Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer (PCAR)

Third Military Medical University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Device: intravenous chemotherapy; Device: intraarterial chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03601156

PCAR

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

NATACE-RT

Experimental group

Description:

Patients receive Oxaliplatin 130mg/m2 intraarterial chemoembolization on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA \< 1.25 mm2 receive 80 mg/day; 1.25 mm2 \< BSA \< 1.5mm2 recive 100 mg/day, BSA\>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks)

Treatment:

Device: intraarterial chemoembolization

NACT-RT

Active Comparator group

Description:

Patients receive Oxaliplatin 130mg/m2 intravenous chemotherapy on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA \< 1.25 mm2 receive 80 mg/day; 1.25 mm2 \< BSA \< 1.5mm2 recive 100 mg/day, BSA\>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks)

Treatment:

Device: intravenous chemotherapy