Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00026208 |
|
Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : May 15, 2018
Last Update Posted : July 24, 2018
|
Sponsor:
Stanford University
Information provided by (Responsible Party):
Ranjana Advani, Stanford University
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Hodgkin Disease Lymphoma Hodgkin Disease Lymphoma: Hodgkin | Drug: Vincristine Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Bleomycin Drug: Etoposide Radiation: Low-dose radiotherapy (RT) | Phase 2 |
OBJECTIVES:
- 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 76 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients with tumors 5 to 10 cm were to be assigned to concurrent radiotherapy, and participants with tumors less than 5 cm were initially planned to not receive radiotherapy. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study |
| Study Start Date : | June 2001 |
| Actual Primary Completion Date : | April 26, 2013 |
| Actual Study Completion Date : | February 13, 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide. Radiotherapy = 20 Gy modified involved field radiotherapy |
Drug: Vincristine
1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
Other Names:
Drug: Cyclophosphamide 650 mg/m², on week 1 and 5
Other Names:
Drug: Doxorubicin 25 mg/m², on week 1, 3, 5, 7
Other Names:
Drug: Prednisone 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
Other Names:
Drug: Bleomycin 5 u/m² intravenously (IV) on week 2, 4, 6, 8
Other Names:
Drug: Etoposide 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Other Names:
Radiation: 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. |
|
Experimental: Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
|
Drug: Vincristine
1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
Other Names:
Drug: Cyclophosphamide 650 mg/m², on week 1 and 5
Other Names:
Drug: Doxorubicin 25 mg/m², on week 1, 3, 5, 7
Other Names:
Drug: Prednisone 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
Other Names:
Drug: Bleomycin 5 u/m² intravenously (IV) on week 2, 4, 6, 8
Other Names:
Drug: Etoposide 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Other Names:
|
Primary Outcome Measures :
- Progression-free Survival (PFS) [ Time Frame: up to 3 years ]Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.
Secondary Outcome Measures :
- Frequency of Complete Response [ Time Frame: 5 weeks ]The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as "complete regression of all palpable and radiographic demonstrable disease" by computed tomography (CT) scan or positron emission tomography-CT (PET-CT).
- Early Treatment-related Toxicity [ Time Frame: Within 30 days of treatment ]Early treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment.
- Late Treatment-related Toxicity [ Time Frame: 16 years ]Late treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis.
- Second Hodgkin's Disease Progression [ Time Frame: 16 years ]Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis.
- Overall Survival (OS) [ Time Frame: 16 years ]Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.
- Survival at 5 and 10 Years [ Time Frame: 5 and 10 years ]Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
-
Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes
- 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:
- Lymphocytic predominance Hodgkin's disease
- 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)
Information from the National Library of Medicine
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): NCT00026208
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Kaiser Permanente Medical Center | |
| Vallejo, California, United States, 94589 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Ranjana H Advani, MD | Stanford University |
| Responsible Party: | Ranjana Advani, Saul A. Rosenberg, MD, Professor of Lymphoma, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00026208 |
| Other Study ID Numbers: |
IRB-13081 LYMHD0002 ( Other Identifier: OnCore ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | May 15, 2018 |
| Last Update Posted: | July 24, 2018 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
|
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Cyclophosphamide Doxorubicin Liposomal doxorubicin Etoposide Etoposide phosphate Vincristine |
Bleomycin Vinblastine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |