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

Phase 3

• Conditions: Gastric Cancer
• Interventions: Drug: Adjuvant chemotherapy for active comparator group; Radiation: Adjuvant Concurrent Chemo-radiotherapy; Drug: Adjuvant chemotherapy for experimental group

• Registration Number: NCT02648841
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Status Verified: 2016-01
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-05
• Last Update Submitted: 2016-01-05
• Study First Posted: 2016-01-07
• Last Update Posted: 2016-01-07
• Primary Completion: 2020-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 588

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant Chemotherapy	Adjuvant chemotherapy for active comparator group	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.
Adjuvant Chemo-radiotherapy	Adjuvant Concurrent Chemo-radiotherapy	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.
Adjuvant Chemo-radiotherapy	Adjuvant chemotherapy for experimental group	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Over all survival	3 years
Local recurrence free survival	3 years
Distant metastasis free survival	3 years
Adverse Event	3 years

Trial Locations

Locations (1)

Cancer Hospital, Chinese academy of medical sciences; 🇨🇳 Bejing, Beijing, China