Completed

SHIVAMolecular Profiling vs. Conventional Therapy in Refractory Cancer

Study Aim

This study aims to evaluate if targeted therapy based on molecular profiling improves progression-free survival compared to conventional chemotherapy in patients with refractory cancer.

What is being tested

Targeted therapy based on molecular profiling : Imatinib

+ Tumor biopsy

+ Targeted therapy based on molecular profiling : Everolimus

DrugProcedure

Who is being recruted

Neoplasm Metastasis+2

+ Neoplasms

+ Neoplastic Processes

Over 18 Years

+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: October 2012

See protocol details

Summary

Principal SponsorInstitut Curie

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

This study explores two different treatment strategies for patients with cancer that has not responded to standard treatments. The goal is to see if using personalized medicine, based on the unique genetic makeup of a patient's tumor, is more effective than traditional methods chosen by doctors. This approach might help in finding better treatment options for patients with cancers that are difficult to treat and have limited options. By comparing these two strategies, researchers aim to improve outcomes and offer more tailored treatment plans. Participants undergo a biopsy to get a detailed genetic profile of their tumor. Based on this information, they are assigned to either receive a targeted therapy specific to their tumor's genetic abnormalities or a conventional therapy chosen by their doctor. The study tracks how long patients live without their disease getting worse, with evaluations every two months. If the cancer progresses, patients have the option to switch to the alternate treatment strategy, providing another potential treatment avenue. This study helps determine which strategy might offer better control of cancer growth.

Official TitleA Randomized Proof-of-concept Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer.

NCT01771458

Principal SponsorInstitut Curie

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

742 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasm MetastasisNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

21 inclusion criteria required to participate

Identification of tumor molecular abnormalities for which the Therapeutic Decision Committee (TDC) recommends a molecularly targeted therapy available in the context of the trial (even if the molecular profile is incomplete)

Therapy recommended by the TDC is not approved for the patient's disease

ECOG performance status of 0 or 1

Adequate renal function defined by a serum creatinine <1.5xUNL

Show More Criteria

10 exclusion criteria prevent from participating

Patients who have only bone and/or brain metastases

Patients whose brain metastases have not been controlled for >3 months

Patient participating in another clinical trial with an experimental drug

Patients who are candidate to receive a molecularly targeted agent that is approved for their disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Targeted therapy based on the patient molecular profil (if there is at least one abnormality that could be targeted) Elligible therapies in this trial are : Imatinib Everolimus Vemurafenib Sorafenib Erlotinib Lapatinib Trastuzumab Dasatinib Tamoxifen (or letrozole if contra-indication) Abiraterone

Group II

Active Comparator

Treatment choice is based on Investigator decision.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Centre régional de lutte contre le cancer de Bourgogne Georges François Leclerc

Dijon, FranceOpen Centre régional de lutte contre le cancer de Bourgogne Georges François Leclerc in Google Maps

Suspended

Centre Leon Berard

Lyon, France

Suspended

Institut Paoli Calmettes

Marseille, France

Suspended

Insitut Curie

Paris, France

Completed8 Study Centers