Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00433459 |
Recruitment Status :
Completed
First Posted : February 12, 2007
Last Update Posted : March 26, 2020
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: cyclophosphamide Drug: dacarbazine Drug: prednisolone Drug: prednisone Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: fludeoxyglucose F 18 Radiation: radiation therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2134 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: COPP
procarbazine-containing consolidation chemotherapy arm
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Drug: cyclophosphamide
drug is used in first line treatment in combination (COPP or COPDAC)
Other Name: CYC Drug: prednisolone drug is used in first line treatment in combination (OEPA, COPP or COPDAC) Drug: prednisone drug is used in first line treatment in combination (OEPA, COPP or COPDAC) Drug: procarbazine hydrochloride drug is used in first line treatment in combination (COPP) Drug: vincristine sulfate drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Other Name: VCR Radiation: fludeoxyglucose F 18 used as a diagnostic marker for metabolically active tumour at staging and response assessment Radiation: radiation therapy part of combination treatment (combined modality between chemo- and radiotherapy)
Other Name: IFRT |
Experimental: COPDAC
procarbazine-free consolidation chemotherapy arm
|
Drug: cyclophosphamide
drug is used in first line treatment in combination (COPP or COPDAC)
Other Name: CYC Drug: dacarbazine drug is used in first line treatment in combination (COPDAC)
Other Name: DTIC Drug: prednisolone drug is used in first line treatment in combination (OEPA, COPP or COPDAC) Drug: prednisone drug is used in first line treatment in combination (OEPA, COPP or COPDAC) Drug: vincristine sulfate drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Other Name: VCR Radiation: fludeoxyglucose F 18 used as a diagnostic marker for metabolically active tumour at staging and response assessment Radiation: radiation therapy part of combination treatment (combined modality between chemo- and radiotherapy)
Other Name: IFRT |
- Event-free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Progression-free survival [ Time Frame: 5 years ]
- CTC (Common toxicity criteria) toxicity levels of therapy elements [ Time Frame: 5 years ]
- Evidence of male infertility score [ Time Frame: 5 years ]
- Evidence of female infertility score [ Time Frame: 5 years ]
- Long-term consequences (e.g., premature menopause, secondary cancer) [ Time Frame: 5 years ]
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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed classical Hodgkin's lymphoma
- No lymphocyte-predominant Hodgkin's lymphoma
- Fine-needle biopsy not sufficient
- No prior treatment for Hodgkin's lymphoma except for recommended pre-phase therapy for a large mediastinal tumor
PATIENT CHARACTERISTICS:
- No known hypersensitivity or contraindication to study drugs
- No other current malignancy
- No severe concurrent disease (e.g., immune deficiency syndrome)
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for up to 1 year after completion of study treatment
- No known HIV positivity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy
- At least 30 days since prior and no other concurrent investigational drugs or participation in another investigational trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433459
Germany | |
Universitaetsklinikum Giessen-Marburg | |
Giessen, Germany, D-35385 | |
United Kingdom | |
Royal Hospital for Sick Children | |
Edinburgh, Scotland, United Kingdom, EH9 1LF |
Study Chair: | Dieter Koerholz, MD | Martin-Luther-Universität Halle-Wittenberg | |
Principal Investigator: | W. Hamish Wallace, MD | Royal Hospital for Sick Children | |
Principal Investigator: | Judith Landman-Parker, MD | Hopital d'Enfants Trousseau |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Christine Mauz-Körholz, Prof. Dr. med. Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg |
ClinicalTrials.gov Identifier: | NCT00433459 |
Other Study ID Numbers: |
CDR0000531687 EURONET-PHL-C1 EU-20703 EUDRACT-2006-000995-33 CCLG-HD-2007-10 |
First Posted: | February 12, 2007 Key Record Dates |
Last Update Posted: | March 26, 2020 |
Last Verified: | March 2020 |
childhood lymphocyte depletion Hodgkin lymphoma childhood mixed cellularity Hodgkin lymphoma childhood nodular sclerosis Hodgkin lymphoma stage I childhood Hodgkin lymphoma |
stage II childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma |
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Prednisolone Cyclophosphamide Dacarbazine Vincristine Procarbazine Fluorodeoxyglucose F18 |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents, Phytogenic |