Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine 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.
 
ClinicalTrials.gov Identifier: NCT00438256
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Proton Beam Radiation Drug: Capecitabine Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm [ Time Frame: 3 Weeks ]

    The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included:

    1. Any grade 3 non-hematologic or hematologic toxicity requiring a greater than 7 day interruption in therapy (excluding alopecia and nausea/vomiting not controlled by optimal supportive care or
    2. Any grade 4 non-hematologic toxicity or
    3. Any grade 4 neutropenia or thrombocytopenia as defined by Common Terminology Criteria for Adverse Events (CTCAE v3.0)

  2. Number of Participants With Grade 3 or Greater Toxicity in Phase II [ Time Frame: 30 days after the end of treatment, up to approximately 6 months total ]
    Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity.


Secondary Outcome Measures :
  1. Number of Participants With a Pathological Complete Response [ Time Frame: at the time of surgery (28-42 days after start of treatment) ]
    All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen.

  2. Median Progression Free Survival [ Time Frame: from the start of treatment until death or progression, median duration of 10.4 months ]

    The median amount of time from the start of treatment until death or disease progression, whichever occurs first.

    Progressive Disease (PD): A 20% or greater increase in the sum of Longest Diameter (LD) of all target lesions, taking as reference the smallest sum LD recorded since baseline.


  3. Number of Participants With Surgical Morbidity [ Time Frame: 30 days post surgery (surgery was 28-42 days after the start of treatment) ]
    Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery

  4. 30-Day Post Operative Mortality [ Time Frame: 30 days after the time of surgery (Surgery is 28-42 days after start of treatment) ]
    The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy.

  5. Number of Participants With Treatment Related Serious Adverse Events [ Time Frame: From the start of treatment until 30 days after the end of treatment, up to approximately 5 months ]
    The number of participants that had treatment related serious adverse events. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). Adverse events were considered to be serious adverse events if they were grade 3 or greater and were considered to be possibly, probably, or definitely related to treatment.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00438256


Locations
Layout table for location information
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
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Theodore Hong, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Theodore Sunki Hong, Massachusetts General Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Theodore Sunki Hong, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438256     History of Changes
Other Study ID Numbers: 06-248
First Posted: February 22, 2007    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019
Last Verified: December 2018
Keywords provided by Theodore Sunki Hong, Massachusetts General Hospital:
accelerated short course
proton beam radiation
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents