Clinical trial · Interventional
Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer
A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx in Patients With Intermediate Risk CRM-negative Middle Rectal Cancer
NCT04134897CI-TRIAL-00049932RuCorT-02unknownPhase 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)
The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.
Conditions
Conditions (3)
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 |
| Rectal Neoplasms Malignant | — | UNRESOLVED | — |
| Rectum Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Rectal cancer surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy
- description
- Patients will receive 4 cycles of neoadjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks). In case of partial response or stable disease (based on pelvic MRI) patients proceed to surgery within 2 weeks. In case of disease progression patients receive 50 Gy pelvic chemoradiotherapy with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 8-10 weeks. After surgery patients receive 4 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
- Radiation: Radiotherapy
- Procedure: Rectal cancer surgery
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant radiotherapy
- description
- Patients will receive 5x5 Gy radiotherapy and then surgery following 6-8 weeks. After surgery patients receive 8 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Histologically verified colon rectal adenocarcinoma * сT3c-T3dN0-1M0, cT1-T3dN2M0. cancer of the middle rectum (based on pelvic MRI) * Tumor more than 2 mm from mesorectal fascia (based on pelvic MRI) * Eastern Cooperative Oncology Group (ECOG) status 0-2 * Haemoglobin (HGB) \> 90 g/L * Platelet Count (PLT) \> 120x10\*9/L * Serum creatinine \< 150 µmol/L * Total bilirubin \< 25 µmol/L Exclusion Criteria: * inability to obtain informed consent * distant metastases * synchronous or metachronous tumors * previous chemotherapy or radiotherapy * clinically significant cardiovascular disorders (myocardial infarction \< 6 months before visit, stroke \< \< 6 months before visit, instable angina \< 3 months before visit, arrhythmia, uncontrolled hypertension \> 160/100 mm hg * clinically significant neurological disorders * previous neuropathy 2 or higher * current infection or heavy systemic disease * pregnancy, breastfeeding * ulcerative colitis * individual intolerance to treatment components * proven dihydropyrimidine dehydrogenase (DPD) deficiency * participation in other clinical trials * psychiatric disorders, which render patient unable to follow instructions or understand his/her condition * technical inability to perform pelvic MRI * inability of long-term followup of the patient * HIV
References
Publications (0)
Data not yet available
No reference posted for this study.