Survival
Conditions
Keywords
Intraperitoneal chemotherapy, gastric cancer, Neo-adjuvant chemotherapy
Brief summary
The investigators intend to conduct a randomized controlled study to find if combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection could improve survival for patients with advanced gastric cancer, while comparing with the traditional approach of D2 resection after neoadjuvant chemotherapy.
Detailed description
Gastric cancer, as the second common malignant tumors in china, is marked by its poor prognosis and high recurrent rate. Although R0 resection could be achieved in most advanced gastric cancer(AGC) patients without metastasis, age-standardized 5-years survival rate was no more than 27.4%. Peritoneal metastasis accounts for 50% of the recurrent case and remain to be the most fatal recurrence pattern. Hyperthermic intraperitoneal perfusion chemotherapy ( HIPEC ), has been proved as one of the most efficient approach against peritoneal carcinomatosis from gastric cancer and recommended in the guideline for gastric cancer published by the health committee of china. However, its role as prophylactic treatment after curative has never been determined. HIPEC works by delivering heat and cytotoxic drug to the cancer cell and is more effective on the tumor with small size. As present study suggest that Peritoneal metastasis is related to lymph node dissection during surgery while opening lymphatic channels and spreading viable cancer cells into the peritoneal cavity, HIPEC might be a reasonable approach to destroy the remaining cancer cells after curative surgery. Thus this research aim to explore the efficacy and safety of combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection.
Interventions
DRUGNeoadjuvant chemotherapy
Eligible patients receive 4 cycles of mDOF(docetaxel 50 mg/ m2 day 1 + oxaliplatin 85 mg/ m2 day 2 + fluorouracil 400 mg/ m2 bolus iv followed by 600 mg/ m2 22 hours chronic infusion, day 2/3 + leucovorin 200 mg/ m2, day2/3; repeated every 14 days ).
PROCEDURED2 radical resection
Laparotomy or laparoscopic surgery are chosen according to the preference of the surgeon. Either cases, a throughout peritoneal cavity exploration is required to comfirmed the tumor resectability and peritoneal metastasis. A curative D2 resection is performed if achievable.
DRUGHyperthermic intraperitoneal perfusion chemotherapy
Two cycle of hyperthermic intraperitoneal perfusion chemotherapy is administered to patients who have received neoadjuvant chemotherapy and D2 resection, dosage and the relative parameter setting is described above.
DRUGAdjuvant chemotherapy
Adjuvant chemotherapy using SOX or XELOX regimen will be administered as routine within 4-6 weeks.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. First diagnosed as gastric cancer by pathological examination; 2. No previous chemotherapy or radiotherapy; 3. T stage:3-4, N stage: 1-3, M stage: 0, assessed by CT or ultrasound endoscope; 4. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1; 5. Informed consent signed;
Exclusion criteria
1. Other malignancy within 5 years. 2. Peritoneal metastasis detected during surgery. 3. Pregnant or lactating women; 4. Patients with conditions requiring emergency surgery; 5. Tumor progress during neo-adjuvant chemotherapy 6. Severe, uncontrolled physical or metal disease. 7. Poor compliance. 8. Uncontrolled infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of survival participants will be assessed according to the data collected by the followed up office. | 1-5 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 1-3 years |
Countries
China
Contacts
Primary ContactHua-She Wang, PhD
Backup ContactJun-Sheng Peng, PhD
Outcome results
None listed