Locally Advanced Soft Tissue Sarcoma, Sarcoma Metastatic
Conditions
Keywords
Sarcoma, Advanced, Dematerialised, Care, Plan
Brief summary
ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP for patients with advanced sarcomas receiving systemic treatment. Participants will be randomised to an experimental group or a control group. Patients in the experimental group will receive the dematerialised PCP in addition to the standard PCP while patients in the control group will receive the standard PCP alone. All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.
Detailed description
ePPS-2202 is a phase 3, randomised,open-label, controlled, multicentre interventional study, designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP in patients with metastatic of locally advanced sarcomas with indication of a systemic treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine monotherapy. Participants will be randomised to the experimental arm or the control arm. Patients in the experimental arm will receive the dematerialised PCP in addition to the standard PCP while patients in the control arm will receive the standard PCP alone. All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up. The main analysis will compare the proportion of patients in each arm who experience at least one severe adverse event during the first 3 months of second-line treatment. Adverse events will be considered severe if they are graded 3 or higher according to NCI-CTCAE v5.0.
Interventions
OTHERDematerialized Personalized Care Plan (ePCP)
Post-treatment support with standard support combined with dematerialized support
Sponsors
Centre Oscar Lambret
Canceropôle Nord Ouest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sarcomas of soft tissues or viscera ; * Inoperable metastatic or locally advanced disease ; * Indication for systemic treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine monotherapy ; * Patient covered by French social security ; * Written, signed, informed consent ;
Exclusion criteria
* Prior inclusion in ePPS trial for a prior systemic treatment ; * Poor understanding of French ; * Difficulty accessing a computer ; * Pregnant or nursing woman ; * Person deprived of liberty or under guardianship ; * Impossibility of undergoing medical follow-up for geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe toxicity in the first 3 months of treatment | 3 months | Severe toxicity will be assessed through the reporting of adverse events (AE). Will be considered as an AE all indesirable medical event regardless of the cause, occurring between randomisation and the end of treatment + 30days or the start of a new systemic anti-cancer treatment or the 24-month follow-up. All AE grade ≥ 3 according to Common Terminology Criteria for Adverse Events v5.0 scale (NCI-CTCAE) will be considered severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 24 months | PFS will be defined as the time from randomisation to investigator-assessed disease progression (RECIST 1.1 or clinical). No progressive-patients will be censured at the 24-months follow-up. |
| Overall survival (OS) | 24 months | OS will be defined as the time from randomisation to patient's death regardless of the cause. Alive patients will be censured at the 24-month follow-up. |
| Severe toxicity | 24 months | Severe toxicity will be assessed through the reporting of adverse events (AE). Will be considered as an AE all indesirable medical event regardless of the relationship, occurring between randomization and the end of treatment + 30days or the stard of a new systemic anticancer treatment or the 24-month follow-up. All AE grade ≥ 3 according to Common Terminology Criteria for Adverse Events v5.0 scale (NCI-CTCAE) will be considered severe. |
| Nature of severe AEs | 24 months | Description of the nature of severe adverse events occuring between randomization and the end of treatment + 30days or the start of a new systemic anticancer treatment or the 24-month follow-up, especially: * Asthenia ; * Gastrointestinal disorders: vomiting, anorexia, mucositis/aphthosis, diarrhea, constipation; * Skin disorders: hand-foot syndrome, phototoxicity, dry skin skin dryness; * Hypertension; * Hematological toxicity ; * Hematuric cystitis with ifosfamide; * Ifosfamide encephalopathy; * Extravasation with trabectedine; |
| AEs leading to hospitalization | 24 months | Description of the adverse events leading to hospitalisation occuring between randomization and the end of treatment + 30days or the start of a new systemic anticancer treatment or the 24-month follow-up. |
| Survival weighted by quality of life | 24 months | Survival weighted by quality of life with the "Quality adjusted Time Without Symptoms and Toxicit" method (Q-Twist) |
| Quality of life assessed by EORTC QLQ-C30 questionnaire | 3 months | Quality of life assessed by "Quality of Life of Cancer Patients Questionnaire" (called EORTC QLQ-C30) at Baseline and at first oncological follow-up. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
Countries
France
Contacts
CONTACTPANNIER Diane, DR
CONTACTTHERY Julien, MD
PRINCIPAL_INVESTIGATORDiane PANNIER, MD
Centre Oscar Lambret
Outcome results
None listed