Sarcoma, Soft Tissue Clinical Trial
Official title:
Maintenance Therapy With Trabectedin Versus Observation After First Line Treatment With Doxorubicin of Patients With Advanced or Metastatic Soft Tissue Sarcoma.
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.
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.
;
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