Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
NCT ID: NCT03399253
Last Updated: 2018-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2017-12-10
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Surgery+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
surgery
D2 gastrectomy + metastasectomy
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
Interventions
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surgery
D2 gastrectomy + metastasectomy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Dazhi Xu
professor
Principal Investigators
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Dazhi Xu, PHD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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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
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, China
Yuebei People's Hospital
Guangzhou, Guangdong, China
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Yaming Zhang
Role: primary
Daibin Tang
Role: backup
Xuhui Zhao
Role: primary
Yifu He
Role: backup
Aman Xu
Role: primary
Fei Zhong
Role: backup
Lianghui Shi
Role: primary
Tao Tao Zhang
Role: primary
Huamin Rao
Role: primary
Li Chen
Role: primary
Rupeng Zhang
Role: primary
Other Identifiers
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GCGC004
Identifier Type: -
Identifier Source: org_study_id
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