Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resect… (NCT03085992) | Clinical Trial Compass
CompletedPhase 2
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer
Italy49 participantsStarted 2012-03
Plain-language summary
This study includes patients affected by advanced and resectable rectal adenocarcinoma. It provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free survival at two years. Translational analyses will be performed to show the presence of VEGF polymorphism, CD133 surface markers on colorectal CSCs.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Histologically proven diagnosis of rectal adenocarcinoma. Diagnosis obtained by a biopsy technique which leaves the major portion of the tumor intact.
* Locally advanced, resectable disease defined by the presence of at least one of the following features: tumour extending to within 1 mm of or beyond the mesorectal fascia (ie, circumferential radial margin threatened or involved); lower third (≤ 6 cm from the anal verge) cT3 tumours; tumour extending 5 mm or more into perirectal fat; T4 tumour (ie, invading surrounding structures or peritoneum); clinical stage III disease (T1-4, N1-2), with the definition of a clinically positive lymph node being any node ≥ 1.0 cm;
* Distal border of the tumor must be located \< 12 cm from the anal verge.
* No evidence of metastatic disease by CT scan of the chest and abdomen and total body PET-CT scan.
* Tumor must be amenable to curative resection (curative resection can include pelvic exenteration).
* No history of invasive rectal malignancy, regardless of disease-free interval.
* No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer.
* No clear indication of involvement of the pelvic side walls by imaging.
* Age between 18 and 75 years.
* ECOG Performance status \< 2 if age \< 70 years and = 0 if age 71-75 years.
* Life expectancy of at least 5 years (excluding diagnosis of cancer).
* Hematopoietic: absolute neutrophil count ≥ 1,00…