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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Resectable Pancreatic Cancer; Adjuvant Chemoradiotherapy
• Intervention / Treatment: Other: Follow-up only; Drug: Adjuvant chemotherapy; Radiation: Adjuvant chemoradiotherapy; Radiation: Adjuvant chemoradiotherapy + Adjuvant chemotherapy

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• 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

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • ZhongShan Hospital FuDan University
      • Contact: Xiangyu Wang, M.D.; Phone Number: 86-021-31587871; Email: keyanke@zs-hospital.sh.cn
      • Principal Investigator: Wenhui Lou, M.D., Ph.D
      • Sub-Investigator: Lili Wu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elegible patients were those who received surgical resection of primary pancreatic tumor and were histologically diagonsed as pancreatic ductal adenocarcinoma.

Description

Inclusion Criteria:

1. Age between 18 to 90 years.
2. Received surgical resection of primary tumor.
3. Histological diagnosis of pancreatic ductal adenocarcinoma.
4. Signed informed consent.

Exclusion Criteria:

1.Active concomitant malignancy (Malignancy other than pancreatic cancer).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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 chemotherapy was followed the recommendation of NCCN guideline.
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 therapy (3DRT), intensity-modulated radiation therapy (IMRT) or tomotherapy (TOMO). S-1 was administered orally at a dose of 40mg twice a day during radiation day as radiosensitizer through radiotherapy. Antiemetic medications and proton pump inhibitor were prophylactic used to reduce the occurrence of nausea and inhibit gastric acid secretion.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events	Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, at any grade, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile.	Up to 60 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: A-RPC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No