NCT04737551

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

January 25, 2021

Last Update Submit

February 1, 2021

Conditions

Resectable Pancreatic CancerAdjuvant ChemoradiotherapySurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Disease Free Survival

    Up to 48 months

Other Outcomes (1)

  • Number of Participants Experiencing Adverse Events

    Up to 60 months

Study Arms (4)

No adjuvant treatment

Pancreatic cancer patients who received surgery without subsequent adjuvant treatment.

Other: Follow-up only

Adjuvant chemotherapy

Pancreatic cancer patients who received surgery and only adjuvant chemotherapy.

Drug: Adjuvant chemotherapy

Adjuvant chemoradiotherapy

Pancreatic cancer patients who received surgery and only adjuvant chemoradiotherapy.

Radiation: Adjuvant chemoradiotherapy

Adjuvant chemoradiotherapy + adjuvant chemotherapy

Pancreatic cancer patients who received surgery and both adjuvant chemoradiotherapy and chemotherapy.

Radiation: Adjuvant chemoradiotherapy + Adjuvant chemotherapy

Interventions

Follow-up onlyOTHER

Only routine follow-up but no treatment

No adjuvant treatment
Adjuvant chemotherapyDRUG

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 chemotherapy
Adjuvant chemoradiotherapyRADIATION

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 chemoradiotherapy + Adjuvant chemotherapyRADIATION

See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).

Adjuvant chemoradiotherapy + adjuvant chemotherapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27265347BACKGROUND

  • 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.

    PMID: 22483737BACKGROUND

  • 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.

    PMID: 31474330BACKGROUND

  • 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.

    PMID: 30652417BACKGROUND

  • 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.

    PMID: 26637914BACKGROUND

MeSH Terms

Interventions

Chemotherapy, AdjuvantChemoradiotherapy, Adjuvant

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyChemoradiotherapyRadiotherapy

Central Study Contacts

Yaolin Xu, M.D.

CONTACT

+86-18817583729xu.yaolin@zs-hospital.sh.cn

Wenhui Lou, M.D., Ph.D

CONTACT

+86-18817583729lou.wenhui@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 4, 2021

Study Start

January 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

CN(1)