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

September 19, 2018 updated by: Xuefei.Wang, Shanghai Zhongshan Hospital

Phase III Multicenter Randomized Controlled Trial of Adjuvant Chemoradiotherapy vs Chemotherapy for Radical Resected Advanced Gastric Carcinoma Concurrent With Lymph Node Metastasis and Lymphovascular Invasion

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is an important health problem, being the fourth most common cancer and the third leading cause of cancer-related death worldwide. Age standardized mortality rates for gastric cancer are 14.3 per 100 000 in men and 6.9 per 100 000 in women. More than 679 000 new cases and 498,000 deaths occur every year in China.

Local recurrence is considered as the most common way of recurrence for advanced gastric cancer, as well as an important factor for poor prognosis. Radiotherapy is a widely used technique in Western countries, and has been identified to have a significant role in decreasing local recurrence rate in breast cancer, and colon rectal cancer. At this moment, several randomized controlled trials have been conducted to identify the role of radiotherapy in advanced gastric cancer. Although the results from Europe (INT-0116), Dutch (CRITICS), and Korea (ARTIST) did not find that radiotherapy could improve the overall survival of enrolled patients, the sub-group analyses demonstrated that radiotherapy could improve the disease-free survival in patients with lymph node metastasis. We also found that adjuvant chemoradiotherapy could improve the survival of patients with lymph node metastasis or lymphovascular Invasion based on a large cohort study from National Cancer Database.

Therefore, our hypothesis is that advanced gastric cancer patients with lymph node metastasis or lymphovascular invasion are the group entity that could benefit from radiotherapy. At present, a new clinical trial (ARTIST II), aiming at advanced gastric cancer with positive lymph node metastasis, has been launched. China is one of the countries with the highest incidence of gastric cancer, sand nearly 80% of patients are diagnosed with advanced stage. So it's necessary to conduct the clinical research on this issue.

This Enriched-CRT 2017 trial is a prospective, multicenter trial for adjuvant chemoradiotherapy (CRT) and chemotherapy (CT) in radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion. The primary purpose of this study is to evaluate the 3-year overall survival (OS), and 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.

Study Type

Interventional

Enrollment (Anticipated)

556

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Aged 18-75 years；
  • 2. 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;
  • 3. Received radical resection: R0 gastrectomy with D1/D2 lymphadenectomy (at least 15 lymph nodes were examined);
  • 4. 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+);
  • 5. No evidence of distant metastases was observed by perioperative imaging;
  • 6. Postoperative performance status (ECOG, Eastern Cooperative Oncology Group) of 0-2;
  • 7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
  • 8. Adequate hematological function: Hemoglobin (Hb) ≥100g/L, Neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLC) ≥100×109/L;
  • 9. 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;
  • 10. Adequate renal function: Serum creatinine ≤1.5mg/dl;
  • 11. Be able of oral feeding;
  • 12. Written informed consent.

Exclusion Criteria:

  • 1. Synchronous or metachronous (within 5 years) malignancies;
  • 2. Body temperature ≥ 38℃ or infectious disease with a systemic therapy indicated;
  • 3. Severe neurological or mental disease, including seizures or dementia, which may interfere compliance and sign of consent inform.
  • 4. 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;
  • 5. Severe respiratory disease;
  • 6. Moderate or severe renal dysfunction: Creatinine clearance rate (CCR) ≤50 ml/min, or Serum creatinine >ULN ;
  • 7. Upper gastrointestinal tract obstruction, physiological dysfunction, or malabsorption syndrome, which affect the absorption of oral drugs;
  • 8. Peripheral nervous disease (NCI CTC version> 1.0 grade), except for patients with ony disappeared deep tendinous reflect (DTR);
  • 9. Women during pregnancy or breast-feeding;
  • 10. Fertile women with a positive pregnancy test, or no pregnancy test; postmenopausal within 12 months;
  • 11. Fertile men or women who refuse to use contraception during the study period;
  • 12. Patients are participating or have participated in another clinical trial (within 6 months);
  • 13. Continuous systemic steroid therapy within 1 month (except for topical use), or received organ transplantation that needs immunosuppressive agent;
  • 14. Dihydropyrimidine dehydrogenase (DPD) deficiency;
  • 15. Allergy to platinum compound, or any component of drugs used in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant chemoradiotherapy group
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
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.
Other Names:
  • Study group (CRT)
Active Comparator: Adjuvant chemotherapy group
Adjuvant chemotherapy (6 cycles CT: Xelox or SOX, Q21d×3) for patients enrolled in this group.
Drug: chemotherapy
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.
Other Names:
  • Control group (CT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year Overall Survival
Time Frame: 3-year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year Disease Free Survival
Time Frame: 3-year
3-year Disease Free Survival (DFS) was defined as time from the date of enrollment to the date of recurrence or last visit.
3-year
Adverse effect (Safety and Tolerability)
Time Frame: 30 days
The evaluation of adverse effect is based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Xuefei Wang, MD, PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSGC-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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