SHIVA02 - Evaluation of the Efficacy of Targeted Therapy Based on Tumor Molecular Profiling in Patients With Advanced Cancer Using Each Patient as Its Own Control (SHIVA02)

Not Applicable

Active, not recruiting

• Conditions: Cancer; Solid Tumor, Adult
• Interventions: Diagnostic Test: research of druggable molecular alterations on tumor biopsy

• Registration Number: NCT03084757
• Lead Sponsor: Institut Curie

Brief Summary

The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling versus conventional chemotherapy in patients with advanced cancer using each patient as its own control. This study is a study involving patients with advanced cancer. All types of solid tumors will be allowed in the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2017-05-26
• Primary Completion: 2022-10-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
research of druggable molecular alterations on tumor biopsy	research of druggable molecular alterations on tumor biopsy	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5.	3 years	PFS1 is defined as the time to a documented progression under conventional therapy according to RECIST 1.1. PFS2 is defined as the time to a documented progression or death when patients are treated by targeted therapy according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	3 years	Evaluation of overall survival (OS) defined as the time between inclusion and death, whatever the cause is. Alive patients will be censored at their last known contact date.
Ability of fine-needle aspiration cytology to detect molecular alterations identified on tumor biopsies	at baseline	Percentage of patients for whom all druggable molecular alterations detected on the tumor biopsy are also detected on fine-needle aspiration cytology
Overall response rate (ORR) on both treatments	3 years	Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1 The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
number of grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption	3 years	Evaluation of toxicities related to treatments according to CTCAE v4.03. Only grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption
Ability of ctDNA to detect molecular alterations identified on tumor biopsies	at baseline	Percentage of patients for whom all druggable molecular alterations detected on the tumor biopsy are also detected on ctDNA.
Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5, including patients who were treated with matched therapy based on a molecular alteration outside of RAF/MEK pathway	3 years	PFS1 is defined as the time to a documented progression under conventional therapy according to RECIST 1.1. PFS2 is defined as the time to a documented progression or death when patients are treated by targeted therapy according to RECIST 1.1
Ability of sequential ctDNA sampling to predict response/resistance to treatment	through study completion, every 2 months	Changes in ctDNA levels and molecular alterations observed at different time points.

Trial Locations

Locations (4)

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre LEON BERARD; 🇫🇷 Lyon, France

Institut Curie; 🇫🇷 Paris, France

Institut Curie Hôpital René Huguenin; 🇫🇷 Saint-Cloud, France