Clinical trial · Interventional
Total Neoadjuvant Induction and Consolidation CapeOX Plus IMRT With Capecitabine for MRI Defined High-risk Rectal Cancer
Total Neoadjuvant Induction and Consolidation CapeOX Plus Neoadjuvant Intensity Modulated Radiotherapy With Concurrent Capecitabine for MRI Defined High-risk Rectal Cancer
NCT02864849CI-TRIAL-00052881completedPhase 2ClinicalTrials.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)
This study is designed to test the efficacy and safety of total neoadjuvant induction and consolidation CapeOX plus neoadjuvant intensity modulated radiotherapy with concurrent capecitabine for MRI defined high-risk 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Intensity modulated radiotherapy | Radiation | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TNT
- description
- Patients with MRI defined high-risk rectal cancer will receive chemotherapy before and after chemoradiation, and will not receive adjuvant treatment. This arm is called total neoadjuvant treatment (TNT). The neoadjuvant chemotherapy regimen is designed as 3 cycles of CapeOX (Capecitabine+Oxaliplatin) over a period of approximately 8 weeks. Tumor response will be evaluated after chemotherapy. Then patients will undergo 22f-IMRT (Intensity modulated radiotherapy) with capecitabine. Patients will receive two more cycles of consolidation CapeOX if tolerable when there was no progressed disease in induction CapeOX. Finally, patients will receive TME (Total mesorectal excision) following TNT if no metastasis occurs.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Radiation: Intensity modulated radiotherapy
- Procedure: Total mesorectal excision
Primary outcomes (1)
- measure
- Major adverse events
- timeFrame
- 3 years
- description
- Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years and ≤75 years. * ECOG Performance status 0-1. * Histologically confirmed diagnosis of adenocarcinoma of the rectum. * The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12 cm based on sigmoidoscopy. * Clinical Stage T3c, T3d, T4a or T4b, or EMVI (+) or mrN2 or CRM (+) based on MRI. * No evidence of distant metastases. * No prior pelvic radiation therapy. * No prior chemotherapy or surgery for rectal cancer. * No active infections requiring systemic antibiotic treatment. * ANC \> 1.5 cells/mm3, HGB \> 10.0 g/dL, PLT \> 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN. * Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Exclusion Criteria: * Recurrent rectal cancer. * Anticipated unresectable tumor after neoadjuvant treatment. * Creatinine level greater than 1.5 times the upper limit of normal. * Patients who have received prior pelvic radiotherapy. * Patients who are unable to undergo an MRI. * Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer. * Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA. * Other Anticancer or Experimental Therapy. * Women who are pregnant or breast-feeding. * Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
References
Publications (0)
Data not yet available
No reference posted for this study.