Clinical trial · Interventional
CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
- 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)
Primary objective: * Pathological complete response (ypT0N0) rate Secondary objectives: * Histopathological R0 resection rate * Pathological downstaging (ypT0-T2N0) rate * One month surgical complication rate * Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes * Safety * Local and distant recurrence rates * Progression-free survival * Overall survival
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 Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, capecitabine, radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- interventionNames
- Drug: Oxaliplatin, capecitabine, radiotherapy
Primary outcomes (1)
- measure
- MRI staging and TME surgery
- timeFrame
- within 4 - 6 weeks after completion XELOX-RT
Secondary outcomes (1)
- measure
- Measure safety - NCI-CTC version 2
- timeFrame
- from baseline to end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge) * No evidence of distant spread * No prior therapy for chemotherapy or radiation therapy for rectal cancer * Patient considered locally advanced by MRI: * Tumour beyond mesorectal fascia, or * Tumour ≤ 2mm from mesorectal fascia, or * T3 tumour \< 5cm from anal verge * For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception * No peripheral neuropathy \> grade1 * ECOG PS ≤ 2 * ANC \> 1,500 x 10\^9/L * Platelets \> 100,000 x 10\^9/L * Creatinine \< 1.5 x IULN * Bilirubin \< 1.5 IULN * SGPT (ALT) \< 2.5 IULN * No pre-existing condition which would deter chemoradiotherapy * No uncontrolled diarrhoea or fecal incontinence * No significant small bowel (\> 200cc or 6X6X6cm) delineated within the radiation fields * No other serious uncontrolled concomitant illness * Informed consent signed The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available