Proton Radiation for Unresectable Borderline Resectable or Medically Inoperable Carcinoma of the Pancreas

  • STATUS
    Recruiting
  • End date
    Oct 23, 2040
  • participants needed
    60
  • sponsor
    Proton Collaborative Group
Updated on 23 January 2021
platelet count
drainage
carcinoma
obstruction
pancreatic adenocarcinoma
capecitabine
cancer chemotherapy
adenocarcinoma
biliary obstruction

Summary

The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).

Description

Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days.

In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.

Quality of Life questionnaires are a part of this study.The Fact-Hep questionnaires will be filled out by the participant at strategic time points in the treatment course.

Details
Condition Pancreatic Cancer, Pancreatic disorder, Neoplasm of unspecified nature of digestive system, Pancreatic Disorders, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Capecitabine, Surgical Resection, Proton Radiation, FACT-Hep questionnaire
Clinical Study IdentifierNCT02598349
SponsorProton Collaborative Group
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Pancreatic Cancer?
Do you have any of these conditions: Pancreatic Disorders or pancreatic cancers or Digestive System Neoplasms or Neoplasm of unspecified nature of digestive system or Pancreatic disorder ...?
Biopsy proven unresectable adenocarcinoma of the pancreas
Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery
A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation
Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter
Required pretreatment laboratory parameters
Absolute granulocyte count (AGC/ANC) 1.8 thou/mm3
Platelet count 100,000/mm3
Bilirubin < 2 mg/dl
ALT/SGPT < 3x upper limit of normal
Creatinine < 3 mg/dl

Exclusion Criteria

Evidence of distant metastasis
Prior surgical resection
Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration
Active or untreated infection
Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter
Previous Radiation to the abdomen
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