Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

5 Radiation sessions: 3 in week 1 and 2 in week 2

5 Radiation sessions: 4 in week 1 and 1 in week 2

Given over different schedules and duration

Proton Beam Radiation

Given orally starting on day one of radiation therapy for 2 weeks

Theodore Hong, MD

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.

* 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.

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

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)

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.

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.

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.

Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery

The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy.

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.

Dana-Farber Cancer Institute

National Cancer Institute (NCI)

Massachusetts General Hospital

Attending Radiation Oncologist

Procedure/Surgery:

Proton Beam Radiation: Given over 10 Radiation Sessions over 2 weeks

Drug:

Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks

Proton Beam Radiation/ Capecitabine Dose Level 1

Procedure/Surgery:

Proton Beam Radiation: Given over 5 Radiation sessions: 3 in week 1 and 2 in week 2

Drug:

Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks

Proton Beam Radiation/ Capecitabine Dose Level 2

Procedure/Surgery:

Proton Beam Radiation: Given over 5 Radiation sessions: 4 in week 1 and 1 in week 2

Drug:

Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks

Proton Beam Radiation/ Capecitabine Dose Level 3

Procedure/Surgery:

Proton Beam Radiation: Given over 5 Radiation Sessions in one week

Drug:

Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks

Proton Beam Radiation/ Capecitabine Dose Level 4

Procedure/Surgery:

Proton Beam Radiation: Given over different schedules and duration

Drug:

Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks

Proton Beam Radiation/ Capecitabine

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Carbohydrate antigen (CA) 19-9 is an antigen released by pancreatic cancer cells.

CA19-9 level at baseline

Tumor size on CT

Phase 1 radiation schedule escalation arms were combined with the phase II dose arm to highlight overall trends of the regimen

Procedure/Surgery:

Proton Beam Radiation: 5 fractions over 5 consecutive days for a total of 25 Gray Equivalents (GyE)

Drug:

Capecitabine: Given orally starting on day one of radiation therapy for 2 weeks

The participants treated with radiation therapy at the 5 fractions over 5 consecutive days

Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm

Phase II: Proton Beam Radiation/ Capecitabine

Participants in the Phase II portion of the trial

Number of Participants With Grade 3 or Greater Toxicity in Phase II

The eligible participants who underwent surgical resection. The phase I arms and Phase II group were combined together for analysis.

Number of Participants With a Pathological Complete Response

Two participants were excluded from the analysis because of ineligible final diagnoses (cholangiocarcinoma and autoimmune pancreatitis)

Median Progression Free Survival

The eligible participants who underwent surgical resections. The phase I arms and Phase II group were combined together for analysis.

Spots Global Cancer Trial Database for accelerated short course