HD13 for early stage Hodgkin's disease: quality assurance protocol for reduction of toxicity in the first-line treatment of early stage Hodgkin's Disease (HD)

Not Applicable

Completed

• Conditions: Hodgkin's disease; Cancer

• Registration Number: ISRCTN63474366
• Lead Sponsor: German Hodgkin's Lymphoma Study Group (Germany)

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25539730 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26834240 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29989855

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-10-29
• Study Completion: 2008-01-01
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

1. Histologically confirmed Hodgkin's disease
2. Stages IA (not lympocyte predominant HD), IB, IIA, and IIB without the following risk factors:
2.1. Massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter
2.2. Extranodal involvement
2.3. High Erythrocyte Sedimentation Rate (ESR) (greater than or equal to 50 mm; greater than or equal to 30 mm with B symptoms)
2.4. Three or more involved lymph node areas
3. No prior therapy for Hodgkin's disease
4. Aged 18 - 75 years
5. No major organ dysfunction
6. Life expectancy more than three months
7. Written informed consent

Exclusion Criteria

1. Incomplete staging
2. Major organ dysfunction (Chronic Obstructive Pulmonary Disease [COPD] with respiratory insufficiency, symptomatic Coronary Heart Disease [CHD], cardiomyopathy or heart failure [ejection fraction less than 50%], severe hypertension, non-treatable infections, white blood count less than 3000/mm^3 or platelets less than 100,000/mm^3, creatinine clearance less than 60 ml/min, bilirubin more than 2 mg/dl, Glutamic-Oxaloacetic Transaminase [GOT]/aspartate aminotransferase [AST] more than 100 U/l, Glutamic-Pyruvic Transaminase [GPT]/alanine aminotransferase [ALT] more than 100 U/l, Human Immunodeficiency Virus [HIV]-infection)
3. Composite lymphoma
4. Prior chemotherapy or radiotherapy
5. Any history of another malignancy in the last five years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1)
6. Pregnancy or breastfeeding
7. World Health Organization (WHO) performance status more than two
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
12. Inability to give truly informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified