Spots Global Cancer Trial Database for Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum
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Trial Identification
Brief Title: Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum
Official Title: Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging
Study ID: NCT00909987
Conditions
Study Description
Brief Summary: Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.
Detailed Description: XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX without Bevacizumab will be administrated for an additional cycle over a 4 week period. Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous Capecitabine.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital General Universitario de Elche, Elche, Alicante, Spain
Complejo Sanitario Parc TaulĂ, Sabadell, Barcelona, Spain
Hospital del Mar, Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Arnau de Vilanova, LĂ©rida, , Spain
Hospital La Paz, Madrid, , Spain
Hospital de Navarra, Pamplona, , Spain
Hospital La Fe, Valencia, , Spain
Instituto Valenciano de OncologĂa (IVO), Valencia, , Spain
Hospital General de Valencia, Valencia, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Carlos FernĂĄndez Martos, Oncologist
Affiliation: Instituto Valenciano de OncologĂa (IVO)
Role: STUDY_CHAIR
Name: Carles Pericay, Oncologist
Affiliation: Complejo Sanitario Parc TaulĂ
Role: STUDY_DIRECTOR
Name: Antonieta Salud, Oncologist
Affiliation: Hospital Arnau de Villanova (LĂ©rida)
Role: PRINCIPAL_INVESTIGATOR
Name: Vicente Alonso, Oncologist
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: MarĂa JosĂ© Safont, Oncologist
Affiliation: Hospital General Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Ruth Vera, Oncologist
Affiliation: Hospital de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Pilar Escudero, Oncologist
Affiliation: Hospital ClĂnico Universitario Lozano Blesa
Role: PRINCIPAL_INVESTIGATOR
Name: Joan Maurel, Oncologist
Affiliation: Hospital Clinic i provincial de Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: Jorge Aparicio, Oncologist
Affiliation: Hospital La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: Jaime FeliĂș, Oncologist
Affiliation: Hospital La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Mengual, Radiotherapy
Affiliation: Instituto Valenciano de OncologĂa (IVO)
Role: PRINCIPAL_INVESTIGATOR
Name: Moisés Miraflores, Radiotherapy
Affiliation: Hospital Arnau de Vilanova (LĂ©rida)
Role: PRINCIPAL_INVESTIGATOR
Name: MartĂn Tejedor Gutierrez, Radiotherapy
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: Ana HernĂĄndez Machancoses, Radiotherapy
Affiliation: Hospital General Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Fernando Arias de la Vega, Radiotherapy
Affiliation: Hospital de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Valencia, Radiotherapy
Affiliation: Hospital ClĂnico Universitario Lozano Blesa
Role: PRINCIPAL_INVESTIGATOR
Name: Carles Conill, Radiotherapy
Affiliation: Hospital Clinic i provincial de Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: Alejandro Tormo MicĂł, Radiotherapy
Affiliation: Hospital La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: MarĂa Elena SĂĄnchez Santos, Radiotherapy
Affiliation: Hospital La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Jorge Campos, Surgeon
Affiliation: Instituto Valenciano de OncologĂa (IVO)
Role: PRINCIPAL_INVESTIGATOR
Name: Enrique Sierra Grañón, Surgeon
Affiliation: Hospital Arnau de Vilanova (LĂ©rida)
Role: PRINCIPAL_INVESTIGATOR
Name: Andrés Monzón, Surgeon
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: José Vicente Roig, Surgeon
Affiliation: Hospital General Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Javier SuĂĄrez Alecha, Surgeon
Affiliation: Hospital de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Eloy Tejero, Surgeon
Affiliation: Hospital ClĂnico Universitario Lozano Blesa
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Lazy, Surgeon
Affiliation: Hospital Clinic i provincial de Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: Rafael Estevan, Surgeon
Affiliation: Hospital La Fe
Role: STUDY_DIRECTOR
Name: DamiĂĄn GarcĂa Olmo, Surgeon
Affiliation: Hospital La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: JesĂșs Santos, Radiologist
Affiliation: Instituto valenciano de OncologĂa (IVO)
Role: PRINCIPAL_INVESTIGATOR
Name: Ana Darnell, Radiologist
Affiliation: Complejo Sanitario Parc TaulĂ
Role: STUDY_DIRECTOR
Name: LuĂs SarriĂĄ, Radiologist
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: Vicente MartĂnez SanjuĂĄn, Radiologist
Affiliation: Hospital General Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Jiménez, Radiologist
Affiliation: Hospital de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: José Antonio Fernåndez Gómez, Radiologist
Affiliation: Hospital ClĂnico Universitario Lozano Blesa
Role: PRINCIPAL_INVESTIGATOR
Name: Juan RamĂłn Ayuso, Radiologist
Affiliation: Hospital Clinic i provincial de Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: Fernando Mas Estellés, Radiologist
Affiliation: Hospital La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: Paula AlegrĂa Hidalgo, Radiologist
Affiliation: Hospital La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Anna Caltrava, Pathologist
Affiliation: Instituto Valenciano de OncologĂa (IVO)
Role: STUDY_DIRECTOR
Name: Alex Casalots, Pathologist
Affiliation: Complejo Sanitario de Parc TaulĂ
Role: PRINCIPAL_INVESTIGATOR
Name: Xavier Matias-Guiu Guia, Pathologist
Affiliation: Hospital Arnau de Vilanova (LĂ©rida)
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Hörndler, Pathologist
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: Encarna MartĂnez, Pathologist
Affiliation: Hospital General Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: MarĂa Luisa GĂłmez Dorronsoro, Pathologist
Affiliation: Hospital de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Ortego, Pathologist
Affiliation: Hospital Clinico Universitario Lozano Blesa
Role: PRINCIPAL_INVESTIGATOR
Name: MarĂa JosĂ© Artes, Pathologist
Affiliation: Hospital La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: Marta MartĂn Richard, Oncologist
Affiliation: Hospital Santa Creu i Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: Manuel Gallén, Oncologist
Affiliation: Hospital del Mar
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Gallego, Oncologist
Affiliation: Hospital General Universitario de Elche
Role: PRINCIPAL_INVESTIGATOR
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