Clinical trial · Interventional
Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer
Induction and Consolidation Chemotherapy in Locally Advanced Rectal Cancer Patients With Circumferential Resection Margin Involvement: a Multicenter Prospective Randomized Phase III Clinical Trial
NCT04135313CI-TRIAL-00049952RuCorT-03unknownPhase 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 the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low 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 receive 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
- Radiation: Radiotherapy
- Procedure: Rectal cancer surgery
- type
- ACTIVE_COMPARATOR
- label
- Chemoradiotherpy
- description
- Patients receive 54 Gy pelvic chemoradiotherapy in 2 Gy fractions with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 10-12 weeks. After surgery patients receive 6 cycles of adjuvant CapOx chemotherapy.
- interventionNames
- Drug: Capecitabine
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 0-10 cm above the anal verge * No distant metastases * Circumferential resection margin (CRM) involvement (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 * cT2N0M0 rectal cancer * 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.