Comparing chemotherapy alone to surgery plus chemotherapy for advanced gastric cancer
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
This study is testing whether chemotherapy alone is as effective and safe as surgery followed by chemotherapy for people with advanced gastric cancer that has one non-curable factor.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Anqing, Anhui and 8 other locations) |
| Trial ID | NCT03399253 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of chemotherapy alone versus a combination of D2 distal gastrectomy and metastasectomy followed by chemotherapy in patients with distal gastric cancer that has one non-curable factor. Gastric cancer is a significant health concern, particularly in East Asia, where many patients present with advanced disease. The trial seeks to clarify the role of surgical intervention in this context, as previous studies have shown mixed results regarding its benefits. Participants will be closely monitored for outcomes related to survival and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a single non-curable factor related to their gastric cancer and an ECOG performance status of 0 or 1.
Not a fit: Patients with extensive metastases, such as lung or bone involvement, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into whether surgical intervention improves outcomes for patients with advanced gastric cancer.
How similar studies have performed: Previous studies have shown mixed results regarding the benefits of surgical intervention in similar patient populations, making this trial particularly relevant.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Anqing, Anhui and 8 other locations
- Anqing Municipal Hospital — Anqing, Anhui, China (Recruiting)
- Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
- First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Recruiting)
- Cancer Center of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- Yuebei People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Jiangxi Provincial Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Dazhi Xu, PHD — Sun Yat-sen University
- Study coordinator: Dazhi Xu, PHD
- Email: xudzh@sysucc.org.cn
- Phone: (+86) 020-87343737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.