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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
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):
Ranjana Advani, Stanford University

November 9, 2001
January 27, 2003
March 6, 2017
June 2001
February 13, 2017   (Final data collection date for primary outcome measure)
Progression-free survival by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]
Not Provided
Complete list of historical versions of study NCT00026208 on ClinicalTrials.gov Archive Site
  • Early and late treatment-related toxicity [ Time Frame: Duration of study ]
  • Freedom from second disease progression by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]
  • Overall survival by Kaplan-Meier [ Time Frame: at 5 and 10 years ]
  • Frequency of complete response by positron-emission tomography scan [ Time Frame: between weeks 4 and 5 of chemotherapy ]
Not Provided
Not Provided
Not Provided
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study

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 II 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.


  • 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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lymphoma, Hodgkin Disease
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma: Hodgkin
  • Drug: bleomycin
    5 u/m2 IV week 2, 4, 6, 8
  • Drug: cyclophosphamide
    650 mg/m2
  • Drug: prednisone
    40 mg/m2, Oral. Every other day. Taper 10 mg qod during last 2 weeks of chemotherapy
  • Drug: vincristine
    1.4 mg/m2; IV wk 2, 4, 6, 8
  • Drug: Adriamycin
    25 mg/m2
  • Drug: Velban
    6 mg/m2, IV wk 1, 3, 5, 7
  • Drug: VP-16
    60 mg/m2 x 2; IV wk 3, 7 (d 15, 16, 43, 44)
Experimental: chemotherapy + Stanford V-C
  • Drug: bleomycin
  • Drug: cyclophosphamide
  • Drug: prednisone
  • Drug: vincristine
  • Drug: Adriamycin
  • Drug: Velban
  • Drug: VP-16
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 13, 2017
February 13, 2017   (Final data collection date for primary outcome measure)


  • 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



  • 18 to 70

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Granulocyte count at least 2,000/mm^3
  • Platelet count at least 150,000/mm^3


  • Bilirubin no greater than 2.5 mg/dL


  • Creatinine no greater than 2 mg/dL


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


  • 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


Biologic therapy:

  • No prior biologic therapy


  • No prior chemotherapy

Endocrine therapy:

  • No prior endocrine therapy


  • No prior radiotherapy


  • Not specified


  • No other concurrent investigational drugs
  • No other concurrent antineoplastic therapy
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
IRB-13081 ( Other Identifier: Stanford IRB )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Ranjana Advani, Stanford University
Stanford University
Not Provided
Principal Investigator: Ranjana Advani Stanford University
Stanford University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP