Clinical trial · Interventional
Brazilian Total Neoadjuvant Therapy Trial
A Prospective Randomized Controlled Trial of Total Neo-adjuvant Therapy vs Conventional Chemo-radiation Aiming at Increasing Rates of Clinical Complete Response in Locally Advanced Rectal Cancer
- 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)
Standard therapy for localized rectal cancer includes chemotherapy and radiation therapy, followed by a "recovery" period of 7-12 weeks, surgery and adjuvant chemotherapy for 3-6 months. Even though this protocol achieves high cure rates, many patients need a rectal amputation with placement of definitive colostomies. About 10-20% of patients have a complete clinical response to chemo-radiation and no tumor can be found in the surgical specimen. These patients can be followed with close surveillance and avid surgery. The aim of this study is to evaluate if a strategy including the use of a highly active chemotherapy called "FOLFIRINOX" during the 12 weeks between the end of radiation therapy and evaluation for surgery increases the rates of complete response and, therefore, allows more patients to undergo non-surgical management.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folfirinox | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Total neoadjuvant therapy (TNT)
- description
- 4 cycles of mFOLFIRINOX every 14 days: * Oxaliplatin 85 mg/m2 * Irinotecan 150mg/m2 * 5-FU 2.400mg/m2 * Dexamethasone 12mg * Atropine 0.5mg * Netupitant/palonosetron
- interventionNames
- Drug: Folfirinox
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Standard post-radiation care
Primary outcomes (1)
- measure
- cCR + PathCR
- timeFrame
- 12 weeks after the end of chemoradiation
- description
- Complete clinical response or pathological response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 y/o * Biopsy-confirmed rectal adenocarcinoma * Tumor Stage T3+ or N+ M0 * Adequate liver function (total bilirubin \< = 4.0) * Adequate kidney function (calculate creatinine-clearance \>=30ml/m2/min) * Adequate bone marrow function (Platelet counts \>=90.000, hemoglobin \>=8mg/dl, neutrophile count \>= 1.500/cm3) * Completed chemo-radiation with at least 54Gy and capecitabine 1650mg/m2/d Exclusion Criteria: * Prior tumor resection * Prior radiation to the pelvis * Prior chemotherapy for rectal cancer * Life expectancy \< 6 months * Unfit for surgery * Need for urgent/ immediate surgery
References
Publications (0)
Data not yet available