Trial of Carbon Ion Versus Photon Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 103
• Participant gender: All

Summary

To determine if carbon ion radiotherapy improves overall survival versus photon therapy in patients with locally advanced, unresectable pancreatic cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. All patients must be willing and capable to provide informed consent within the 30 days prior to registration to participate in the protocol.

2. Histological and/or cytological diagnosis of pancreas adenocarcinoma must be done at any point prior to registration

3. Unresectable by radiographic or exploration within 30 days of registration

4. Age ≥ 18 years.

5. Distance from the pancreas tumor edge to the bowel and stomach > 3 mm (in both the prone and supine positions)

6. Tumor does not exceed 15 cm in greatest dimension

7. No evidence for metastatic disease as assessed by CT imaging of the chest, abdomen and pelvis OR by PET-CT within the 30 days prior to registration.

8. Zubrod performance status of 0-1, within 30 days prior to registration.

9. CMP and CBC with differential obtained within 14 days prior to registration (may be taken after stent placement), with adequate hematologic variables as defined by:

Absolute neutrophil count > 1500 cells/mm3 Creatinine <1.5 mg/dL Hemoglobin >8.0 g/dL AST and ALT < 2.5 X ULN Bilirubin < 1.5 times the ULN (after stent placement, if necessary)

10. Patients must complete all required pretreatment evaluations

11. Able to travel to a foreign country within approximately 2 weeks of randomization (for patients enrolled at UTSW)?

12. Women of childbearing potential and male participants must agree to use an effective method of contraception.

A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy; or

• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

1. Subjects receiving other investigational agents.

2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study.

3. Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

4. Prior treatment for pancreatic cancer preceding registration

5. Prior radiation to the upper abdomen

6. Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).

7. Body weight >100 kg

8. Active inflammatory bowel disease or active gastric/duodenal ulcer

9. Metal implants in the upper abdomen

10. Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy.

11. History of HIV or hepatitis B or C