Spots Global Cancer Trial Database for Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer
Official Title: Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer. Phase II Randomized, Multicenter, Open Label Trial
Study ID: NCT02340949
Conditions
Study Description
Brief Summary: This trial compares induction treatment with FOLFOX with or without aflibercept in a high risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of pathologic complete response (pCR).
Detailed Description: This is a randomized trial comparing induction treatment with FOLFOX with or without aflibercept in a high risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery. Once it is confirmed that the subjects fulfill the eligibility criteria (MRI-defined high risk RC), and have signed the informed consent, a central review will be requested to confirm clinical stage, and then they will be randomized to receive mFOLFOX6 + Aflibercept or mFOLFOX6 (without Aflibercept). Random assignment of treatment will be stratified by T3 versus T4 stage. All the patients enrolled in the study will receive one cycle of study medication (mFOLFOX6 with or without aflibercept) every 14 days for six cycles, unless unacceptable toxicity or progression is detected. After this treatment, patients will receive standard chemo-radiotherapy (CT/RT) (capecitabine 825 mg/m2 twice daily combined with a total dose of 50.4 Gy in 28 days) followed by surgery, provided they have not progressed. Patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment. If a patient withdraws consent and refuses to receive further treatment, the patient must be followed up for 3 years from randomization or until progression, to evaluate disease-free survival. If a patient withdraws consent and refuses to continue in the study, the follow-up evaluations must be discontinued.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Carlos Fernández-Martos, MD
Affiliation: Fundación Instituto Valenciano de Oncología
Role: STUDY_DIRECTOR
Name: Antonieta Salud Salvia, MD
Affiliation: Hospital Universitari Arnau de Vilanova de Lleida
Role: PRINCIPAL_INVESTIGATOR
Name: Carles Pericay Pijaume, MD
Affiliation: Hospital de Sabadell - Parc Taulí
Role: PRINCIPAL_INVESTIGATOR
Name: Clara Montagut, MD
Affiliation: Hospital del Mar
Role: PRINCIPAL_INVESTIGATOR
Name: Joan Maurel Santasusana, MD
Affiliation: Hospital Clinic i provincial de Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: Vicente Alonso Orduña, MD
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: Ruth Vera García, MD
Affiliation: Complejo Hospitalario de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Gallego Plazas, MD
Affiliation: Hospital General Universitario de Elche
Role: PRINCIPAL_INVESTIGATOR
Name: Núria Rodríguez Salas, MD
Affiliation: Hospital Universitario La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Cubillo, MD
Affiliation: Hospital Universitario Madrid Sanchinarro (CIOCC)
Role: PRINCIPAL_INVESTIGATOR
Name: Bertomeu Massuti, MD
Affiliation: Hospital General Universitario de Alicante
Role: PRINCIPAL_INVESTIGATOR
Name: Ferrán Losa, MD
Affiliation: Hospital de Sant Joan Despí Moisés Broggi
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel Nogué, MD
Affiliation: Hospital General de Granollers
Role: PRINCIPAL_INVESTIGATOR
Name: Jaume Capdevila, MD
Affiliation: Hospital Universitari Vall d'Hebrón
Role: PRINCIPAL_INVESTIGATOR
Name: Isabel Busquier, MD
Affiliation: Consorcio Hospitalario Provincial de Castellón
Role: PRINCIPAL_INVESTIGATOR
Name: Inma Guash Jordan, MD
Affiliation: Fundación Althaia Manresa
Role: PRINCIPAL_INVESTIGATOR
Name: Laura Layos Romero, MD
Affiliation: Hospital Universitari Germans Trias i Pujol de Badalona
Role: PRINCIPAL_INVESTIGATOR
Name: Marta Martín-Richard, MD
Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: Rocio García Carbonero, MD
Affiliation: Hospital Universitario 12 de Octubre
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos López López, MD
Affiliation: Hospital Universitario Marqués de Valdecilla
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
