NCT03601988

Brief Summary

The purpose of this study is to explore the efficacy of adjuvant radiotherapy for D2 resected gastric 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
408

participants targeted

Target at P50-P75 for phase_3 gastric-cancer

Timeline
Completed

Started Jul 2018

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

First Submitted

Initial submission to the registry

July 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 28, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

July 15, 2018

Last Update Submit

July 25, 2018

Conditions

Gastric Cancer

Keywords

gastric cancerradiotherapypostoperative

Outcome Measures

Primary Outcomes (1)

  • DFS

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

    36 months

Secondary Outcomes (1)

  • OS

    36 months

Study Arms (2)

Chemotherapy

ACTIVE COMPARATOR

Adjuvant chemotherapy group receive 8 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1,capecitabine 1000mg po, Bid, D1-14, Q21D)

Drug: Chemotherapy

Chemo-radiotherapy

EXPERIMENTAL

Adjuvant chemo-radiotherapy group receive 6 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1, capecitabine 1000mg po, Bid, D1-14, Q21D) and concurrent chemo-radiotherapy (capecitabine 825mg po, Bid, d1-5, QW)

Radiation: Concurrent chemo-radiotherapy

Interventions

Concurrent chemo-radiotherapyRADIATION

Experimental group receive 6 cycles of XELOX chemotherapy and concurrent chemo-radiotherapy. The radiotherapy dose of 45Gy in 25 fractions delivered by IMRT Radiotherapy

Chemo-radiotherapy
ChemotherapyDRUG

Chemotherapy group receive 8 cycles of XELOX.

Chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75；
  • Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction；
  • ECOG 0-1；
  • Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
  • D2 and R0 resection;
  • Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery;
  • More than 15 lymph nodes;
  • Adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

You may not qualify if:

  • Previous radiotherapy or chemotherapy；
  • Inadequate organ function;
  • Pregnant or lactating women or women of childbearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (6)

  • Park SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. doi: 10.1200/JCO.2014.58.3930. Epub 2015 Jan 5.

    PMID: 25559811BACKGROUND

  • Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.

    PMID: 17978289BACKGROUND

  • Noh SH, Park SR, Yang HK, Chung HC, Chung IJ, Kim SW, Kim HH, Choi JH, Kim HK, Yu W, Lee JI, Shin DB, Ji J, Chen JS, Lim Y, Ha S, Bang YJ; CLASSIC trial investigators. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1389-96. doi: 10.1016/S1470-2045(14)70473-5. Epub 2014 Oct 15.

    PMID: 25439693BACKGROUND

  • Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.

    PMID: 11547741BACKGROUND

  • Kim Y, Park SH, Kim KM, Choi MG, Lee JH, Sohn TS, Bae JM, Kim S, Lee SJ, Kim ST, Lee J, Park JO, Park YS, Lim HY, Kang WK. The Influence of Metastatic Lymph Node Ratio on the Treatment Outcomes in the Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) Trial: A Phase III Trial. J Gastric Cancer. 2016 Jun;16(2):105-10. doi: 10.5230/jgc.2016.16.2.105. Epub 2016 Jun 24.

    PMID: 27433396BACKGROUND

  • Lee J, Lim DH, Kim S, Park SH, Park JO, Park YS, Lim HY, Choi MG, Sohn TS, Noh JH, Bae JM, Ahn YC, Sohn I, Jung SH, Park CK, Kim KM, Kang WK. Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with D2 lymph node dissection: the ARTIST trial. J Clin Oncol. 2012 Jan 20;30(3):268-73. doi: 10.1200/JCO.2011.39.1953. Epub 2011 Dec 19.

    PMID: 22184384BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Xianglin Yuan, MD,PhD

    Tongji Hospital

    STUDY CHAIR

Central Study Contacts

Xianglin Yuan, MD,PhD

CONTACT

8627-83663406xlyuan1020@163.com

Ping Peng, PhD,MD

CONTACT

8627-83663407pengpingtj@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All patients randomized to receive chemotherapy or chemo-radiotherapy after D2 surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of the cancer center

Study Record Dates

First Submitted

July 15, 2018

First Posted

July 26, 2018

Study Start

July 28, 2018

Primary Completion

July 28, 2020

Study Completion

July 28, 2022

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

CN(1)