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

Gastric Cancer Clinical Trial

Official title:

A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial of Chemotherapy Alone Versus D2 Gastrectomy and Metastasectomy Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399253
• Other study ID #: GCGC004
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 8, 2018
• Last updated: January 8, 2018
• Start date: December 10, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2018
• Source: Sun Yat-sen University
• Contact: Dazhi Xu, PHD
• Phone: (+86) 020-87343737
• Email: xudzh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• surgery
D2 gastrectomy + metastasectomy

Drug:
• chemotherapy
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

Locations

Country	Name	City	State
China	Anqing Municipal Hospital	Anqing	Anhui
China	Cancer Center of Sun Yat-sen University	Guangzhou	Guangdong
China	Yuebei People's Hospital	Guangzhou	Guangdong
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	OS	5-year
Secondary	progression free survival	PFS	3-year