Etude : RASINTRO /

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

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 04/12/2019
CIM10 - Localisation(s)
Informations principales
Titre : Predictive Impact of RAS Mutations in Circulating Tumor DNA for Efficacy of Anti-EGFR Reintroduction Treatment in Patients With Metastatic Colorectal Cancer

Spécialité : Organes digestifs
Localisation : C18 - Tumeur maligne du côlon
Informations complémentaires
Schéma : Brief Summary:
Some data have suggested a clinical survival benefit related to the reintroduction of anti-EGFRs therapy in patients with metastatic colorectal cancer (mCRC). Based on resistance mechanisms related to the development of resistant clones, the investigators could assume that patients who benefited most from the reintroduction of anti-EGFRs were those who, through interval chemotherapy, had no longer mutated RAS clone in plasma that appeared during the progression with the first anti-EGFR treatment. Conversely, those who did not benefit from this therapy were probably patients who had mutated RAS clones circulating at the time of reintroduction of anti-EGFRs. To support this hypothesis, investigators propose to evaluate the correlation between the eventual presence of RAS mutations in circulating blood and the efficacy of an anti-EGFR therapy reintroduction in patients with mCRC.

Samples With DNA

Circulating tumor DNA
During the inclusion period, a blood sample will be taken just before the first 3 cycles of chemotherapy (C1, C2 and C3) and at tumor progression for mCRC patients treated in one of the participating AGEO centers. These samples will not require any additional invasive procedures since they will be made from the Huber needle previously implanted in the catheter for previously scheduled chemotherapy cycles.

The patient will sign an information letter and a specific informed consent for blood collection and biological studies. In case of specific refusal, the patient will not be included.

Phase : NA

Stade : Métastasique

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 : Age ≥18 years
Metastatic colorectal cancer histological confirmed without somatic mutations of KRAS (exons 2, 3 et 4) and NRAS (exons 2, 3 et 4)
Apart from contraindication, patients should have already received fluoropyrimidine, irinotecan, oxaliplatin, anti-EGFR (panitumumab or cetuximab) and anti-angiogenic (bevacizumab or aflibercept) therapies
Previous treatment with anti-EGFR-based chemotherapy (panitumumab or cetuximab) should have provided an objective tumor response (according to RECIST 1.1 criteria) and/or PFS ≥ 4 months.
At least one line of interval chemotherapy between the last cycle of anti-EGFR based treatment and reintroduction of anti-EGFR therapy
Signed written informed consent obtained prior to any study specific screening procedures

Critères de non-inclusion : Discontinuation of first anti-EGFR therapy for other reasons than tumor progression
Previous malignancy other than colorectal cancer in the last 5 years
Medical, sociological, psychological or legal conditions that would not permit the patient to sign the informed consent
Informations relatives au promoteur
Promoteur :
Association des Gastroentérologues Oncologues (AGEO)
Type de sponsor : Institutionnel
16 rue des Tanneries, 75013, Paris.
75013 PARIS 13

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Pas d'investigateur principal

Patricia FOSSE
02 32 88 86 10 poste 64 462

Statut de l'essai : OUVERT

MAJ : 04/12/2019