Clinical trial · Interventional
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
NCT01129700CI-TRIAL-00006805completedPhase 2ClinicalTrials.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)
Concurrent chemoradiotherapy (CRT) * Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1) * ↓ ↓ ↓ ↓ ↓ * Radical surgery 6 weeks after completion of chemoradiotherapy * ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5 * 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: short-course preoperative chemoradiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- short-course CRT-5FU
- interventionNames
- Radiation: Radiation: short-course preoperative chemoradiotherapy
Primary outcomes (1)
- measure
- To evaluate the pathologic response
- timeFrame
- After surgery with pathology data
- description
- downstaging(ypT0-2N0M0)rate
Secondary outcomes (2)
- measure
- Tumor regression grade & MR volumetry
- timeFrame
- After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery
- description
- To evaluate the tumor regression grade \& MR volumetry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria : * Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge) * Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS) * Age ≥18 * Performance Status(ECOG) 0-2 * CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Hemoglobin ≥ 10 g/dl, Absolute neutrophil count(ANC) ≥ 1,500 cells/㎣, Platelets ≥ 100,000cells/㎣ * Metabolic panel within 14 days prior to registration on study, with adequate liver and renal function defined as follows: AST and ALT ≤ 60 IU/L, bilirubin ≤ 1.5 mg/dl, serum creatinine ≤ 1.5 mg/dl * Patient must provide study-specific informed consent prior to study entry Exclusion Criteria : * Any evidence of distant metastases(M1) * Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years * Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc. * Impending obstruction (except the case with colostomy) * Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia * Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception * Unresected synchronous colon carcinoma * Clinically unresectable rectal cancer
References
Publications (0)
Data not yet available
No reference posted for this study.