mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy

Trial Title: mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy

NCT ID: NCT06249321

Condition: Pancreatic Cancer
Radiotherapy

Conditions: Official terms:
Pancreatic Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: mFOLFIRINOX plus IMRT
Description: Chemotherapy will be administered according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline and a modified FOLFIRINOX regimen will be the first choice. Patients with advanced pancreatic adenocarcinoma will receive the modified FOLFIRINOX regimen (oxaliplatin [70 mg per square meter of body surface area], irinotecan [130 mg per square meter], leucovorin [200 mg per square meter], and fluorouracil [2000 mg per square meter] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy. The following treatment after radiotherapy will be applied according to the newest edition of NCCN guideline.
Arm group label: mFOLFIRINOX plus radiotherapy

Summary: The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer refractory to chemotherapy.

Detailed description: Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. Carbohydrate antigen 19-9 (CA19-9) is the most widely used biomarker in pancreatic cancer. Circulating CA19-9 levels are positively correlated with tumor burden and stage in pancreatic cancer with a diagnostic sensitivity of approximately 80%, suggesting that approximately 20% of patients have normal CA19-9 levels. It is well recognized that Lewis (-) individuals, constituting approximately 10% of the population, have low or no secretion of CA19-9 due to the lack of critical enzyme involved in CA19-9 biosynthesis. Thus, approximately 10% of patients with pancreatic cancer have normal CA19-9 levels regardless of tumor stage. Our previously retrospective study has shown that CA19-9-normal advanced pancreatic cancer may be more sensitive to chemotherapy combined with radiotherapy. The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to patients with CA19-9-normal advanced pancreatic cancer who are refractory to chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every four weeks.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Ability to understand and the willingness to sign a written informed consent document. - Age ≥ 18 years and ≤ 80 years. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2. - Histologically or cytologically confirmed advanced pancreas adenocarcinoma. - Patients who are refractory to at least one line of chemotherapy and who have not received radiotherapy. - Locally advanced or distant metastatic pancreatic cancer. - Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL. - Presence of at least of one measurable lesion in agreement to RECIST criteria. - The expected survival ≥ 3 months. - Adequate organ performance based on laboratory blood tests. - Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: - Pregnant or nursing women. - Primary pancreatic cancer. - Baseline serum CA19-9 > 37 U/mL, CEA > 5.2 ng/mL, or CA125 > 35 U/mL. - The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. - Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. - Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results. - Renal insufficiency or dialysis - Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. - Patients who are allergic to oxaplatin or other chemotherapy drugs. - Patients who are unwilling or unable to comply with study procedures.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Ying Yang, MD

Phone: 86 21 64175590

Phone ext: 1307
Email: yangying@fudanpci.org

Investigator:
Last name: Guopei Luo, MD
Email: Principal Investigator

Start date: April 1, 2024

Completion date: March 1, 2028

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06249321