Phase 2
N=76
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Lymphoma, Hodgkin Disease · Lymphoma · Hodgkin Disease · Lymphoma: Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT00026208 ↗Enrolled (actual)
76
Serious AEs
35.5%
Results posted
May 2018
Primary outcome: Primary: Progression-free Survival (PFS) — 89.7; 50 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vincristine (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Prednisone (Drug); Bleomycin (Drug); Etoposide (Drug); Low-dose radiotherapy (RT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
89.7; 50 | — |
| SECONDARY Frequency of Complete Response |
31 | — |
| SECONDARY Early Treatment-related Toxicity |
422; 24 | — |
| SECONDARY Late Treatment-related Toxicity |
2; 0; 19; 0 | — |
| SECONDARY Second Hodgkin's Disease Progression |
3; 1 | — |
| SECONDARY Overall Survival (OS) |
10.4; 13.2 | — |
| SECONDARY Survival at 5 and 10 Years |
67; 3; 41; 3 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00026208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.