Clinical trial · Interventional
Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer
Safety and Efficacy of Induction and Individualized Neoadjuvant Chemotherapy Based on Oxaliplatin Combined With Fluorouracil for MRF-negative, Moderate-risk and Initially Resectable Middle and Low Rectal Cancer
NCT04296240CI-TRIAL-00043811unknownPhase 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 Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin and capecitabine | Drug | — | UNRESOLVED |
| Total Mesorectal Excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy
- description
- Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles;
- interventionNames
- Drug: Oxaliplatin and capecitabine
- Procedure: Total Mesorectal Excision
Primary outcomes (1)
- measure
- pathologic complete response rate
- timeFrame
- 30 days
- description
- the number of patients with pCR divided by the total number of patients
Secondary outcomes (3)
- measure
- 3 year disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* • Age ≥18 years and ≤80 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 ≤12cm based on sigmoidoscopy;
* Clinical Stage based on MRI
1. mrMRF(-)
2. T3c/T3d/T4a, anyN, or T3bN+
* 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
* Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins.
* The pathological grade was Grade 4, i.e. mucus, signet ring or undifferentiated cancer.
* 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.