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Sponsored by: |
Cancer Research UK |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00678327 |
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: bleomycin sulfate Biological: filgrastim Biological: pegfilgrastim Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma |
Estimated Enrollment: | 1200 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Active Comparator
Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Biological: bleomycin sulfate
Given IV
Drug: dacarbazine
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vinblastine
Given IV
|
Arm II: Active Comparator
Patients receive AVD chemotherapy comprising doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: dacarbazine
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vinblastine
Given IV
|
BEACOPP-14 chemotherapy: Experimental
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Biological: bleomycin sulfate
Given IV
Biological: filgrastim
Given subcutaneously
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: prednisolone
Given orally
Drug: procarbazine hydrochloride
Given orally
Drug: vincristine sulfate
Given IV
|
BEACOPP-escalated chemotherapy: Experimental
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
Biological: bleomycin sulfate
Given IV
Biological: filgrastim
Given subcutaneously
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: prednisolone
Given orally
Drug: procarbazine hydrochloride
Given orally
Drug: vincristine sulfate
Given IV
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin lymphoma (HL) meeting the following criteria:
Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with adverse features, including any of the following:
PATIENT CHARACTERISTICS:
No known positivity for HIV, hepatitis B surface antigen, or hepatitis C
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Peter Johnson, MD 44-2380-796-186 johnsonp@soton.ac.uk |
Principal Investigator: | Peter Johnson, MD | Southampton General Hospital |
Study ID Numbers: | CDR0000593562, CRUK-2007-006064-30, CRUK-07/146 |
Study First Received: | May 9, 2008 |
Last Updated: | June 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00678327 History of Changes |
Health Authority: | Unspecified |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma |
adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma stage II adult Hodgkin lymphoma |
Anti-Inflammatory Agents Dacarbazine Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Vinblastine Prednisolone acetate Cyclophosphamide Hormones Etoposide phosphate Anti-Bacterial Agents Alkylating Agents Hodgkin Disease Lymphoma |
Etoposide Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hodgkin Lymphoma, Adult Methylprednisolone acetate Hodgkin's Disease Vincristine Sclerosis Antimitotic Agents Glucocorticoids Bleomycin Immunosuppressive Agents Doxorubicin Lymphatic Diseases |
Anti-Inflammatory Agents Dacarbazine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Vinblastine Cyclophosphamide Antibiotics, Antineoplastic Hormones Therapeutic Uses Alkylating Agents Lymphoma Hodgkin Disease |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Bleomycin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators |