Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NATACE-RT

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)

Group Type EXPERIMENTAL

intraarterial chemoembolization

Intervention Type DEVICE

NACT-RT

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)

Group Type ACTIVE_COMPARATOR

intravenous chemotherapy

Intervention Type DEVICE

Interventions

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intraarterial chemoembolization

Intervention Type DEVICE

intravenous chemotherapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No