Etude : SUNLIGHT /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : SUNLIGHT

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Thérapie ciblée

Cadre réglementaire : RIPH2

Dernière MÀJ : 15/10/2021
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III comparant le trifluridine/tipiracil en association avec le bévacizumab au trifluridine/tipiracil en monothérapie chez des patients atteints d'un cancer colorectal métastatique réfractaire

Spécialité : Organes digestifs
Localisation : C18 - Tumeur maligne du côlon

Spécialité : Organes digestifs
Localisation : C19 - Tumeur maligne de la jonction recto-sigmoïdienne

Spécialité : Organes digestifs
Localisation : C20 - Tumeur maligne du rectum
Informations complémentaires
Schéma : This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm).

2 arms:
- Experimental: trifluridine/tipiracil in combination with bevacizumab
- Active Comparator: trifluridine/tipiracil monotherapy

Phase : III

Stade : Métastatique

3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
- RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy.
- Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.
- Has measurable or non-measurable disease as defined by RECIST version 1.1
- Is able to swallow oral tablets.
- Estimated life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

Critères de non-inclusion : - More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer.
- Pregnancy, lactating female or possibility of becoming pregnant during the study.
- Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization.
- Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation).
- Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- Has severe or uncontrolled active acute or chronic infection.
- Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
- Known Hepatitis B or Hepatitis C Virus infection.
- Known carriers of HIV antibodies.
- Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia.
- Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization.
- Treatment with any of the following within the specified time frame prior to randomization:
-> major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
-> Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only.
-> Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization
- Other clinically significant medical conditions.
- Other malignancies.
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt :

Investigateur :
Marie-Pierre GALAIS

Corentin LE GALLIC

Statut de l'essai : CLOS

MAJ : 15/10/2021