The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
Patient is not a candidate for curative resection of metastatic lesions.
No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'

Criterios de exclusión

Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
Participation in another interventional study within 4 weeks prior to the randomisation .
Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
Symptomatic central nervous system metastases.
Major surgery within 4 weeks prior to the randomisation.
History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
Any contraindication present in the SmPC of trifluridine/tipiracil
Any contraindication present in the SmPC of bevacizumab
Any contraindication present in the SmPC of capecitabine

Intervenciones

drug

Trifluridine/tipiracil hydrochloride (S95005)

Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.

drug

Capecitabine

Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.

biological

Bevacizumab experimental

Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.

biological

Bevacizumab control

Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.

Ubicaciones

Centro de Oncología e Investigación de Buenos Aires COIBA

Berazategui, Argentina

Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

Buenos Aires, Argentina

Fundación Favaloro Oncology Unit

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

Buenos Aires, Argentina

Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, Argentina

Fundación COIR Centro Oncológico de Interación Regional

Mendoza, Argentina

Centro Médico San Roque

San Miguel de Tucumán, Argentina

Instituto de Oncología de Rosario

Santa Fe, Argentina

ISIS Centro especializado

Santa Fe, Argentina

An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Trifluridine/tipiracil hydrochloride (S95005)

Capecitabine

Bevacizumab experimental

Bevacizumab control

Ubicaciones

Centro de Oncología e Investigación de Buenos Aires COIBA

Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

Fundación Favaloro Oncology Unit

Instituto Alexander Fleming

Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer

Fundación COIR Centro Oncológico de Interación Regional

Centro Médico San Roque

Instituto de Oncología de Rosario

ISIS Centro especializado

Patrocinadores