HD15 for advanced stage Hodgkin's disease: Quality assurance protocol for reduction of toxicity and the prognostic relevance of fluorodeoxyglucose-positron-emission tomography (FDG-PET) in the first-line treatment of advanced stage Hodgkin's disease

Completed

• Conditions: Hodgkin's disease; Cancer

• Registration Number: ISRCTN32443041
• Lead Sponsor: German Hodgkin's Lymphoma Study Group (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Chemotherapy:
1. Histologically confirmed Hodgkin's disease
2. Stage IIB and massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter) and/or extranodal involvement, stage III, and stage IV
3. No prior therapy for Hodgkin's disease
4. Age: 18 - 60 years
5. No major organ dysfunction
6. Life expectancy greater than 3 months
7. Written informed consent

PET:
1. Chemotherapy according to the HD15-protocol
2. Response to chemotherapy
3. Partial response with residual disease of at least 2.5 cm maximum diameter

Exclusion Criteria

Chemotherapy:
1. Incomplete staging
2. Major organ dysfunction:
2.1. Chronic obstructive pulmonary disease (COPD) with respiratory insufficiency
2.2. Symptomatic coronary heart disease (CHD)
2.3. Cardiomyopathy or heart failure (ejection fraction less than 50%)
2.4. Severe hypertension
2.5. Non-treatable infections
2.6. White blood count less than 3000/mm^3 or platelets less than 100,000/mm^3 if not related to bone marrow involvement
2.7. Creatinine clearance less than 60 ml/min
2.8. Bilirubin greater than 2 mg/dl if not related to Hodgkin's disease
2.9. Glutamic oxaloacetic transaminase (GOT)/aspartate aminotransferase (AST) greater than 100 U/l if not related to Hodgkin's disease
2.10. Glutamic pyruvic transaminase (GPT)/alanine aminotransferase (ALT) greater than 100 U/l if not related to Hodgkin's disease
2.11. Human immunodeficiency virus (HIV)-infection
3. Composite lymphoma
4. Prior chemotherapy or radiotherapy
5. Any history of another malignancy in the last 5 years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1)
6. Pregnancy or breastfeeding
7. World Health Organisation (WHO) performance status greater than 2
8. Long term use of corticosteroids (e.g. for arthritis) or antineoplastic substances (e.g. methotrexate)
9. Expected non-compliance
10. Current therapy for epilepsy
11. Intolerabilities against study drugs

PET:
1. Diabetes mellitus
2. Elevated blood glucose (greater than 130 mg/dl)
3. Massive bone involvement (endangering stability)

Study & Design

• Study Type: Interventional
• Study Design: Not specified