Radiotherapy To Patients With CA19-9-elevated Advanced Pancreatic Cancer

Study Overview

Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer

The purpose of this study is to evaluate the efficacy of chemotherapy plus radiotherapy to patients with CA19-9-elevated Advanced Pancreatic Cancer who are not refractory to chemotherapy.

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 chemotherapy plus radiotherapy to patients with CA19-9-elevated Advanced Pancreatic Cancer who are not refractory to chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every four weeks.

Pancreatic Adenocarcinoma

DRUG: Gemcitabine, Nab-paclitaxel, Irinotecan
RADIATION: Intensity-Modulated Radiation Therapy (IMRT)

PTCA199-11

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-01-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-22
First Submitted that Met QC Criteria 2024-02-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-23
First Posted (ACTUAL) 2024-02-09	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: chemotherapy Continuing chemotherapy using the previous regimen	DRUG: Gemcitabine, Nab-paclitaxel, Irinotecan continuing chemotherapy using the previous regimen until disease progression RADIATION: Intensity-Modulated Radiation Therapy (IMRT) Receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy.
EXPERIMENTAL: Radiotherapy Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy. Other radiation therapies include stereotactic body radiotherapy (SBRT) and proton could be administered.	RADIATION: Intensity-Modulated Radiation Therapy (IMRT) Receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: chemotherapy

Continuing chemotherapy using the previous regimen

DRUG: Gemcitabine, Nab-paclitaxel, Irinotecan

continuing chemotherapy using the previous regimen until disease progression

RADIATION: Intensity-Modulated Radiation Therapy (IMRT)

Receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy.

EXPERIMENTAL: Radiotherapy

Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy. Other radiation therapies include stereotactic body radiotherapy (SBRT) and proton could be administered.

RADIATION: Intensity-Modulated Radiation Therapy (IMRT)

Receive Intensity-Modulated Radiation Therapy (IMRT) after about 2~6 cycles of chemotherapy.

Primary Outcome Measures	Measure Description	Time Frame
progression-free survival, PFS	PFS of subjects from recruiting to the time of disease progression	At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival，OS	OS of subjects from recruiting to the time of death from any cause	At the end of Cycle 1 (each cycle is 28 days)
objective response rate (ORR)	CR + PR	At the end of Cycle 1 (each cycle is 28 days)
disease control rate (DCR)	CR + PR + SD	At the end of Cycle 1 (each cycle is 28 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ying Yang, MD

Phone Number: 86 64175590

Email: yangying@fudanpci.org

Study Contact Backup

Name: Guopei Luo, MD

Phone Number:

Email: luoguopei@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 not refractory to previous chemotherapy and who have not received radiotherapy.
Locally advanced pancreatic cancer.
Baseline serum CA19-9 > 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .
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.

Pregnant or nursing women.
Primary pancreatic cancer.
Baseline serum CA19-9 ≤ 37 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Guopei Luo, MD, Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Zhu X, Xiao Z, Liu H, Zhang P, Deng S, Ding L, Feng J, Luo J, Ni Q, Luo G, Yu X. Pancreatic Cancer: An Exocrine Tumor With Endocrine Characteristics. Ann Surg. 2024 Dec 1;280(6):e17-e25. doi: 10.1097/SLA.0000000000006168. Epub 2023 Dec 5.
Luo G, Jin K, Deng S, Cheng H, Fan Z, Gong Y, Qian Y, Huang Q, Ni Q, Liu C, Yu X. Roles of CA19-9 in pancreatic cancer: Biomarker, predictor and promoter. Biochim Biophys Acta Rev Cancer. 2021 Apr;1875(2):188409. doi: 10.1016/j.bbcan.2020.188409. Epub 2020 Aug 19.
Luo G, Liu C, Guo M, Long J, Liu Z, Xiao Z, Jin K, Cheng H, Lu Y, Ni Q, Yu X. CA19-9-Low&Lewis (+) pancreatic cancer: A unique subtype. Cancer Lett. 2017 Jan 28;385:46-50. doi: 10.1016/j.canlet.2016.10.046. Epub 2016 Nov 10.

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