Brazilian Total Neoadjuvant Therapy Trial

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Israelita Albert Einstein
• Collaborator: Ministry of Health, Brazil
• Treatments: Folfirinox; Irinotecan; Oxaliplatin

Criteria

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