Carbon Ion or Conventional Photon Radiation Therapy and Chemotherapy in Treating Patients with Locally Advanced, Unresectable Pancreatic Cancer
- All patients must be willing and capable to provide informed consent within the 30 days prior to registration to participate in the protocol
- Histological and/or cytological diagnosis of pancreas adenocarcinoma must be done at any point prior to registration
- Unresectable by radiographic or exploration within 30 days of registration
- Distance from the pancreas tumor edge to the bowel and stomach >= 3 mm
- Tumor does not exceed 15 cm in greatest dimension
- No evidence for metastatic disease as assessed by computed tomography (CT) imaging of the chest, abdomen and pelvis OR by positron emission tomography (PET)-CT within the 30 days prior to registration. Pancreas-protocol CT or magnetic resonance imaging (MRI) with gadolinium (for patients who cannot receive CT contrast) is required as part of this evaluation
- Zubrod performance status of 0-1, within 30 days prior to registration
- Absolute neutrophil count >= 1500 cells/mm^3
- Creatinine < 1.5 mg/dL
- Hemoglobin >= 8.0 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 X upper limit of normal (ULN) (obtained within 14 days prior to registration [may be taken after stent placement])
- Bilirubin =< 1.5 times the ULN (after stent placement, if necessary)
- Patients must complete all required pretreatment evaluations
- Able to travel to a foreign country within approximately 4 weeks of randomization (for patients enrolled outside of Japan and Italy)
- If a patient receives 1 or 2 cycles of chemotherapy at an outside facility, pre-treatment laboratory values must meet the above criteria. If the protocol-compliant imaging had not been obtained prior to chemotherapy, they may be performed prior to registration and any additional chemotherapy being infused
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- 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)
- Subjects receiving other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study
- Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
- Prior radiation to the upper abdomen
- Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy)
- Body weight > 100 kg
- Active inflammatory bowel disease or active gastric/duodenal ulcer
- Metal implants in the upper abdomen
- Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy
- History of human immunodeficiency virus (HIV) or hepatitis B or C
I. To compare the efficacy of carbon ion-based chemoradiotherapy with x-ray-based chemoradiotherapy for the treatment of locally advanced pancreatic adenocarcinoma by comparison of overall survival at 2 years following treatment.
I. To compare progression-free survival between x-ray-based and carbon-ion-based chemoradiotherapy treatment courses for locally advanced pancreatic adenocarcinoma.
II. To compare patterns-of-failure between x-ray-based and carbon-ion-based chemoradiotherapy treatment courses for locally advanced pancreatic adenocarcinoma.
III. To compare quality-of-life and toxicity outcomes between x-ray-based and carbon-ion-based chemoradiotherapy treatment courses for locally advanced pancreatic adenocarcinoma.
I. To compare quality-adjusted survival time between x-ray-based and carbon-ion-based chemoradiotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Within 6 weeks of the conclusion of the last cycle neoadjuvant chemotherapy, patients undergo carbon ion radiation therapy daily 4 days per week for 3 weeks. Patients also receive concurrent gemcitabine intravenously (IV) over 1 hour during weeks 1-3 of radiotherapy. Starting within 6 weeks of completing radiation therapy, patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30 minutes weekly for 3 weeks or FOLFIRINOX. Treatment repeats every 4 weeks for up to 2 (if receiving neoadjuvant chemotherapy) or 4 (if no prior neoadjuvant chemotherapy) cycles in the absence disease progression or unacceptable toxicity. In countries without access to these drugs, gemcitabine alone is acceptable.
ARM B: Within 6 weeks of the conclusion of the last cycle neoadjuvant chemotherapy, patients undergo intensity-modulated radiation therapy 5 days per weeks for 5 weeks. Patients also receive concurrent gemcitabine IV over 1 hour or capecitabine orally (PO) twice daily (BID) during weeks 1-5 of radiotherapy. Starting within 6 weeks of completing radiation therapy, patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30 minutes weekly for 3 weeks or FOLFIRINOX. Treatment repeats every 4 weeks for up to 2 (if receiving neoadjuvant chemotherapy) or 4 (if no prior neoadjuvant chemotherapy) cycles in the absence disease progression or unacceptable toxicity. In countries without access to these drugs, gemcitabine alone is acceptable.
FOLFIRINOX: Patients receive oxaliplatin IV , leucovorin IV, and irinotecan IV on days 1 and 15, and fluorouracil IV over 46 hours on days 1-3 and 15-17.
After completion of study treatment, patients are followed up every 3 months.
Trial Phase Phase III
Trial Type Treatment
UT Southwestern / Simmons Cancer Center-Dallas
David Jonathan Sher
- Primary ID SCCC-05216; STU 022016-002
- Secondary IDs NCI-2019-03055
- Clinicaltrials.gov ID NCT03536182