Clinical trial NCT03601156: Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer
Official title: Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
intraarterial chemoembolization
radiotherpy
Oxaliplatin
Tegafur Gimeracil and Oteracil Porassium Capsule
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pathological Complete Response (pCR)
timeFrame: pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy
Secondary outcomes:
measure: the Sphincter Preservation Rate
timeFrame: 3 month
measure: Disease-free survival
timeFrame: Following surgery, 5 years
measure: Overall Survival
timeFrame: the first day of treatment to death or last survival confirm date; assesed up to 5 years
measure: Down Staging Rate
timeFrame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
measure: Number of Participants with Adverse Events
timeFrame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
measure: Number of Postoperative Complication
timeFrame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Zhongshan Hospital
state: Chongqing
city: Chongqing
country: China
facility: Jiangjin Central Hospital
state: Chongqing
Study officials:
References:
citation: Yang B, Shan J, Feng Y, Dai N, Li M, Chen C, He S, Wang G, Xiao H, Li C, Wang D. Transcatheter rectal arterial chemoembolization with oxaliplatin plus S-1 concurrent chemoradiotherapy can improve the pathological remission rate in locally advanced rectal cancer: a comparative study. Radiat Oncol. 2020 May 6;15(1):94. doi: 10.1186/s13014-020-01540-4.