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. 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

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 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.

Condition or disease Intervention/treatment Phase
Lymphoma, Hodgkin Disease Lymphoma Hodgkin Disease Lymphoma: Hodgkin Drug: bleomycin Drug: cyclophosphamide Drug: prednisone Drug: vincristine Drug: Adriamycin Drug: Velban Drug: VP-16 Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
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 : February 13, 2017
Actual Study Completion Date : February 13, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: chemotherapy + Stanford V-C 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)

Primary Outcome Measures :
  1. Progression-free survival by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]

Secondary Outcome Measures :
  1. Early and late treatment-related toxicity [ Time Frame: Duration of study ]
  2. Freedom from second disease progression by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]
  3. Overall survival by Kaplan-Meier [ Time Frame: at 5 and 10 years ]
  4. Frequency of complete response by positron-emission tomography scan [ Time Frame: between weeks 4 and 5 of chemotherapy ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

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 identifier (NCT number): NCT00026208

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
Principal Investigator: Ranjana Advani Stanford University

Responsible Party: Ranjana Advani, Saul A. Rosenberg, MD, Professor of Lymphoma, Stanford University Identifier: NCT00026208     History of Changes
Other Study ID Numbers: LYMHD0002
IRB-13081 ( Other Identifier: Stanford IRB )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents