Spots Global Cancer Trial Database for Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma
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Trial Identification
Brief Title: Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma
Official Title: Phase II Randomized Trial to Evaluate Two Strategies: Continuing Versus Intermittent (Drug-holiday) Trabectedin-regimen in Patients With Advanced Soft Tissue Sarcoma Experiencing Response or Stable Disease After the Sixth Cycle
Study ID: NCT01303094
Study Description
Brief Summary: This randomization discontinuation trial will allow for concomitant evaluation of the following: * Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle * Side effects and benefits of a drug holiday
Detailed Description: Selection part (220 patients): Trabectedin (depending on dose reductions : between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression, intolerance or 6 cycles (according to the SPC of Trabectedin) Randomized part (50 patients): After the 6 first cycles, if there is not progression or unacceptable toxicity, the patients will be randomly assigned to continuous or "intermittent/holiday" therapy with CT-scan evaluation every 6 weeks in both arms * Arm A Continuation of Trabectedin (between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression or intolerance * Arm B "Intermittent/holiday" therapy. Rechallenge of Trabectedin will be implemented in the event of progression; in this case administration of Trabectedin will occur until the second progression or intolerance
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Saint-Jacques Hospital, Besancon, , France
Institut Bergonié, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont Ferrand, , France
Centre Georges François Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Léon Bérard Center, Lyon, , France
Centre Léon Bérard, Lyon, , France
Paoli Calmette Institute, Marseille, , France
CHU Timone Adultes, Marseille, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
Centre Henri Becquerel, Rouen, , France
Centre René Huguenin, St Cloud, , France
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Nicolas PENEL, MD, PhD
Affiliation: Centre Oscar Lambret
Role: PRINCIPAL_INVESTIGATOR
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