Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor

Phase 2

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: chemotherapy; Procedure: surgery

• Registration Number: NCT03399253
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Our study aims to compare the efficacy and safety of Chemotherapy Alone Versus D2 distal gastrectomy and metastasectomy plus Chemotherapy for gastric cancer (GC) with one non-curable Factor

Detailed Description

Gastric cancer is the fourth most common malignancy worldwide and the second leading cause of cancer-related deaths, with the highest mortality rates reported in East Asia, including China. Many patients are diagnosed at an advanced stage of gastric cancer because of late onset and nonspecific symptoms. The prognosis of patients with advanced gastric cancer with non-curable factors, such as hepatic, peritoneal, or distant lymph node metastases, is poor. Chemotherapy is the standard of care for these patients. Palliative resection or bypass surgery is generally indicated in the presence of major symptoms such as bleeding or obstruction for incurable advanced gastric cancer. The usefulness of gastrectomy and metastasectomy is still unclear.

The REGATTA trial is the first clinical trial to explore the significance of surgery for incurable advanced gastric cancer. However, it concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, there was a significant interaction between treatment effect and tumor location in subgroup analyses of overall survival. Gastrectomy plus chemotherapy was associated with significantly worse overall survival in patients with upper-third tumors for less chemotherapy cycles. This finding raises the question whether inclusion criteria were restricted to the patients with lower-third tumor, findings of study might have been positive. So we raise this new trail to assess the significance of Gastrectomy and Metastasectomy for Distal Gastric Cancer With One Non-curable Factor.

Study Timeline

• Study Start: 2017-12-10
• Status Verified: 2018-01
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-08
• Last Update Submitted: 2018-01-08
• Study First Posted: 2018-01-16
• Last Update Posted: 2018-01-16
• Primary Completion: 2022-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Lower age limit of research subjects 18 years old and upper age limit of 75 years old.

2. PS (ECOG) of 0 or 1.

3. Without any other malignancies.

4. Written informed consent from the patient.

5. Standard gastrectomy with D2 lymphadenectomy for primary cancer

6. A single non-curable factor was defined by preoperative CT :

   hepatic metastasis (H1 or H2; maximum diameter ≤4 cm, number ≤4); peritoneal metastasis (R0 or R1 resection) para-aortic lymph node metastasis （number ≤4) ovarian metastasis adrenal metastasis renal metastasis

7. No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L)

Exclusion Criteria

1. Female in pregnancy or lactation.
2. Supraclavicular lymph nodes metastases，lung and bone metastases.
3. Massive ascites or cachexia.
4. Extensive cancer metastases of liver, peritoneal metastasis,para-aortic lymph node
5. Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
6. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
7. Poor treatment compliance of patients
8. The group of chemotherapy alone accepts gastrectomy for bleeding or obstruction
9. Failure of R0 or R1 metastasectomy and gastrectomy with D2 lymphadenectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	chemotherapy	chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
Surgery+Chemotherapy	surgery	D2 Gastrectomy and Metastasectomy + chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
Surgery+Chemotherapy	chemotherapy	D2 Gastrectomy and Metastasectomy + chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease

Primary Outcome Measures

Name	Time	Method
Overall survival	5-year	OS

Secondary Outcome Measures

Name	Time	Method
progression free survival	3-year	PFS

Trial Locations

Locations (9)

Anqing Municipal Hospital; 🇨🇳 Anqing, Anhui, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

First Affiliated Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

Yuebei People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Cancer Center of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Jiangxi Provincial Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China