The H10 EORTC/GELA randomized Intergroup trial on early FDGPET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin,s lymphoma

• Conditions: Patients with supradiaphragmatic stage I/II Hodgkin`s lymphoma; MedDRA version: 14.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-002765-37-IT
• Lead Sponsor: EORTC Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-12
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1797

Inclusion Criteria

- Histologically confirmed Hodgkin`s lymphoma (HL), except for nodular lymphocyte predominant subtype (nodular paragranuloma); -Supradiaphragmatic Ann Arbor clinical stage I or II; -Previously untreated; - Clinical stages I/II; - Age 18-70 years; - WHO performance 0-3: - FDG-PET scan prospectively planned after two cycles of ABVD in all patients; - Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1774
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Histologically not confirmed Hodgkin's lymphoma (HL), - lymphocyte predominant subtype (nodular paragranuloma:) - Previously treated; - Age <18 or >70 years - WHO performance >3 - Pregnat or breast-feeding women - HIV infection - Absence of Informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified