Clinical trial · Interventional
Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer
A Randomized Phase II Trial of Preoperative Chemoradiation (Preop CRT) Followed by CapOx (Capecitabine Plus Oxaliplatin) Versus Preop CRT Alone for Locally Advanced Rectal Cancer (LARC)
NCT01952951CI-TRIAL-00029508PREPAREunknownPhase 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)
The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine Oxaliplatin | Drug | CAPOX Regimen | ALIAS |
| pelvic radiation capecitabine 5-fluorouracil | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- chemoradiation followed by CapOx
- description
- preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision)
- interventionNames
- Drug: Capecitabine Oxaliplatin
- Radiation: pelvic radiation capecitabine 5-fluorouracil
- type
- ACTIVE_COMPARATOR
- label
- chemoradiation
- description
- preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision)
- interventionNames
- Radiation: pelvic radiation capecitabine 5-fluorouracil
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed adenocarcinoma of the rectum * distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination * high risk clinical stage II or III in MRI (satisfying at least one of the followings) * circumferential resection margin \< 1 mm involved * low-lying tumor below anal verge 3 cm * T3 \> 5 mm extramural spread * T4 (involving surrounding structures or peritoneum) * cN2 (4 or more mixed signal intensity or irregularly bordered node or tumor deposit) * age 20 years or more * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * No prior chemotherapy, radiotherapy to pelvis * Adequate bone marrow function * Adequate renal function * Adequate hepatic function * patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: * malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease * any unresected synchronous colon cancer * any distant metastases * intestinal obstruction or impending obstruction, but decompressing colostomy is permitted * any previous or concurrent malignancy withih 5 years other than non-melanoma skin cancer / in situ cancer of uterine cervix / early gastric cancer / thyroid cancer of low risk * any other morbidity or situation with relative contraindication for chemoradiotherapy * patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine * pregnant or lactating women or patients of childbearing potential not predicting adequate contraception
References
Publications (1)
- DERIVEDKim SY, Joo J, Kim TW, Hong YS, Kim JE, Hwang IG, Kim BG, Lee KW, Kim JW, Oh HS, Ahn JB, Zang DY, Kim DY, Oh JH, Baek JY. A Randomized Phase 2 Trial of Consolidation Chemotherapy After Preoperative Chemoradiation Therapy Versus Chemoradiation Therapy Alone for Locally Advanced Rectal Cancer: KCSG CO 14-03. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):889-899. doi: 10.1016/j.ijrobp.2018.04.013. Epub 2018 Apr 12. PMID 29976501