A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Adjuvant chemotherapy for active comparator group; Radiation: Adjuvant Concurrent Chemo-radiotherapy; Drug: Adjuvant chemotherapy for experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT02648841

NCC2015 YL-02

Details and patient eligibility

About

The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.

Enrollment: 588 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gastric cancer;
• D2 and R0 resection;
• Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging);
• Karnofsky performance score (KPS) >= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1;
• Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）
• No allergic history of 5-Fu or Platinum drugs;
• No history of chemotherapy or other anti-cancer therapy;
• Informed consent should be signed.

Exclusion criteria

• GEJ adenocarcinoma
• Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
• Allergic to Fluorouracil or Platinum drugs;
• Concurrent uncontrolled medical condition;
• Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
• Severe postoperative complications such as anastomotic leakage, etc.;
• Symptoms or history of peripheral neuropathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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588 participants in 2 patient groups

Adjuvant Chemotherapy

Active Comparator group

Description:

The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

Treatment:

Drug: Adjuvant chemotherapy for active comparator group

Adjuvant Chemo-radiotherapy

Experimental group

Description:

The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

Treatment:

Drug: Adjuvant chemotherapy for experimental group

Radiation: Adjuvant Concurrent Chemo-radiotherapy