Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT02615106|
Recruitment Status : Unknown
Verified June 2016 by Chuanying Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : November 25, 2015
Last Update Posted : June 14, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Endostar Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2018|
Experimental: Endostar Combined With Radiotherapy
Drug: Endostar Endostar 7.5 mg/m2/day, day 1-14 Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
7.5 mg/m2/day, day 1-14
Other Name: recombinant human endostatin
Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: first analysis will occur 1 month after accrual of all patients ]
- Progression free survival(PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
- Overall survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
- Objective response rate (ORR) [ Time Frame: first analysis will occur 1 month after accrual of all patients ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites.
- Life expectancy of greater than 12 months.
- ECOG performance status ≤2
- Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.
- Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.
- Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.
- Patients will be ineligible if any prior therapeutic radiation therapy > 500 cGy has been delivered.
- Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.
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 ClinicalTrials.gov identifier (NCT number): NCT02615106
|Contact: chuanying zhu, MDemail@example.com|
|The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200092|
|Contact: Chuanying zhu, MD 862125076994 firstname.lastname@example.org|
|Principal Investigator: Mawei Jiang, MD|
|Principal Investigator:||mawei jiang, MD||The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine|
|Responsible Party:||Chuanying Zhu, doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|
|Other Study ID Numbers:||
|First Posted:||November 25, 2015 Key Record Dates|
|Last Update Posted:||June 14, 2016|
|Last Verified:||June 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Angiogenesis Modulating Agents
Physiological Effects of Drugs