NCT00352027已完成2 期
Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- 3-year Event-Free Survival Probability
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is less than or equal to 21 years of age
- •Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
- •Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.
排除标准
- •Patients with favorable risk features
- •Patients with unfavorable risk features
- •Patients who have received prior therapy for Hodgkin lymphoma.
研究组 & 干预措施
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: G-CSF (Biological)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Radiotherapy (Procedure)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Adriamycin® (Drug)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Vinblastine (Drug)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Nitrogen Mustard (Drug)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Cyclophosphamide (Drug)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Vincristine (Drug)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Bleomycin (Drug)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Etoposide (Drug)
All Participants
Experimental
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
干预措施: Prednisone (Drug)
结局指标
主要结局
3-year Event-Free Survival Probability
时间窗: 3 years
The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.
次要结局
- Patient Quality of Life (QoL), PedsQL v.4.0: Total Score(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 Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning(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 Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt(At 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 Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning(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)
- Local and Distant Failure for Children Treated With Tailored-field Radiation(from first enrollment date up to 3 years follow-up)
- Patient Quality of Life (QoL), PedsQL v.3.0: Worry(At 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 Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health(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 Quality of Life (QoL), PedsQL v.4.0: School Functioning(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 Quality of Life (QoL), PedsQL v.3.0: Total Score(At 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 Quality of Life (QoL), PedsQL v.3.0: Communication(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score(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)
- Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning(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)
- Disease Failure Rate Within Radiation Fields(3 years)
- Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning(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 Quality of Life (QoL), PedsQL v.4.0:Social Functioning(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 Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance(At 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)
- Prognostic Factors for Treatment Failure: Age(5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up)
- Patient Quality of Life (QoL), PedsQL v.3.0: Nausea(At 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 Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety(At 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 Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication(At 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 Quality of Life (QoL), Symptom Distress Scale(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)
- Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning(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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning(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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health(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)
- Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning(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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance(At 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)
- Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning(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)
- Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health(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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication(At 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)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score(6 months after the completion of therapy)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score(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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning(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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea(At 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)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety(6 months after the completion of therapy)
- 3-year Event-free Survival (EFS) Probability(3 years)
- Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)(1, 2, 5, and 10 years post therapy)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning(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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt(At 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)
- Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety(At 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)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance(6 months after the completion of therapy)
- 3-year Local Failure-free Survival Probability(3 years)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry(6 months after the completion of therapy)
- 3-year Overall Survival (OS) Probability(3-years)
- Toxicities With Grade >1(3 years)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems(6 months after the completion of therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication(6 months after the completion of therapy)
- Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)(1, 2, 5, and 10 years post therapy)
- Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt(6 months after the completion of therapy)
- Prognostic Factors for Treatment Failure: Gender(3 years follow-up)
- Prognostic Factors for Treatment Failure: Histology(3 years follow-up)
- Prognostic Factors for Treatment Failure: Stage(5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up)
- Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)(1, 2, 5, and 10 years post therapy)
- Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)(1, 2, 5, and 10 years post therapy)
研究者
研究点 (6)
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