Clinical trial · Interventional
Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer
Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer
NCT03601156CI-TRIAL-00034272PCARunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraarterial chemoembolization | Device | — | UNRESOLVED |
| intravenous chemotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NATACE-RT
- 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)
- interventionNames
- Device: intraarterial chemoembolization
- type
- ACTIVE_COMPARATOR
- label
- NACT-RT
- 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)
- interventionNames
- Device: intravenous chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDQian C, Yang W, Li M, Feng Y, Dai N, Luo H, Jian D, Li X, Yang Y, He Y, Wang D, Li C, Xiao H. Negative prognostic impact of Co-mutations in TGFbeta and TP53 pathways in surgically resected rectal tumors following neoadjuvant chemoradiotherapy. Eur J Surg Oncol. 2024 Apr;50(4):108242. doi: 10.1016/j.ejso.2024.108242. Epub 2024 Mar 6. PMID 38460248
- DERIVEDYang 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