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

NCT00909987 | Completed Phase 2

• 1 other identifier: GEMCAD-0801
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 12

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.

Conditions

Rectum Cancer

Keywords

rectum; intermediate risk cancer rectum; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria

  Until the end of study

Secondary Outcomes (6)

• Study treatment,which selectively omits neoadjuvant irradiation,can achieve a R0= 90%

  At least 3 years for local recurrence and systemic recurrence

• Rate of local and systemic recurrence

  At least 3 years for local recurrence and systemic recurrence

• Toxicity of treatment

  At least 3 years for local recurrence and systemic recurrence

• Rate of surgical complications during postoperative

  At least 3 years for local recurrence and systemic recurrence

• Profile of gene expression before neoadjuvant treatment

  At least 3 years for local recurrence and systemic recurrence

Study Arms (1)

Single arm

EXPERIMENTAL

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.

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab; Radiation: Radiotherapy; Drug: Capecitabine during all Radiotherapy period; Procedure: Total Mesorectal Excision (TME)

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

Single arm

Oxaliplatin DRUG

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

Single arm

Bevacizumab DRUG

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

Also known as: Avastin

Single arm

Radiotherapy RADIATION

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

Also known as: Neoadjuvant Radiotherapy

Single arm

Capecitabine during all Radiotherapy period DRUG

825 mg/m2 bid

Also known as: Xeloda

Single arm

Total Mesorectal Excision (TME) PROCEDURE

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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥18 years
• 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

You may not qualify if:

• Stage T4.
• 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

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (12)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Complejo Sanitario Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Arnau de Vilanova

Lleida, Lérida, 25198, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Hospital La Fe

Valencia, Valencia, 46009, Spain

Location

Instituto Valenciano de Oncología (IVO)

Valencia, Valencia, 46009, Spain

Location

Hospital General de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 25209376 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Bevacizumab; Radiotherapy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics; Combined Modality Therapy

Study Officials

• Carlos Fernández Martos, Oncologist

  Instituto Valenciano de Oncología (IVO)

  STUDY CHAIR

• Carles Pericay, Oncologist

  Complejo Sanitario Parc Taulí

  STUDY DIRECTOR

• Antonieta Salud, Oncologist

  Hospital Arnau de Villanova (Lérida)

  PRINCIPAL INVESTIGATOR

• Vicente Alonso, Oncologist

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• María José Safont, Oncologist

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Ruth Vera, Oncologist

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

• Pilar Escudero, Oncologist

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

• Joan Maurel, Oncologist

  Hospital Clinic i provincial de Barcelona

  PRINCIPAL INVESTIGATOR

• Jorge Aparicio, Oncologist

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

• Jaime Feliú, Oncologist

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

• Mengual, Radiotherapy

  Instituto Valenciano de Oncología (IVO)

  PRINCIPAL INVESTIGATOR

• Moisés Miraflores, Radiotherapy

  Hospital Arnau de Vilanova (Lérida)

  PRINCIPAL INVESTIGATOR

• Martín Tejedor Gutierrez, Radiotherapy

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Ana Hernández Machancoses, Radiotherapy

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Fernando Arias de la Vega, Radiotherapy

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

• Javier Valencia, Radiotherapy

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

• Carles Conill, Radiotherapy

  Hospital Clinic i provincial de Barcelona

  PRINCIPAL INVESTIGATOR

• Alejandro Tormo Micó, Radiotherapy

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

• María Elena Sánchez Santos, Radiotherapy

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

• Jorge Campos, Surgeon

  Instituto Valenciano de Oncología (IVO)

  PRINCIPAL INVESTIGATOR

• Enrique Sierra Grañón, Surgeon

  Hospital Arnau de Vilanova (Lérida)

  PRINCIPAL INVESTIGATOR

• Andrés Monzón, Surgeon

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• José Vicente Roig, Surgeon

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Javier Suárez Alecha, Surgeon

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

• Eloy Tejero, Surgeon

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

• Antonio Lazy, Surgeon

  Hospital Clinic i provincial de Barcelona

  PRINCIPAL INVESTIGATOR

• Rafael Estevan, Surgeon

  Hospital La Fe

  STUDY DIRECTOR

• Damián García Olmo, Surgeon

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

• Jesús Santos, Radiologist

  Instituto valenciano de Oncología (IVO)

  PRINCIPAL INVESTIGATOR

• Ana Darnell, Radiologist

  Complejo Sanitario Parc Taulí

  STUDY DIRECTOR

• Luís Sarriá, Radiologist

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Vicente Martínez Sanjuán, Radiologist

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Javier Jiménez, Radiologist

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

• José Antonio Fernández Gómez, Radiologist

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

• Juan Ramón Ayuso, Radiologist

  Hospital Clinic i provincial de Barcelona

  PRINCIPAL INVESTIGATOR

• Fernando Mas Estellés, Radiologist

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

• Paula Alegría Hidalgo, Radiologist

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

• Anna Caltrava, Pathologist

  Instituto Valenciano de Oncología (IVO)

  STUDY DIRECTOR

• Alex Casalots, Pathologist

  Complejo Sanitario de Parc Taulí

  PRINCIPAL INVESTIGATOR

• Xavier Matias-Guiu Guia, Pathologist

  Hospital Arnau de Vilanova (Lérida)

  PRINCIPAL INVESTIGATOR

• Carlos Hörndler, Pathologist

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Encarna Martínez, Pathologist

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• María Luisa Gómez Dorronsoro, Pathologist

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

• Javier Ortego, Pathologist

  Hospital Clinico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

• María José Artes, Pathologist

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

• Marta Martín Richard, Oncologist

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

• Manuel Gallén, Oncologist

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Javier Gallego, Oncologist

  Hospital General Universitario de Elche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: May 29, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-09

Locations

ES (12)