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Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma, Hodgkin Disease, Lymphoma, Hodgkin Disease, Lymphoma: Hodgkin

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Trial Information

Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study


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.

- 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 radiotherapy 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.

OUTLINE: This is a multicenter study.

Patients receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30-60 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 1-8; 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. Beginning 2-3 weeks after completion of
chemotherapy, patients undergo low-dose radiotherapy 5 days a week for approximately 3
weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 5 years.


Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of stage I or IIA Hodgkin's lymphoma

- Previously untreated disease

- Eligible subtypes:

1. Nodular sclerosis

2. Mixed cellularity

3. Classical, not otherwise specified

- No lymphocyte-predominant Hodgkin's lymphoma

- No mediastinal mass that is one-third or more of the maximum intrathoracic diameter
on a standing posterior chest x-ray

- No lymph node mass more than 10 cm in greatest transaxial diameter

- No more than 1 extranodal site of disease

- No constitutional (B) symptoms present at diagnosis

PATIENT CHARACTERISTICS:

Age:

- 18 to 70

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 2,000/mm^3

- Platelet count at least 150,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

Renal:

- Creatinine no greater than 2 mg/dL

Cardiovascular:

- Ejection fraction at least 50% for patients over age 50 or with a history of cardiac
disease

Other:

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior or concurrent malignancy within the past 5 years except basal cell
skin cancer

- No other medical contraindication to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- No prior endocrine therapy

Radiotherapy:

- No prior radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational drugs

- No other concurrent antineoplastic therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival by Kaplan-Meier

Outcome Time Frame:

at completion of therapy and then annually for 3 years

Safety Issue:

No

Principal Investigator

Louis Fehrenbacher

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kaiser Permanente Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

LYMHD0002

NCT ID:

NCT00026208

Start Date:

June 2001

Completion Date:

May 2015

Related Keywords:

  • Lymphoma, Hodgkin Disease
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma: Hodgkin
  • Hodgkin Disease
  • Lymphoma

Name

Location

Stanford University School of MedicineStanford, California  94305-5317
Kaiser Permanente Medical CenterVallejo, California  94589