Clinical trial NCT03399253: Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Keywords: Distal Gastric Cancer, Gastrectomy, Metastasectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: 5-year
Secondary outcomes:
measure: progression free survival
timeFrame: 3-year
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing Municipal Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Sun Yat-sen University
name: Dazhi Xu, PHD
role: PRINCIPAL_INVESTIGATOR
References: