Phase 2 N=50 Treatment

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

Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00438256 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Jan 2019

Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Proton Beam Radiation (Procedure); Capecitabine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm	—	—
PRIMARY Number of Participants With Grade 3 or Greater Toxicity in Phase II	2	—
SECONDARY Number of Participants With a Pathological Complete Response	—	—
SECONDARY Median Progression Free Survival	10.4	—
SECONDARY Number of Participants With Surgical Morbidity	—	—
SECONDARY 30-Day Post Operative Mortality	—	—
SECONDARY Number of Participants With Treatment Related Serious Adverse Events	0; 0; 0; 2	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00438256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.