A Phase 3 interventional study of Folfirinox in Colorectal Neoplasms, sponsored by Hospital Israelita Albert Einstein. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Hospital Israelita Albert Einstein · Phase 3, Interventional, and Treatment
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.
Adult patients with locally advanced rectal cancer who have completed conventional long-course chemo-radiation of 54Gy with capecitabine will be randomized 1:1 to a total neo-adjuvant therapy (TNT) protocol or to a control group. Patients in the TNT arm will receive 4 cycles of interval chemotherapy with FOLFIRINOX (5-FU, irinotecan, oxaliplatin) between the end of chemo-radiation and re-staging and those in the control group will undergo standard post-radiation care during this period. All patients will be re-staged with colonoscopy and pelvic MRI 12 weeks after the end of chemo-radiation. Those with a complete clinical response will be placed under a watch-and-wait protocol with digital rectal examinations every 2 months and pelvic MRI and sigmoidoscopy every 6 months. Those wih residual tumors will undergo resection with total mesorectal excision (TME). Patients with a "near complete response", as defined by a multidisciplinary tumor board, will be re-staged at week 16 or 18 after chemo-radiation before undergoing surgery. Adjuvant chemotherapy will be done following the local standard of care.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 150 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
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
Drug: Folfirinox
Standard post-radiation care
5-FU 2400mg/m2; Oxaliplatin 85 mg/m2, Irinotecan 150mg/m2
Also known as: mFOLFIRINOX, FOLFOXIRI, 5-FU, oxaliplatin, irinotecan
cCR + PathCR
Complete clinical response or pathological response
Time frame: 12 weeks after the end of chemoradiation
Rate of R0 resection
Rate of tumor resection with negative margins
Time frame: 12 weeks
Rate of organ preservation
Rate of patients who remain colostomy-free
Time frame: 6 months after surgery
Overall toxicity
Grade 3-4 toxicities according to CTCAE 4.0
Time frame: 12 weeks
Plan to share: No
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Folfirinox
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