Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum
NCT ID: NCT00909987
Last Updated: 2013-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2009-03-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
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.
Capecitabine
PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)
Oxaliplatin
IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)
Bevacizumab
IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)
Radiotherapy
Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).
Capecitabine during all Radiotherapy period
825 mg/m2 bid
Total Mesorectal Excision (TME)
4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after
Interventions
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Capecitabine
PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)
Oxaliplatin
IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)
Bevacizumab
IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)
Radiotherapy
Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).
Capecitabine during all Radiotherapy period
825 mg/m2 bid
Total Mesorectal Excision (TME)
4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor biopsy with histopathologic confirmation of rectal adenocarcinoma as primary histology
* Patient with measurable disease at the baseline visit
* T3 tumor that meets all the following criteria in high-resolution magnetic resonance imaging (MRI) (3-mm slices) of the pelvis: distal border of tumor more than 5cm form the external edge of the anus and below the sacral promontory (located in the anatomy rectum).
* Candidate for complete surgical resection (R0) with sphincter preservation surgery, prior to the administration of any therapy
* Candidate for systemic therapy with XELOX/BVZ
* ECOG: 0-2
* ANC≥1.5 cells/mm3, Hb\>8.0 g/dL, platelets\>150,000/mm3 in 2 previous weeks
* Patient who signed the informed consent
Exclusion Criteria
* Distant metastases
* Tumor with an intraperitoneal distal border
* Tumor presenting initially in a low location and judged, prior to any treatment, to require abdominoperineal resection
* Previous chemotherapy for colorectal cancer or incomplete recovery from oncologic surgery or other previous major surgery that, in the opinion of the investigator, precludes the use of a combined modality therapy
* Serum creatinine \<1.5 ULN
* Patient who has received previous pelvic radiotherapy
* Patient with an uncontrolled infection
* Presence of a high degree of obstruction (intestinal lumen ≤ 1 cm), unless the patient has undergone protective surgical bypass or an endoscopic stent procedure
* Pt with a history of an arterial thromboembolic event during the previous year.This includes angina (stable or unstable),myocardial infarction (MI),cerebrovascular accident (CVA),or other relevant history in the opinion of the investigator.Note: A patient with a history of thrombotic events, such as deep venous thrombosis, pulmonary embolism, MI or ACV, within the 6 months preceding recruitment may be considered for participation in the clinical trial if they are receiving stable doses of anticoagulant therapy. Similarly, patients being anticoagulated for atrial fibrillation or other conditions can participate if they are receiving a stable dosage of anticoagulant therapy. Clinicians must consider the higher risk of therapy with BVZ among patients with a history of thromboembolic disorders so the decision to allow the patients to participate remains at the discretion of the physician
* Previous treatment with another investigational antitumoral therapy in the 30 days prior to beginning treatment
* History of previous malignancy in the past 5 years, excepting basocellular or squamous cell skin cancer, or properly treated cervix cancer in situ
* Woman with a positive pregnancy test in urine or serum during recruitment, prior to the administration of the study medication, or within 72 hours of beginning to take the study medication, or a woman who is nursing
* WOCBP who does not wish to use or cannot use an effective contraceptive method to avoid pregnancy during the complete study period up to 4 weeks after ending the study.Male subjects also must agree to use an effective method of contraception.Note: WOCBP refers to any woman who has experienced menarche and has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea≥12 consecutive months,or women with hormonal replacement therapy and documented serum levels of follicle stimulating hormone).Even women who are using oral, implanted or injectable contraceptive hormones, mechanical products such as an intrauterine device or barrier methods to prevent pregnancy,or who practice abstinence or have a sterile partner, must be assumed to be WOCBP
* Patient with any other condition or concurrent medical or psychiatric disease who,in opinion of the investigator, is not eligible to enter the study
* Known hypersensitivity to any component of the study drug (XELOX/bevacizumab) or radiotherapy
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Grupo Espanol Multidisciplinario del Cancer Digestivo
OTHER
Responsible Party
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Principal Investigators
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Carlos Fernández Martos, Oncologist
Role: STUDY_CHAIR
Instituto Valenciano de Oncología (IVO)
