Rectal Cancer
Conditions
Keywords
rectal cancer, intraarterial chemoembolization, radiotherpy, Oxaliplatin, Tegafur Gimeracil and Oteracil Porassium Capsule
Brief summary
Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. The purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal T3-T4 and/or N+ rectal cancer before operation.
Interventions
DEVICEintraarterial chemoembolization
DEVICEintravenous chemotherapy
Sponsors
Third Military Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic diagnosis of rectal cancer, Stage IV. * Males or females between 18 Years to 75 Years. * No prior cisplatin-based chemotherapy or radiotherapy. * Performance status of 0～2 on the ECOG criteria. * Adequate hematologic (Leukocyte count \>= 4,000/uL, neutrophil count \>= 1,500/uL, hemoglobin \>= 10 g/dL, platelets \>= 100,000/uL), hepatic (AST & ALT =\< upper normal limit(UNL)x1.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL x1.5 or creatinine clearance rate ≥60 ml/min) function. * Patient can take oral medicine * Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
Exclusion criteria
* Patient with allergic to S-1 or ingredient of Oxaliplatin * Patient with Peripheral neuropathy * Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days. * Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes. * Enrollment in other study. * Pregnant or breast-feeding. * Seriously psyche or intelligence problem. * Inability to comply with protocol or study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy | Pathological complete response (pCR) was determined on tumor resection specimens after completion of neoadjuvant therapy, and was defined as no evidence of residual invasive and ductal disease in the rectum and lymph nodes |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival | Following surgery, 5 years |
| Overall Survival | the first day of treatment to death or last survival confirm date; assesed up to 5 years |
| the Sphincter Preservation Rate | 3 month |
| Number of Participants with Adverse Events | Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks) |
| Number of Postoperative Complication | Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks) |
| Down Staging Rate | Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks) |
Countries
China
Contacts
Primary ContactDong Wang, PH.D.
Outcome results
None listed