Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04975516

Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for Oligometastatic Pancreatic Cancer

Metastatic Pancreatic Adenocarcinoma Clinical Trial

Official title:
Phase 2 Randomized Trial of Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for the Treatment of Oligometastatic Pancreatic Adenocarcinoma

Clinical Trial Summary

This phase II trial studies the effect of standard of care chemotherapy with or with out stereotactic body radiation therapy in treating patients with pancreatic cancer that has spread to a limited amount of places in the body (oligometastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with stereotactic body radiation therapy may help improve tumor control, decrease risk of tumor spreading more, decrease side effects, and prolong survival.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Compare progression free survival (PFS) between stereotactic body radiation therapy (SBRT) + standard chemotherapy versus (vs.) standard chemotherapy alone in patients with oligometastatic pancreatic cancer. SECONDARY OBJECTIVES: I. Confirmed response rate. II. Overall survival. III. Adverse events. IV. Longitudinal assessment of circulating tumor cells (CTC) and circulating tumor deoxyribonucleic acid (ctDNA). CORRELATIVE RESEARCH OBJECTIVE: I. To evaluate fatigue, and other patient-reported outcomes. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo SBRT once daily (QD) or every other day for 5 fractions, and receive chemotherapy per standard of care. GROUP II: Patients receive chemotherapy per standard of care. After completion of study treatment, patients are followed up at 7 and 14 days, and then every 8-12 weeks for 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04975516
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 2
Start date July 18, 2023
Completion date July 2, 2027
View Details
See also
  Status Clinical Trial Phase
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT01964287 - First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma. Phase 1/Phase 2
Completed NCT02826486 - Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202) Phase 2
Active, not recruiting NCT04524702 - Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT02890355 - FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer Phase 2
Recruiting NCT04652206 - Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients. Phase 1/Phase 2
Recruiting NCT04132505 - Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer Phase 1
Completed NCT00998322 - A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma Phase 2
Active, not recruiting NCT04514497 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer Phase 1
Completed NCT02562898 - Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer Phase 1/Phase 2
Recruiting NCT05642962 - Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) Phase 1/Phase 2
Completed NCT01896869 - FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer Phase 2
Active, not recruiting NCT03337087 - Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer Phase 1/Phase 2
Completed NCT02677038 - Olaparib in Treating Patients With Stage IV Pancreatic Cancer Phase 2
Active, not recruiting NCT02985125 - LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy Phase 1/Phase 2
Recruiting NCT05383352 - A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas Phase 1
Completed NCT03943667 - Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma Phase 3
Completed NCT02436668 - Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE) Phase 3
Completed NCT01360853 - Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer Phase 3
Completed NCT01124786 - A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP) Phase 2