Carles Pericay, Oncologist
Role: STUDY_DIRECTOR
Complejo Sanitario Parc Taulí
Antonieta Salud, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau de Villanova (Lérida)
Vicente Alonso, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Miguel Servet
María José Safont, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
Ruth Vera, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital de Navarra
Pilar Escudero, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario Lozano Blesa
Joan Maurel, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic i provincial de Barcelona
Jorge Aparicio, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital La Fe
Jaime Feliú, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital La Paz
Mengual, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Instituto Valenciano de Oncología (IVO)
Moisés Miraflores, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau de Vilanova (Lérida)
Martín Tejedor Gutierrez, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital Miguel Servet
Ana Hernández Machancoses, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
Fernando Arias de la Vega, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital de Navarra
Javier Valencia, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario Lozano Blesa
Carles Conill, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic i provincial de Barcelona
Alejandro Tormo Micó, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital La Fe
María Elena Sánchez Santos, Radiotherapy
Role: PRINCIPAL_INVESTIGATOR
Hospital La Paz
Jorge Campos, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Instituto Valenciano de Oncología (IVO)
Enrique Sierra Grañón, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau de Vilanova (Lérida)
Andrés Monzón, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Hospital Miguel Servet
José Vicente Roig, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
Javier Suárez Alecha, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Hospital de Navarra
Eloy Tejero, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario Lozano Blesa
Antonio Lazy, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic i provincial de Barcelona
Rafael Estevan, Surgeon
Role: STUDY_DIRECTOR
Hospital La Fe
Damián García Olmo, Surgeon
Role: PRINCIPAL_INVESTIGATOR
Hospital La Paz
Jesús Santos, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Instituto valenciano de Oncología (IVO)
Ana Darnell, Radiologist
Role: STUDY_DIRECTOR
Complejo Sanitario Parc Taulí
Luís Sarriá, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Miguel Servet
Vicente Martínez Sanjuán, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
Javier Jiménez, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital de Navarra
José Antonio Fernández Gómez, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario Lozano Blesa
Juan Ramón Ayuso, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic i provincial de Barcelona
Fernando Mas Estellés, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital La Fe
Paula Alegría Hidalgo, Radiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital La Paz
Anna Caltrava, Pathologist
Role: STUDY_DIRECTOR
Instituto Valenciano de Oncología (IVO)
Alex Casalots, Pathologist
Role: PRINCIPAL_INVESTIGATOR
Complejo Sanitario de Parc Taulí
Xavier Matias-Guiu Guia, Pathologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau de Vilanova (Lérida)
Carlos Hörndler, Pathologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Miguel Servet
Encarna Martínez, Pathologist
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
María Luisa Gómez Dorronsoro, Pathologist
Role: PRINCIPAL_INVESTIGATOR
Hospital de Navarra
Javier Ortego, Pathologist
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico Universitario Lozano Blesa
María José Artes, Pathologist
Role: PRINCIPAL_INVESTIGATOR
Hospital La Fe
Marta Martín Richard, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Manuel Gallén, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Javier Gallego, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Elche
Locations
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Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Complejo Sanitario Parc Taulí
Sabadell, Barcelona, Spain
Hospital Arnau de Vilanova
Lleida, Lérida, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital de Navarra
Pamplona, Pamplona, Spain
Hospital La Fe
Valencia, Valencia, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Valencia, Spain
Hospital General de Valencia
Valencia, Valencia, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
Countries
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References
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Fernandez-Martos C, Brown G, Estevan R, Salud A, Montagut C, Maurel J, Safont MJ, Aparicio J, Feliu J, Vera R, Alonso V, Gallego J, Martin M, Pera M, Sierra E, Serra J, Delgado S, Roig JV, Santos J, Pericay C. Preoperative chemotherapy in patients with intermediate-risk rectal adenocarcinoma selected by high-resolution magnetic resonance imaging: the GEMCAD 0801 Phase II Multicenter Trial. Oncologist. 2014 Oct;19(10):1042-3. doi: 10.1634/theoncologist.2014-0233. Epub 2014 Sep 10.
Other Identifiers
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GEMCAD-0801
Identifier Type: -
Identifier Source: org_study_id