HD 18 for advanced stages: treatment optimization trial in the first line treatment of advanced stage Hodgkin Lymphoma; treatment stratification by means of FDG-PET.

Phase 3

Completed

Conditions: malignant lymphoma
Hodgkin's disease
10025319

Registration Number: NL-OMON46958

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1.Histologically proven primary diagnosis of Hodgkin lymphoma;
2. Stage:
2.1 CS (PS) IIB with one or both of the following risk factors:
a) Large mediastinal mass (><= 1/3 of the maximum transverse diameter of the
thorax),
b) Extranodal lesions (see definition in section 14.3.4);
2.2 CS (PS) III, IV;
3. Patient had no previous treatment for HL;
4. Age at entry: 18 - 60 years;
5. 6. Normal organ function (except HL-related);
6. Negative HIV test
7. In women: negative pregnancy test
8. Life expectancy > 3 months.

Exclusion Criteria

1. Incomplete diagnosis of the disease stage;
2. Prior or concurrent disease that prevents treatment according to protocol;
3. HL as composite lymphoma;
4. Prior chemotherapy or radiation;
5. Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in
situ of the cervix uteri, completely resected melanoma TNMpT1);
6. Pregnancy, lactation;
7. WHO activity index > 2;
8. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or
antineoplastic drugs (e.g. methotrexate)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progresion Free Survival (PFS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Overall survival<br /><br>Acute and late toxicity of treatment<br /><br>Quality of Life<br /><br>Secondary maligancy rate<br /><br>CR rate<br /><br>HL-specific death rate<br /><br>Prognostic value of the PET-2 examination</p><br>