Adjuvant Chemoradiation Following Radical Resection Of Pancreatic Ductal Adenocarcinoma, A Prospective Cohort Study

Study Overview

Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study

This is a prospective observation cohort study to evaluate efficacy of different types of adjuvant therapy strategies, including chemoradiotherapy, chemotherapy alone, or no adjuvant treatment, for pancreatic ductal adenocarcinoma patients who received surgical resection of primary cancer.

N/A

Resectable Pancreatic Cancer
Adjuvant Chemoradiotherapy
Surgery

OTHER: Follow-up only
DRUG: Adjuvant chemotherapy
RADIATION: Adjuvant chemoradiotherapy
RADIATION: Adjuvant chemoradiotherapy + Adjuvant chemotherapy

A-RPC

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 2021-01-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-02-01
First Submitted that Met QC Criteria 2021-02-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-04
First Posted (ACTUAL) 2021-02-04	Results First Posted N/A	Last Verified 2021-02

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:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: No adjuvant treatment Pancreatic cancer patients who received surgery without subsequent adjuvant treatment.	OTHER: Follow-up only Only routine follow-up but no treatment
: Adjuvant chemotherapy Pancreatic cancer patients who received surgery and only adjuvant chemotherapy.	DRUG: Adjuvant chemotherapy Chemotherapy regimens will be decided by physicians or MDT teams, basing on patients' physical status, income status, and/or desire. Toxicity was evaluated every cycle and efficacy was evaluated every two cycles. The treatment course of adjuvant chem RADIATION: Adjuvant chemoradiotherapy + Adjuvant chemotherapy See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).
: Adjuvant chemoradiotherapy Pancreatic cancer patients who received surgery and only adjuvant chemoradiotherapy.	RADIATION: Adjuvant chemoradiotherapy Adjuvant CRT could be delivered before or simultaneously with adjuvant chemotherapy. Radiation used 6 MV or 15 MVX-ray beams delivering daily fractions of 180-200cGy to a total dose of 45-55Gy in 25-28 fractions using CT-based, three-dimensional conformal RADIATION: Adjuvant chemoradiotherapy + Adjuvant chemotherapy See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).
: Adjuvant chemoradiotherapy + adjuvant chemotherapy Pancreatic cancer patients who received surgery and both adjuvant chemoradiotherapy and chemotherapy.	RADIATION: Adjuvant chemoradiotherapy + Adjuvant chemotherapy See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival	Overall survival (OS) was defined as the time interval from the date of surgery to the date of death due to any cause or the date a patient was last known to be alive. Estimated by using the Kaplan-Meier method.	Up to 60 months

Secondary Outcome Measures	Measure Description	Time Frame
Disease Free Survival	Disease free survival (DFS) was defined as the time interval from the date of surgery to the date of disease recurrence or death or the date of a participant was last known to be alive without disease recurrence. Response was evaluated according to revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to 48 months

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: Yaolin Xu, M.D.

Phone Number: +86-18817583729

Email: xu.yaolin@zs-hospital.sh.cn

Study Contact Backup

Name: Wenhui Lou, M.D., Ph.D

Phone Number: +86-18817583729

Email: lou.wenhui@zs-hospital.sh.cn

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:

Collaborators and Investigators

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

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

Uesaka K, Boku N, Fukutomi A, Okamura Y, Konishi M, Matsumoto I, Kaneoka Y, Shimizu Y, Nakamori S, Sakamoto H, Morinaga S, Kainuma O, Imai K, Sata N, Hishinuma S, Ojima H, Yamaguchi R, Hirano S, Sudo T, Ohashi Y; JASPAC 01 Study Group. Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer: a phase 3, open-label, randomised, non-inferiority trial (JASPAC 01). Lancet. 2016 Jul 16;388(10041):248-57. doi: 10.1016/S0140-6736(16)30583-9. Epub 2016 Jun 2.
Goodman KA, Regine WF, Dawson LA, Ben-Josef E, Haustermans K, Bosch WR, Turian J, Abrams RA. Radiation Therapy Oncology Group consensus panel guidelines for the delineation of the clinical target volume in the postoperative treatment of pancreatic head cancer. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):901-8. doi: 10.1016/j.ijrobp.2012.01.022. Epub 2012 Apr 5.
Palta M, Godfrey D, Goodman KA, Hoffe S, Dawson LA, Dessert D, Hall WA, Herman JM, Khorana AA, Merchant N, Parekh A, Patton C, Pepek JM, Salama JK, Tuli R, Koong AC. Radiation Therapy for Pancreatic Cancer: Executive Summary of an ASTRO Clinical Practice Guideline. Pract Radiat Oncol. 2019 Sep-Oct;9(5):322-332. doi: 10.1016/j.prro.2019.06.016.
Ma SJ, Hermann GM, Prezzano KM, Serra LM, Iovoli AJ, Singh AK. Adjuvant chemotherapy followed by concurrent chemoradiation is associated with improved survival for resected stage I-II pancreatic cancer. Cancer Med. 2019 Mar;8(3):939-952. doi: 10.1002/cam4.1967. Epub 2019 Jan 16.
Abrams MJ, Huber KE, Knisely JP, Chang BW, Russo SM, Saif MW. Capecitabine as a Radiosensitizer in Adjuvant Chemoradiotherapy for Pancreatic Cancer: A Retrospective Study. Anticancer Res. 2015 Dec;35(12):6901-7.

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