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A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer

NCT01771458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 742

Last updated 2025-11-24

No results posted yet for this study

Summary

SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies for patients with refractory cancer.

From a tumor biopsy, a molecular profile of the disease is established (mutations, amplifications, hormone receptor status). If a molecular abnormality is identified for which an approved targeted agent is available, patients are randomized randomized between two arms:

* Targeted therapy based on the molecular profile
* Conventional therapy based on investigator's choice.

A cross-over is proposed at disease progression.

Conditions

  • Reccurent/Metastatic Solid Tumor Disease

Interventions

DRUG

Targeted therapy based on molecular profiling : Imatinib

PROCEDURE

Tumor biopsy

DRUG

Standard Chemotherapy

DRUG

Targeted therapy based on molecular profiling : Everolimus

DRUG

Targeted therapy based on molecular profiling : Vemurafenib

DRUG

Targeted therapy based on molecular profiling : Sorafenib

DRUG

Targeted therapy based on molecular profiling : Erlotinib

DRUG

Targeted therapy based on molecular profiling : Lapatinib + Trastuzumab

DRUG

Targeted therapy based on molecular profiling : Dasatinib

DRUG

Targeted therapy based on molecular profiling : Tamoxifen (or letrozole if contra-indication)

DRUG

Targeted therapy based on molecular profiling : Abiraterone

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Christophe LE TOURNEAU, MD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01771458 on ClinicalTrials.gov