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Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Concurrent chemo-radiotherapy

Chemotherapy

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, radiotherapy, postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy

Chemo-radiotherapy

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03601988

First Posted

July 15, 2018

Last Updated

July 25, 2018

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT03601988

Brief Title

Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer

Official Title

A Randomized Phase III Trial of Postoperative Chemotherapy or Chemo-radiotherapy for Locally Advanced Gastric Cancer After D2 Resection

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 28, 2018 (Anticipated)

Primary Completion Date

July 28, 2020 (Anticipated)

Study Completion Date

July 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

The radiotherapy dose of 45Gy in 25 fractions as adjuvant treatment after D2 surgery for gastric cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

gastric cancer, radiotherapy, postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

All patients randomized to receive chemotherapy or chemo-radiotherapy after D2 surgery

Masking

None (Open Label)

Allocation

Randomized

Enrollment

408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Chemo-radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Concurrent chemo-radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Chemotherapy group receive 8 cycles of XELOX.

Primary Outcome Measure Information:

Title

DFS

Description

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

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Description

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

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Previous radiotherapy or chemotherapy； Inadequate organ function; Pregnant or lactating women or women of childbearing potential.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xianglin Yuan, MD,PhD

Phone

8627-83663406

xlyuan1020@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ping Peng, PhD,MD

Phone

8627-83663407

pengpingtj@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xianglin Yuan, MD,PhD

Organizational Affiliation

Tongji Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianglin Yuan, MD,PHD

Phone

8627-83663406

Ext

xlyuan1020@163.com

First Name & Middle Initial & Last Name & Degree

Ping Peng, MD,PHD

Phone

8627-83663407

Ext

pengpingtj@163.com

First Name & Middle Initial & Last Name & Degree

Xianglin Yuan, MD,PHD

First Name & Middle Initial & Last Name & Degree

Ping Peng, MD,PHD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25559811

Citation

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.

Results Reference

background

PubMed Identifier

17978289

Citation

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. Erratum In: N Engl J Med. 2008 May 1;358(18):1977.

Results Reference

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PubMed Identifier

25439693

Citation

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.

Results Reference

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PubMed Identifier

11547741

Citation

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.

Results Reference

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PubMed Identifier

27433396

Citation

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.

Results Reference

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PubMed Identifier

22184384

Citation

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.

Results Reference

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Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer

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