Induction Therapy With Panitumumab + mFOLFOX-6 in Rectal Cancer and Quadruple Wild-type Mutation Before Surgery
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance
      imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for
      preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of
      panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response
      (pCR)
    

Detailed description: 
      Phase II, nonrandomized single-arm trial of preoperative treatment with mFOLFOX-6 and
      panitumumab in an enriched population of patients with rectal adenocarcinoma of intermediate
      risk, screened by MRI, without mutations in KRAS, BRAF, NRAS and PI3K. All patients enrolled
      in the study will receive 12 weeks of the investigational product (mFOLFOX-6 with
      panitumumab) every 14 days for six cycles, unless unacceptable toxicity occurs or progression
      is detected. After this treatment, response will be evaluated by diffusion-weighted MRI and
      endoscopy. In the absence of disease progression, patients eligible for R0 resection will
      undergo total mesorectal excision (TME). After surgery, patients will receive mFOLFOX6 x 6
      cycles. In the case of intolerance to FOLFOX-panitumumab, disease progression or
      ineligibility for R0 resection, patients will receive chemoradiotherapy with capecitabine 825
      mg/m2 every 12 hours concomitantly with radiotherapy (RT) with a total dose of 50.4 Gy. At
      the end of this treatment, patients will undergo TME between 6-8 weeks after finishing the
      CRT. If a patient has received 4 or more neoadjuvant cycles of FOLFOX-panitumumab before
      unacceptable toxicity or progression, it will be considered that the neoadjuvant treatment
      has been completed and the patient will have no additional neoadjuvant treatment but surgery.
      If the patient has received <4 cycles of neoadjuvant treatment, neoadjuvant CRT will be
      administered.

      If a patient has an acceptable toxicity or disease progression or a R0 surgery is not
      possible to be performed and the patient received CRT, the patient will be followed up for 24
      months, from the enrollment of the last patient in the trial, or until progression occurs, in
      order to assess progression-free survival and all the data regarding surgery and CRT will be
      recorded in the eCRF. If a patient withdraws consent and refuses to continue participating in
      the study, follow-up evaluations must be discontinued.
    

Intervention name(s): Panitumumab; 5Fluorouracil; Oxaliplatin; Leucovorin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.; Once every 14 days. Day 1: 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².; Once every 14 days. Day 1: 85 mg/m2 I.V. infusión in 250-500 mL, over two hours, followed by 5-FU; Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU
Other intervention name(s): Vectibix 20 mg/ml; 5-FU; Any marketed; Any marketed
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment