- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438256
Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer
Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02215
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
10 Radiation Sessions over 2 weeks
|
Given over different schedules and duration
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
|
Given over different schedules and duration
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
|
Given over different schedules and duration
Given orally starting on day one of radiation therapy for 2 weeks
|
Experimental: Group 4
5 Radiation Sessions in one week
|
Given over different schedules and duration
Given orally starting on day one of radiation therapy for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
3 Weeks
|
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.
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30 days after the end of treatment, up to approximately 6 months total
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at the time of surgery (28-42 days after start of treatment)
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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. |
from the start of treatment until death or progression, median duration of 10.4 months
|
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
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30 days post surgery (surgery was 28-42 days after the start of treatment)
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30-Day Post Operative Mortality
Time Frame: 30 days after the time of surgery (Surgery is 28-42 days after start of treatment)
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The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy.
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30 days after the time of surgery (Surgery is 28-42 days after start of treatment)
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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
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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.
|
From the start of treatment until 30 days after the end of treatment, up to approximately 5 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Theodore Hong, MD, Massachusetts General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- 06-248
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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