Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

* 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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm [3 Weeks]. Count Of Participants, Participants. Proton Beam Radiation/ Capecitabine (n=6): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Grade 3 or Greater Toxicity in Phase II [30 days after the end of treatment, up to approximately 6 months total]. Count Of Participants, Participants. Phase II: Proton Beam Radiation/ Capecitabine (n=35): 2.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With a Pathological Complete Response [at the time of surgery (28-42 days after start of treatment)]. Count Of Participants, Participants. Proton Beam Radiation/ Capecitabine (n=37): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Median Progression Free Survival [from the start of treatment until death or progression, median duration of 10.4 months]. Median, Months (95% Confidence Interval). Proton Beam Radiation/ Capecitabine (n=48): 10.4 (7.5 to 17.1).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Surgical Morbidity [30 days post surgery (surgery was 28-42 days after the start of treatment)]. Count Of Participants, Participants. Proton Beam Radiation/ Capecitabine (n=37): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

30-Day Post Operative Mortality [30 days after the time of surgery (Surgery is 28-42 days after start of treatment)]. Count Of Participants, Participants. Proton Beam Radiation/ Capecitabine (n=37): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Treatment Related Serious Adverse Events [From the start of treatment until 30 days after the end of treatment, up to approximately 5 months]. Count Of Participants, Participants. Proton Beam Radiation/ Capecitabine Dose Level 1 (n=3): 0; Proton Beam Radiation/ Capecitabine Dose Level 2 (n=3): 0; Proton Beam Radiation/ Capecitabine Dose Level 3 (n=3): 0; Proton Beam Radiation/ Capecitabine Dose Level 4 (n=41): 2.