Pancreatic cancer
Conditions
Interventions
Research Group:S-1 combined with TOMO radiotherapy, sequential S-1 maintenance chemotherapy
Control Group:S-1 combined with IMRT radiotherapy, sequential S-1 maintenance chemotherapy
Sponsors
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntary participation and written informed consent form; 2) Age >18 years old, male and female; 3) PS 0-1 for ECOG class; 4) Life expectancy of at least 3 months; 5) Be able to comply with the test plan; 6) Histology or clinical manifestation, imaging, and serum CA199 parameters in the diagnosis of surgical resection of locally advanced pancreatic cancer; Imaging criteria for surgical resection: The head of the pancreas: (1) There's a distant metastasis; (2) Tumors around SMA greater than 180, or invasion of the celiac trunk (any degree); (3) SMV/ portal vein occlusion and cannot be reconstructed; (4) Tumor invasion or abdominal aorta; (5) Tumor invasion of the abdominal aorta; The body of pancreas: (1) There's a distant metastasis; (2) Tumors around SMA or celiac trunk greater than 180 degrees; (3) SMV/ portal vein occlusion and cannot be reconstructed; (4) Tumor invasion of the abdominal aorta; The tail of the pancreas: (1) There's a distant metastasis; (2) Tumors around SMA or celiac trunk greater than 180 degrees. Lymph node status: (1) The extent of lymph node metastasis is beyond the scope of operation; (2) Tumor invasion of the abdominal aorta; 7. With measurable lesions in accordance with the criteria for the evaluation of solid tumor remission (RECIST); 8. No severe blood system, heart, lung, liver, renal dysfunction and immune deficiency; 9. Hemoglobin (Hb) = 9 g/dL; white blood cell (WBC) = 3 * 109/L; neutrophil (ANC) = 1.5 * 109/L; platelet (Pt) = 100 * 10^9/L; 10. Bilirubin <1.5 times the upper limit of normal value; aspartate aminotransferase (ALT) and alanine aminotransferase (AST) less than 2.5 times the upper limit of normal value; 11. Serum creatinine is less than 1.5 times the upper limit of normal value; 12. Male or female reproductive capacity in the trial is willing to take contraceptive measures.
Exclusion criteria
Exclusion criteria: 1)Prior treatment of chemotherapy, radiotherapy, biological targeted therapy or local treatment for locally advanced pancreatic cancer; 2) Receive a major surgical treatment within 28 days before the start of the trial; 3) Patients with a history of malignant tumor (skin basal cell carcinoma and cervical carcinoma in situ after treatment except for 3 years or more); 4) Participate in other clinical trials in the first 4 days of treatment; 5) Drug addiction, long-term alcohol abuse and AIDS patients; 6) There are uncontrol seizures, or mental illness due to loss of insight; 7) Patients with active infections of the need for intravenous antibiotic therapy at the time of randomization; 8) Active gastrointestinal bleeding; 9) Pregnant or lactating women; 10) The researchers think it is not appropriate to participate in the test;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Countries
China
Contacts
Public ContactLeizhen Zheng
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed