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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03601988

Enrollment

408

Registered

2018-07-26

Start date

2018-07-28

Completion date

2022-07-28

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

gastric cancer, radiotherapy, postoperative

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

Interventions

RADIATIONConcurrent chemo-radiotherapy

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

DRUGChemotherapy

Chemotherapy group receive 8 cycles of XELOX.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Aged 18-75； 2. Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction； 3. ECOG 0-1； 4. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study; 5. D2 and R0 resection; 6. Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery; 7. More than 15 lymph nodes; 8. 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

1. Previous radiotherapy or chemotherapy； 2. Inadequate organ function; 3. Pregnant or lactating women or women of childbearing potential.

Design outcomes

Primary

Measure	Time frame	Description
DFS	36 months	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

Measure	Time frame	Description
OS	36 months	From date of randomization until the date of first documented death from any cause, assessed up to 36 months

Countries

China

Contacts

Primary ContactXianglin Yuan, MD,PhD

xlyuan1020@163.com8627-83663406

Backup ContactPing Peng, PhD,MD

pengpingtj@163.com8627-83663407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026