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

Launched by SUN YAT-SEN UNIVERSITY · Jan 8, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating two treatment options for patients with a specific type of gastric cancer (stomach cancer) that has one factor making it difficult to cure. The trial will compare chemotherapy alone to a combination of surgery to remove part of the stomach (called D2 distal gastrectomy) and chemotherapy. The goal is to see which treatment works better in terms of effectiveness and safety for patients with this condition.

To be eligible for the trial, participants should be between 18 and 75 years old and have a good performance status, meaning they are generally well enough to participate in the study. They should not have other types of cancer or serious health issues that could interfere with treatment. Participants can expect to receive either the chemotherapy treatment alone or the combination of surgery and chemotherapy, and they will be closely monitored throughout the study. It's important to note that this trial is currently recruiting participants, so those interested should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

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