Clinical trial · Interventional
Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer
NCT01186081CI-TRIAL-00003825completedPhase 3ClinicalTrials.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)
Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.
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 |
|---|---|---|---|
| Postoperative chemoradiotherapy | Radiation | — | UNRESOLVED |
| Preoperative chemoradiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative chemoradiotherapy
- description
- Preoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine)
- interventionNames
- Radiation: Preoperative chemoradiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Postoperative chemoradiotherapy
- description
- Postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine)
- interventionNames
- Radiation: Postoperative chemoradiotherapy
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed rectal adenocarcinoma * Tumor located below 10 cm from the anal verge * Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography (EUS) and computed tomography (CT) * Patients must be \> 18 years and \< 76 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate bone marrow reserve * Adequate renal function * Adequate liver function * Signed informed consent prior to randomization Exclusion Criteria: * Evidence of distant metastasis * Previous history of chemotherapy or radiotherapy * History of malignancy during recent 5 years other than skin cancer * Pregnant or lactating woman * Familial history of colorectal cancer
References
Publications (0)
Data not yet available
No reference posted for this study.