Enriched-CRT 2017: Advanced Gastric Cancer With LN+ and LVI+, Chemotherapy vs. Chemoradiotherapy

NCT03680261 | Unknown Phase 3

• 1 other identifier: ZSGC-004
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

This Enriched-CRT 2017 trial is a prospective, multicenter trial for adjuvant chemoradiotherapy (CRT) and chemotherapy (CT) in radical resected advanced gastric cancer (GC) patients with lymph node metastasis (LN+) and lymphovascular Invasion (LVI+). The primary purpose of this study is to evaluate the 3-year overall survival (OS) of enrolled patients receiving adjuvant chemoradiotherapy compared with those receiving adjuvant chemotherapy. The second purpose is to evaluate 3-year disease free survival (DFS) and determine the safety of CRT compared with CT in the patients enrolled in this study.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Chemoradiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 3-year Overall Survival

  3-year Overall survival (OS) was defined as the time from the date of enrollment to the date of death or last visit.

  3-year

Secondary Outcomes (2)

• 3-year Disease Free Survival

  3-year

• Adverse effect (Safety and Tolerability)

  30 days

Study Arms (2)

Adjuvant chemoradiotherapy group

EXPERIMENTAL

Adjuvant chemoradiotherapy (1 cycle CT: Oxaliplatin plus capecitabine (Xelox) or S-1 plus oxaliplatin (SOX), Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine or S1, Followed by 3 cycles CT: Xelox or SOX, Q21d×3) for patients enrolled in this group.

Radiation: chemoradiotherapy

Adjuvant chemotherapy group

ACTIVE COMPARATOR

Adjuvant chemotherapy (6 cycles CT: Xelox or SOX, Q21d×3) for patients enrolled in this group.

Drug: chemotherapy

Interventions

chemoradiotherapy RADIATION

CRT (1 cycle CT: Xelox or SOX, Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine or S1, Followed by 3 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.

Also known as: Study group (CRT)

Adjuvant chemoradiotherapy group

chemotherapy DRUG

CT (6 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.

Also known as: Control group (CT)

Adjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18-75 years；
• \. Primary lesion is pathologically diagnosed as gastric adenocarcinoma (including Esophagogastric Junction adenocarcinoma), such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
• \. Received radical resection: R0 gastrectomy with D1/D2 lymphadenectomy (at least 15 lymph nodes were examined);
• \. Pathological stage pT2-4aN1-3M0 (According to American Joint Committee on Cancer (AJCC)-7th Tumor-Node-Metastasis (TNM) staging system), and with lymphovascular invasion, (LVI+);
• \. No evidence of distant metastases was observed by perioperative imaging;
• \. Postoperative performance status (ECOG, Eastern Cooperative Oncology Group) of 0-2;
• \. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
• \. Adequate hematological function: Hemoglobin (Hb) ≥100g/L, Neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLC) ≥100×109/L;
• \. Adequate liver function: ALT、AST ≤2.5x upper limit of normal (ULN), Alkaline phosphatase (ALP) ≤2.5x ULN, Serum total bilirubin (TBIL) \<1.5x ULN, Serum albumin(Alb) ≥30g/L;
• \. Adequate renal function: Serum creatinine ≤1.5mg/dl;
• \. Be able of oral feeding;
• \. Written informed consent.

You may not qualify if:

• \. Synchronous or metachronous (within 5 years) malignancies;
• \. Body temperature ≥ 38℃ or infectious disease with a systemic therapy indicated;
• \. Severe neurological or mental disease, including seizures or dementia, which may interfere compliance and sign of consent inform.
• \. Severe heart disease, including unstable angina pectoris, New York Heart Association (NYHA) class II or more advanced heart failure, severe arrhythmia despite medicinal treatment, or history of myocardial infarction within 12 months;
• \. Severe respiratory disease;
• \. Moderate or severe renal dysfunction: Creatinine clearance rate (CCR) ≤50 ml/min, or Serum creatinine \>ULN ;
• \. Upper gastrointestinal tract obstruction, physiological dysfunction, or malabsorption syndrome, which affect the absorption of oral drugs;
• \. Peripheral nervous disease (NCI CTC version\> 1.0 grade), except for patients with ony disappeared deep tendinous reflect (DTR);
• \. Women during pregnancy or breast-feeding;
• \. Fertile women with a positive pregnancy test, or no pregnancy test; postmenopausal within 12 months;
• \. Fertile men or women who refuse to use contraception during the study period;
• \. Patients are participating or have participated in another clinical trial (within 6 months);
• \. Continuous systemic steroid therapy within 1 month (except for topical use), or received organ transplantation that needs immunosuppressive agent;
• \. Dihydropyrimidine dehydrogenase (DPD) deficiency;
• \. Allergy to platinum compound, or any component of drugs used in the study.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (18)

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Chemoradiotherapy; Drug Therapy; Control Groups

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xuefei Wang, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefei Wang, MD, PhD

CONTACT

86-13917270428; wang.xuefei@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor,Department of General Surgery, Zhongshan Hospital

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)