The H10 EORTC/GELA randomized intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma - H10

Phase 1

• Conditions: Stages I/II Hodgkin's lymphoma; MedDRA version: 8.1Level: PTClassification code 10020328Term: Hodgkin's lymphoma

• Registration Number: EUCTR2005-002765-37-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-29
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1576

Inclusion Criteria

- Histologically proven Hodgkin's lymphoma, except for the nodular lymphocyte predominant subtype (nodular paragranuloma).
- Supradiaphragmatic Ann Arbor clinical stage I or II, both favorable and unfavorable prognostic subsets (for definition of favorable (F )and unfavorable (U)).
- Previously untreated.
- Age 15 through 70 years.
- FDG-PET scan already prospectively planned after two cycles of ABVD for all patients.
- WHO performance status grades 0, 1, 2 or 3.
- Pregnant or breast-feeding women are excluded.
- Patients of childbearing/reproductive potential should be use adequate birth control measures during the whole duration of study treatment.
- Absence of severe cardiac, pulmonary, neurologic psychiatric or metabolic disease. Patients with unstable diabetes mellitus are exclued (to avoid uninterpretable FDG-PET scan).
- Adequate liver and renal function (total serum bilirubin < or = 2,5 x ULN, serum creatinine < or = 2,5 x ULN).
- No concomitant or previous malignancies with the exception of basal cell skin tumors, adequaly treated carcinoma in situ of the cervix and any cancer that has been in complete remission for > 5 years.
- No know HIV infection.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Written informed consent or confirmed informed consent according to ICH/EU Good Clinical Practice, and national/local regulations. Parent's consent is required for patient under 18 years of age.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

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