Clinical trial · Interventional
Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer
A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx Chemotherapy in Patients With Intermediate Risk Middle and Upper Rectal Cancer
NCT04103697CI-TRIAL-00049966RuCorT-01unknownPhase 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 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper 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
- 4xCapOx
- 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. 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. The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
- Radiation: Radiotherapy
- Procedure: Rectal cancer surgery
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Patients will receive standard surgery for rectal cancer with partial or total mesorectal excision (based on exact tumor location and surgeons discretion). The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Histologically verified colon rectal adenocarcinoma * cT3-4aN1-2M0 cancer of the upper rectum or сТ2-Т3bN1M0 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
References
Publications (0)
Data not yet available
No reference posted for this study.