SHIVA
A Randomized Proof-of-concept Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer.
Sponsor study identifier
interventional
742
1 country
8
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 27, 2012
Actual (reported)January 18, 2013
Actual (reported)October 2016
Actual (reported)December 2016
Actual (reported)Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy.
Tumor evaluation according to RECIST 1.1 criteria (every 2 months)
Overall response rate (ORR)
Overall Survival (OS)
Treatments side effects assessement according to the NCI CTCAE v4.03 scale.
Treatment effect variations as defined by tumor growth according to the altered signaling pathway
Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy after cross-over.
Treatment choice is based on Investigator decision.
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Targeted therapy based on molecular profiling : Lapatinib + Trastuzumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCentre régional de lutte contre le cancer de Bourgogne Georges François Leclerc
Dijon, 21079, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
Insitut Curie
Paris, 75248, France
Institut Curie Hopital Rene Huguenin
Saint-Cloud, 92210, France
Institut de cancérologie de l'Ouest Centre René Gauducheau
Saint-Herblain, 44000, France
Institut Claudius Régaud
Toulouse, 31052, France
Belin L, Kamal M, Mauborgne C, Plancher C, Mulot F, Delord JP, Goncalves A, Gavoille C, Dubot C, Isambert N, Campone M, Tredan O, Ricci F, Alt M, Loirat D, Sablin MP, Paoletti X, Servois V, Le Tourneau C. Randomized phase II trial comparing molecularly targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer: cross-over analysis from the SHIVA trial. Ann Oncol. 2017 Mar 1;28(3):590-596. doi: 10.1093/annonc/mdw666.
Le Tourneau C, Delord JP, Goncalves A, Gavoille C, Dubot C, Isambert N, Campone M, Tredan O, Massiani MA, Mauborgne C, Armanet S, Servant N, Bieche I, Bernard V, Gentien D, Jezequel P, Attignon V, Boyault S, Vincent-Salomon A, Servois V, Sablin MP, Kamal M, Paoletti X; SHIVA investigators. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015 Oct;16(13):1324-34. doi: 10.1016/S1470-2045(15)00188-6. Epub 2015 Sep 3.
Christophe LE TOURNEAU, MD
Institut Curie
742 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2012
First Posted
January 18, 2013
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
Primary Completion
October 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
November 24, 2025
Record last verified: 2025-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: