrolled to the next level. Dose Level 1: 10 radiation sessions given Monday-Friday for two weeks. Dose Level 2: 5 radiation sessions given Monday, Wednesday and Friday in Week 1 and Tuesday and Thursday in Week 2. Dose Level 3: 5 radiation sessions given Monday, Tuesday, Thursday and Friday in Week 1 and Monday in Week 2. Dose Level 4: 5 Radiation sessions given Monday through Friday in Week 1.
  • In Dose Levels 2, 3 and 4, there are fewer radiation sessions, but the radiation dose given at each session is slightly higher than the dose given in each of the 10 sessions of Dose Level 1.
  • Capecitabine will be given orally (pill form) starting on the first day of radiation therapy and will be taken for the two weeks that the participant receives radiation therapy.
  • On days 1, 8 and 15 of each study cycle, the participant will be seen at the clinic for: physical examination, questions about side effects; and routine blood tests.
  • After the last day of study treatment there will be up to a six-week rest period before surgery is performed.
  • About three to six weeks after the participant has finished study treatment, the following procedures will be done: CT or MRI, physical examination; questions about side effects and blood tests.
  Eligibility

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

Inclusion Criteria:

  • Cytologic of histologic proof of pancreatic ductal carcinoma
  • No evidence of metastatic disease
  • 18 years of age or older
  • ECOG Performance Status of 0 or 1 - Lab values as outlined in the protocol

Exclusion Criteria:

  • Tumors in the body or tail of the pancreas
  • 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, ongoing infection as manifested by fever
  • Pregnant or lactating women
  • Life expectancy of < 3 months
  • Serious, uncontrolled, concurrent infection (s)
  • Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
  • Clinically significant cardiac disease or myocardial infarction within the last 12 months
  • Other serious uncontrolled medical condition that the investigator feels might compromise study participation
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • Known, existing uncontrolled coagulopathy
  • Any prior fluoropyrimidine therapy
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to a 5-fluorouracil or known DPD deficiency
  • Participation in any investigational drug study within 4 weeks preceding the start of the study
  • 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
  • Patients on cimetidine
  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: NCT00438256

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Theodore Hong, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theodore Sunki Hong, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438256     History of Changes
Other Study ID Numbers: 06-248
Study First Received: February 20, 2007
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
accelerated short course
proton beam radiation

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
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014