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

• Conditions: 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-BE
• Lead Sponsor: Euopean Organisation of Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-15
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

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

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), see at the end of this section)
- Previously untreated
- Age 15 through 70 years
- FDG-PET scan highly recommended at baseline and already prospectively planned after two cycles of ABVD for all patients (see Appendix I)
- WHO performance status grades 0, 1, 2 or 3 (see Appendix B) during the whole duration of study treatment.
- Absence of severe cardiac, pulmonary, neurologic psychiatric or metabolic disease. Patients with unstable diabetes mellitus are excluded (to avoid uninterpretable FDG-PET scan).
- Adequate liver and renal function (total serum bilirubin = 2.5 x ULN, serum creatinine = 2.5 x ULN)
- No concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for >5 years
- No known HIV infection
- Written informed consent or confirmed informed consent according to ICH/EU Good Clinical Practice, and national/local regulations. Parent's consent is required for patients 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

Pregnant or breast-feeding women

Study & Design

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