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

Phase 2

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Radiation: Proton Radiation; Drug: Capecitabine; Procedure: Surgical resection

• Registration Number: NCT02598349
• Lead Sponsor: Proton Collaborative Group

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Study Start: 2016-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2039-10
• Study Completion: 2040-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton Radiation with capecitabine	Proton Radiation	The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
Proton Radiation with capecitabine	Surgical resection	The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
Proton Radiation with capecitabine	Capecitabine	The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.

Primary Outcome Measures

Name	Time	Method
Overall survival at 12 months after radiation therapy	Approximately 12 months after radiation therapy.	The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%.

Secondary Outcome Measures

Name	Time	Method
Surgical resection rate.	3 months following the completion of radiation therapy.	Increase share of marginally resectable and unresectable patients being converted to resectable.

Trial Locations

Locations (4)

Northwestern Medicine Chicago Proton Center; 🇺🇸 Warrenville, Illinois, United States

McLaren Proton Therapy Center; 🇺🇸 Flint, Michigan, United States

Inova Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States