Clinical trial NCT00026208: Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Official title: Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Hodgkin Disease
Lymphoma
Hodgkin Disease
Lymphoma: Hodgkin
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Frequency of Complete Response
timeFrame: 5 weeks
measure: Early Treatment-related Toxicity
timeFrame: Within 30 days of treatment
measure: Late Treatment-related Toxicity
timeFrame: 16 years
measure: Second Hodgkin's Disease Progression
timeFrame: 16 years
measure: Overall Survival (OS)
timeFrame: 16 years
measure: Survival at 5 and 10 Years
timeFrame: 5 and 10 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Ranjana H Advani, MD
role: PRINCIPAL_INVESTIGATOR
References: