Rectal cancer MedDRA version: 20.0 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ONIVYDE 5 mg/ml concentrado para solución para perfusión
Product Name: irinotecan liposome injection
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IRINOTE
Sponsors
Fundación de investigación de HM Hospitales
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or females, aged > or = 18 years. 2. Agree to participate and sign voluntary written ICF before any study specific procedure. 3. Patients with confirmed histopathological diagnosis of rectal cancer. 4. Patients with locally advanced rectal cancer T3-T4N0M0 or TxN+M0 and selected T2N0M0 candidates to watch & wait program. 5. Patients considered for neoadjuvant treatment according to usual clinical practice may also be potential candidates. 6. ECOG performance status 0 or 1. 7. Patients who can receive radiotherapy and chemotherapy. 8. No prior or concurrent malignant disease unless in complete remission for more than three years, except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma or in situ transitional bladder cell carcinoma. 9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test before study entry. Both women and men must agree to use a highly effective contraceptive measure throughout the treatment period and for six months after discontinuation of treatment. 10. Adequate hematologic function 11. Adequate hepatic function 12. Adequate renal function 13. No peripheral neuropathy (=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Patients with ECOG performance status > or =2. 2. T1N0M0)or stage IV (TxNxM1) AJCC rectal cancer. 3. Any illness that the investigator considers will substantially increase the risk if the patient participates in the study. 4. Pregnant or breast-feeding woman. 5. Chronically active hepatitis B or C virus infection. 6. Active uncontrolled infection. 7. History, within last year, or presence of unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic left ventricular ejection fraction Grade 1) 9. Known history of dihydropyrimidine dehydrogenase deficiency (DPD) 10. Known or suspected reactions to any component of the study medication (5-FU, leucovorin, irinotecan or oxaliplatin) or to components of similar chemical or biologic composition. 11. Any phycological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule. 12. Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule. 13. Patients that had received any previous treatment for their rectal cancer (surgery, chemotherapy or radiotherapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of neoadjuvant chemotherapy combination (5FU/LV + Oxaliplatin + nal-IRI) to determine the percentage of clinical responses after neoadjuvant treatment in patients with LARC.;Secondary Objective: - Safety profile of neoadjuvant chemotherapy combination (5FU/LV + Oxaliplatin + Nal-IRI). - Efficacy in terms of OS, PFS and assessment of patients that will be able to go on a “watch-and-wait” strategy;Primary end point(s): cCR rate (ycT0N0) in LARC patients treated with chemo - chemoradiation.;Timepoint(s) of evaluation of this end point: at 7-8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • Overall survival: will be determined from the initiation date of chemotherapy treatment to the date of death from any cause. • Relapse-free survival or disease-free survival: will be determined by the length of time after chemo – chemoradiotherapy treatment during which no disease is found. Patient survives without any signs and symptoms of the cancer. • Percentage of patients that follow the “watch-and-wait” surveillance protocol. Safety: • Overall toxicity: acute and late toxicity of neoadjuvant treatment (chemo and chemoradiotherapy) according to the Common Toxicity Criteria (CTC) for adverse events (AE).;Timepoint(s) of evaluation of this end point: Efficacy: Through the study Safety: Through the study | — |
Countries
Spain
Contacts
Public ContactSecretaría
Fundación de investigación de HM Hospitales
Outcome results
None listed