Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Second Line Treatment. (ePPS-2202)

Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Second Line Treatment.

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 second-line 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma Metastatic; Locally Advanced Soft Tissue Sarcoma
• Intervention / Treatment: Other: Dematerialized Personalized Care Plan (ePCP)

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 second-line treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine after failure of a first-line anthracycline-based regimen.

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.

• Study Type: Interventional
• Enrollment (Estimated): 377
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PANNIER Diane, DR; Phone Number: 03.20.29.59.59; Email: d-pannier@o-lambret.fr
• Study Contact Backup: Name: THERY Julien, MD; Email: J-THERY@o-lambret.fr

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69373
      • Centre Leon Berard
      • Contact: Armelle DUFRESNE, MD; Phone Number: +33 (0) 4 69 85 61 47; Email: armelle.dufresne@lyon-unicancer.fr
      • Principal Investigator: Armelle DUFRESNE, MD
  • Bourgogne-Franche-Comté
    • Besançon, Bourgogne-Franche-Comté, France, 25000
      • CHU Jean Minjoz
      • Contact: Loic CHAIGNEAU, MD; Phone Number: +33 (0) 3 70 63 20 05; Email: lchaigneau@chu-besancon.fr
      • Principal Investigator: Loic CHAIGNEAU, MD
  • Bretagne
    • Rennes, Bretagne, France, 35042
      • Centre Eugene Marquis
      • Contact: Perrine VUAGNAT, MD; Phone Number: +33 (0) 2 99 25 29 69; Email: p.vuagnat@rennes.unicancer.fr
      • Principal Investigator: Perrine VUAGNAT, MD
  • Grand Est
    • Strasbourg, Grand Est, France, 67033
      • Institut de Cancerologie Strasbourg
      • Contact: Sophie MARTIN, MD; Phone Number: +33 (0) 3 68 76 72 07; Email: s.martin@icans.eu
      • Principal Investigator: Sophie MARTIN, MD
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59020
      • Centre Oscar Lambret
      • Contact: Diane PANNIER, MD; Phone Number: +33 (0) 3 20 29 59 59; Email: d-pannier@o-lambret.fr
      • Principal Investigator: Diane PANNIER, MD
  • Nouvelle-Aquitaine
    • Poitiers, Nouvelle-Aquitaine, France, 86021
      • CHU de Poitiers
      • Contact: Marjorie HIRSCH, MD; Phone Number: +33 (0) 5 49 44 07 11; Email: marjorie.hirsch@chu-poitiers.fr
      • Principal Investigator: Marjorie HIRSCH, MD
  • Occitanie
    • Toulouse, Occitanie, France, 31059
      • Institut Claudius Regaud
      • Principal Investigator: Thibaud VALENTIN, MD
      • Contact: Thibaud VALENTIN, MD; Phone Number: +33 (0) 5 31 15 51 51; Email: valentin.thibaud@iuct-oncopole.fr
  • Pays De La Loire
    • Saint-Herblain, Pays De La Loire, France, 44805
      • Institut de Cancérologie de l'Ouest
      • Principal Investigator: Emmanuelle BOMPAS, MD
      • Contact: Emmanuelle BOMPAS, MD; Phone Number: +33 (0) 2 40 67 99 00; Email: emmanuelle.bompas@ico.unicancer.fr
  • Île-de-France
    • Paris, Île-de-France, France, 75013
      • Hôpital Pitié-Salpêtrière AP-HP
      • Principal Investigator: Aurore Vozy, MD
      • Contact: Aurore VOZY, MD; Phone Number: +33 (0) 1 42 16 05 08; Email: aurore.vozy@aphp.fr
    • Villejuif, Île-de-France, France, 94800
      • Gustave Roussy
      • Principal Investigator: Benjamin VERRET, MD
      • Contact: Benjamin VERRET, MD; Phone Number: +33 (0) 1 42 11 42 11; Email: benjamin.verret@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sarcomas of soft tissues or viscera ;
• Inoperable metastatic or locally advanced disease ;
• Indication for 2nd-line treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine after failure of 1st-line anthracycline therapy ;
• Patient covered by French social security ;
• Written, signed, informed consent ;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group : standard PCP; Patient will receive standard support PCP
Experimental: Experimental group : demateralized PCP; Patient will receive standard support PCP and dematerialized PCP (ePCP)	Other: Dematerialized Personalized Care Plan (ePCP); Post-treatment support with standard support combined with dematerialized support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe toxicity in the first 3 months of treatment	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	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.	24 months
Overall survival (OS)	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.	24 months
Nature of severe AEs	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;	24 months
AEs leading to hospitalization	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.	24 months
Severe toxicity	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.	24 months
Survival weighted by quality of life	Survival weighted by quality of life with the "Quality adjusted Time Without Symptoms and Toxicit" method (Q-Twist)	24 months

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Canceropôle Nord Ouest
• Investigators: Principal Investigator: Diane PANNIER, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Advanced; Care; Sarcoma; Plan; Dematerialised
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: ePPS-2202; 2023-A00984-41 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No