A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventio… (NCT01771458) | Clinical Trial Compass
CompletedPhase 2
A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer
France742 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient with recurrent/metastatic solid tumor who failed or are not candidate for treatments usually proposed in first intentions and for whom a prospective clinical trial has been indicated in a tumor board
✓. ECOG performance status of 0 or 1
✓. Biopsiable disease (tumor biopsy mandatory for tumor profiling). The biopsy can be performed when patients are being treated with standard therapy for their recurrent/metastatic cancer if it is not planned to treat them with molecularly targeted agents in the future.
✓. Measurable disease
✓. Adequate renal function defined by a serum creatinine \<1.5xUNL (upper normal limit)
✓. Adequate liver function test defined by SGOT \& SGPT \<3xUNL (5xUNL in case of liver metastases), and bilirubin level \<1.5xUNL
✓. Adequate bone marrow function defined by platelets \>100,000/mm3, hemoglobin \>10 g/dL, and neutrophils \>1,000/mm3
✓. Patients must be affiliated to the French Social Security System
Exclusion criteria
What they're measuring
1
Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy.
✕. 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
✕. Anticoagulation with anti-vitamin K (Low Molecular Weight Heparin \[LMWH\] is allowed)
✕. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including uncontrolled diabetes, cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infection within one year, chronic liver or renal disease, active gastrointestinal tract ulceration, severely impaired lung function
✕. Pregnant and/or breastfeeding women
✕. Individually deprived of liberty or placed under the authority of a tutor