Assessment of MGMT Promoter Methylation in Advanced Ewing Sarcoma Treated With Temozolomide and Irinotecan

Completed

• Conditions: Ewing Sarcoma Family of Tumors
• Interventions: Other: MGMT methylation evaluation

• Registration Number: NCT03542097
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan The O6-methylguanine-DNA methyltransferase (MGMT) methylation status, will be correlated with the disease clinical data and with the disease response

Detailed Description

This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan.

The MGMT methylation status will be correlated with the disease clinical data and with the disease response also in term of metabolic activity (if data will be available) The MGMT methylation analysis will be performed extracting from fresh tumor sample, the DNA on the basis of the standard protocols.

Study Timeline

• Study Start: 2014-04-15
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Histological confirmed diagnosis of Ewing Sarcoma
2. Chemotherapic treatment with temozolomide and irinotecan
3. Written informed consent prior to any study related activities

Exclusion Criteria

1. Lack of written informed consent for the study
2. Any situation that could interfere with the complete data collection of the clinical data related to the temozolomide and irinotecan treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Temozolomide and Irinotecan treatment	MGMT methylation evaluation	The group include all the patients with histological confirmed diagnosis of Ewing's Sarcoma who received chemotherapic treatment with temozolomide and irinotecan. In this group the MGMT methylation evaluation will be done

Primary Outcome Measures

Name	Time	Method
Assessment of MGMT promoter methylation	at day 1	Amplification the methylation-specific Polymerase Chain Reaction products will be electrophoresed on a 2% agarose gel and will visualized with UV light

Secondary Outcome Measures

Name	Time	Method
Correlation of the MGMT promoter methylation to the activity of the temozolomide irinotecan combination	at month 2, 4, 6, 8, 10 and 12	Correlation with level of MGMT methylation with tumor response

Trial Locations

Locations (5)

Fondazione IRCCS - Istituto Nazionale dei Tumori; 🇮🇹 Milan, Mi, Italy

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS; 🇮🇹 Candiolo, Turin, Italy

Orthopedic Rizzoli Institute; 🇮🇹 Bologna, Italy

Ospedale infantile Regina Margherita; 🇮🇹 Turin, Italy

The Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom