Clinical Trial: Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma
Brief Summary: The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.
Detailed Summary:
Treatment Plan Description:
Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9
Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)
Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11
Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12
G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.
Sponsor: St. Jude Children's Research Hospital
Current Primary Outcome: 3-year Event-Free Survival Probability [ Time Frame: 3 years ]
Original Primary Outcome: To determine the event free survival for patients treated with reduced chemotherapy and radiation
Current Secondary Outcome:
- Disease Failure Rate Within Radiation Fields [ Time Frame: 3 years ]Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
- Local and Distant Failure for Children Treated With Tailored-field Radiation [ Time Frame: from first enrollment date up to 3 years follow-up ]The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.
- Prognostic Factors for Treatment Failure: Age [ Time Frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up ]Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.
- Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy [ Time Frame: 1, 2, 5, and 10 years post therapy ]
- Patient Quality of Life (QoL), PedsQL v.4.0: Total Score [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
- Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
- Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
- Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
- Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
- Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ]
Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
- Patient Quality of Life (QoL), PedsQL v.3.0: Total Score [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of
Original Secondary Outcome: To study the quality of life for these patients before during and after treatment
Information By: St. Jude Children's Research Hospital
Dates:
Date Received: July 13, 2006
Date Started: July 2006
Date Completion: November 2022
Last Updated: September 19, 2016
Last Verified: September 2016
