Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Bevacizumab

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Neoadyuvant chemotherapy with XELOX: Xeloda 1000mg/m2/12h dayly, day one in the afternoon until day 15 in the morning; plus oxaliplatin 130mg/m2 (day 1); and Bevacizumab 7.5 mg/kg (day 1)during 3 cycles (each cycle of 3 weeks).

Followed by a selective use of chemoradiotherapy with radiotherapy (50.4Gy, 28 sesions of 1.8Gy during 5 weeks) plus Xeloda 825mg/m2/12h dayly.

PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)

IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)

IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)

Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).

Radiotherapy

Capecitabine during all Radiotherapy period

4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after

Total Mesorectal Excision (TME)

Carlos Fernández Martos, Oncologist

Carles Pericay, Oncologist

Antonieta Salud, Oncologist

Vicente Alonso, Oncologist

María José Safont, Oncologist

Ruth Vera, Oncologist

Pilar Escudero, Oncologist

Joan Maurel, Oncologist

Jorge Aparicio, Oncologist

Jaime Feliú, Oncologist

Mengual, Radiotherapy

Moisés Miraflores, Radiotherapy

Martín Tejedor Gutierrez, Radiotherapy

Ana Hernández Machancoses, Radiotherapy

Fernando Arias de la Vega, Radiotherapy

Javier Valencia, Radiotherapy

Carles Conill, Radiotherapy

Alejandro Tormo Micó, Radiotherapy

María Elena Sánchez Santos, Radiotherapy

Jorge Campos, Surgeon

Enrique Sierra Grañón, Surgeon

Andrés Monzón, Surgeon

José Vicente Roig, Surgeon

Javier Suárez Alecha, Surgeon

Eloy Tejero, Surgeon

Antonio Lazy, Surgeon

Rafael Estevan, Surgeon

Damián García Olmo, Surgeon

Jesús Santos, Radiologist

Ana Darnell, Radiologist

Luís Sarriá, Radiologist

Vicente Martínez Sanjuán, Radiologist

Javier Jiménez, Radiologist

José Antonio Fernández Gómez, Radiologist

Juan Ramón Ayuso, Radiologist

Fernando Mas Estellés, Radiologist

Paula Alegría Hidalgo, Radiologist

Anna Caltrava, Pathologist

Alex Casalots, Pathologist

Xavier Matias-Guiu Guia, Pathologist

Carlos Hörndler, Pathologist

Encarna Martínez, Pathologist

María Luisa Gómez Dorronsoro, Pathologist

Javier Ortego, Pathologist

María José Artes, Pathologist

Marta Martín Richard, Oncologist

Manuel Gallén, Oncologist

Javier Gallego, Oncologist

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.

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.

Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

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

Complete pathologic response (pCR)estimated according to the number of subjects that showed yPT0N0 divided by the total number of subjects.

Royal Marsden NHS Foundation Trust

Grupo Espanol Multidisciplinario del Cancer Digestivo

Spots Global Cancer Trial Database for intermediate risk cancer rectum