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Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Theodore Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

06-248

NCT ID:

NCT00438256

Start Date:

December 2007

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • accelerated short course
  • proton beam radiation
  • Pancreatic Neoplasms

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617