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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Chemotherapy; Radiation: Concurrent chemo-radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03601988

TJCC007

Details and patient eligibility

About

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

Full description

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

Enrollment: 408 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

408 participants in 2 patient groups

Chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Chemotherapy

Chemo-radiotherapy

Experimental group

Description:

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)

Treatment:

Radiation: Concurrent chemo-radiotherapy