Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer

NCT03601156 | Unknown DMC

• 1 other identifier: PCAR
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 3

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; intraarterial chemoembolization; radiotherpy; Oxaliplatin; Tegafur Gimeracil and Oteracil Porassium Capsule

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  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

  pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy

Secondary Outcomes (6)

• the Sphincter Preservation Rate

  3 month

• 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

• Down Staging Rate

  Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)

• Number of Participants with Adverse Events

  Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)

Study Arms (2)

NATACE-RT

EXPERIMENTAL

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)

Device: intraarterial chemoembolization

NACT-RT

ACTIVE COMPARATOR

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)

Device: intravenous chemotherapy

Interventions

intraarterial chemoembolization DEVICE

NATACE-RT

intravenous chemotherapy DEVICE

NACT-RT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (3)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Chongqing Zhongshan Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Jiangjin Central Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32375814 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Dong Wang, PH.D.

CONTACT

86-23-68757151; dongwang64@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: July 26, 2018
• Study Start: June 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: November 1, 2020
• Last Updated: August 10, 2018

Record last verified: 2018-07

Locations

CN (3)