Trabectedin Maintenance Post 1st-line in STS
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|ClinicalTrials.gov Identifier: NCT02929394|
Recruitment Status : Terminated (Poor accrual)
First Posted : October 11, 2016
Last Update Posted : September 2, 2020
Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma.
This is a prospective, multicenter, randomized, open label Phase III trial investigating whether a maintenance treatment with trabectedin, as compared to the observational approach, can prolong progression-free survival in patients with advanced, inoperable and/or metastatic STS after response or stabilisation during first line treatment with doxorubicin.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue||Drug: Trabectedin||Phase 3|
Progression free survival will be estimated by the Kaplan-Meier method. The median survival time and its associated 95% non-parametric CI will be provided. Rates at 3 month intervals will be estimated using the log-log transformation of the Kaplan-Meier estimates and the standard deviation of the Kaplan Meier estimate based on the Greenwood formula.
For the primary analysis, PFS from randomization will be compared between the two arms using the score test from a Cox proportional hazards model adjusted for histology (stratification factor). The corresponding estimate of the treatment effect (hazard ratio) and 95% CI will be provided.
Secondary analyses include:
- the primary comparison of PFS repeated using methods for interval-censored data to adjust for deviations from the planned imaging scheduled, if any.
- the above mentioned analyses performed for PFS measured from date of starting firstline doxorubicin treatment.
Overall survival and time to second progression (PFS2) measured from randomization and from starting firstline doxorubicin treatment will be estimated by the Kaplan-Meier method. The median times and their associated 95% non-parametric CI will be calculated. Rates at 3 month intervals will be estimated using the log-log transformation of the Kaplan-Meier estimates and the standard deviation of the Kaplan Meier estimate based on the Greenwood formula. They will be compared between the two arms using an adjusted Cox proportional hazards model; the corresponding estimates of the hazard ratio and 95% CI will be provided. The above mentioned PFS2 comparison will also be repeated using methods for interval-censored data.
The adverse events related to the treatment (excluding those declared not reasonably possibly related to the treatment, but including those with relationship not assessable) will be described in the safety population. Worst grade of the AEs will be tabulated. Whenever a CTCAE code exists, the grade will be displayed according to that system, otherwise the values will be coded in up to three categories as below lower limit of normal (LLN), within normal range, and above upper limit of normal (ULN), as deemed appropriate.
The percentage of patients presenting severe treatment-related AE (grade ≥ 3), of patients reported to have died of toxicity and of patients who stopped treatment due to toxicity will be calculated and the 95% confidence interval will be presented.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Therapy With Trabectedin Versus Observation After First Line Treatment With Doxorubicin of Patients With Advanced or Metastatic Soft Tissue Sarcoma.|
|Actual Study Start Date :||November 7, 2017|
|Actual Primary Completion Date :||June 5, 2020|
|Actual Study Completion Date :||June 5, 2020|
Active Comparator: investigational treatment
Trabectedin 1.2 mg/m² through a central venous catheter as an IV infusion over 24 hours every 4 weeks until disease progression (RECIST 1.1) or unacceptable toxicity.
Trabectedin 1.2 mg/m² through a central venous catheter as an IV infusion over 24 hours every 4 weeks until disease progression (RECIST 1.1) or unacceptable toxicity
Other Name: Yondelis
No Intervention: observation
Observation through clinical and radiological follow-up until disease progression (RECIST 1.1).
- progression-free survival [ Time Frame: until 3/4 years after randomization of the first patient ]The primary end-point is progression-free survival defined from randomization according to RECIST 1.1.
- Safety and tolerability (Common Toxicity Criteria CTCAE 4.0) [ Time Frame: until 3/4 years after randomization of the first patient ]
- Overall survival [ Time Frame: until 3/4 years after randomization of the first patient ]
- Time to second progression (PFS2) [ Time Frame: until 3/4 years after randomization of the first patient ]
- Health related quality of life (QLQ-C30) [ Time Frame: until 3/4 years after randomization of the first patient ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929394
|Bordeaux, France, 33076|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69008|
|Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone|
|Marseille, France, 13385|
|Paris, France, 75248|
|Villejuif, France, 94805|
|Medizinische Hochschule Hannover|
|Hannover, Germany, 30625|
|Mannheim, Germany, 68167|
|Leiden University Medical Center|
|Maria Sklodowska-Curie Memorial Cancer Centre|
|Warsaw, Poland, 02 781|
|Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals|
|Barcelona, Spain, 08907|
|Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)|
|Barcelona, Spain, 08916|
|Hospital Universitario San Carlos|
|Madrid, Spain, 28040|
|Royal Marsden Hospital - Chelsea, London|
|London, United Kingdom, SW3 6JJ|
|Study Chair:||Hans Gelderblom||Leiden University Medical Centre|