Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
NCT ID: NCT00026208
Last Updated: 2018-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2001-06-30
2017-02-13
Brief Summary
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PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
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Detailed Description
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* Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with "Stanford V-C" chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy (RT).
* Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of RT to moderately bulky sites of disease.
* Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.
Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were assigned to treatment on the basis of tumor size (\< 5 cm vs 5 to 10 cm), with only the participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks. Subsequent to amendment, all participants received RT.
Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
Vincristine
1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
Cyclophosphamide
650 mg/m², on week 1 and 5
Doxorubicin
25 mg/m², on week 1, 3, 5, 7
Prednisone
40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
Bleomycin
5 u/m² intravenously (IV) on week 2, 4, 6, 8
Etoposide
60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Low-dose radiotherapy (RT)
20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Vincristine
1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
Cyclophosphamide
650 mg/m², on week 1 and 5
Doxorubicin
25 mg/m², on week 1, 3, 5, 7
Prednisone
40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
Bleomycin
5 u/m² intravenously (IV) on week 2, 4, 6, 8
Etoposide
60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Interventions
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Vincristine
1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
Cyclophosphamide
650 mg/m², on week 1 and 5
Doxorubicin
25 mg/m², on week 1, 3, 5, 7
Prednisone
40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
Bleomycin
5 u/m² intravenously (IV) on week 2, 4, 6, 8
Etoposide
60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Low-dose radiotherapy (RT)
20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Nodular sclerosis
* Mixed cellularity
* Classical, not otherwise specified
* Age ≥ 18 years and ≤ 70 years
* Granulocytes ≥ 2 x 10e6/µL
* Platelets ≥ 150 x 10e6/µL
* Bilirubin ≤ 2.5 mg/dL
* Serum creatinine ≤ 2 mg/dL
* Patients \> 50 years or those with a history of cardiac disease should have an ejection fraction ≥ 50%
* All scans, X-rays, laboratory tests must be performed within 6 weeks of enrollment
* Pathologic material reviewed at Stanford University
* Evaluation by Stanford Medical Oncology and Radiation Oncology with review at the Hodgkin's Disease Staging Conference
* Written informed consent
Exclusion Criteria
* Prior treatment for Hodgkin's disease
* Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on a standing posteroanterior chest x-ray
* Any lymph node mass \> 10 cm in greatest trans-axial diameter
* Two or more extranodal sites of disease
* Constitutional (B) symptoms present at diagnosis
* Prior or concurrent malignancies within 5 years (EXCEPTION: basal cell carcinoma of the skin)
* Any medical contraindication to the planned treatment, including:
* Pregnant
* Positive antibody test for the human immunodeficiency virus (HIV)
18 Years
70 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Principal Investigators
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Ranjana H Advani, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Countries
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Other Identifiers
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LYMHD0002
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-13081
Identifier Type: -
Identifier Source: org_study_id
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