A Phase 2 interventional study of Intensity Modulated Radiation Therapy (IMRT) in Abdominal Neuroblastoma, sponsored by St. Jude Children's Research Hospital. Terminated at 1 site in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2016-03-03.
Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment
High risk neuroblastoma (NB) is an aggressive, prevalent non-brain cancer derived from nerve cells of the body. It mostly affects infants, and more children die from this tumor each year than are cured. Standard therapy includes a combination of chemotherapy, surgery, bone marrow transplant, radiation and immunotherapy. NB is very sensitive to radiation, but due to it's aggressive spread pattern, radiation use is currently limited by toxicity. This study seeks to improve delivery of radiation to reduce toxicity by quantifying outcomes, and measuring differences in renal toxicity and organ motion so that radiation can be focused more effectively against tumor while sparing normal tissues and reducing side-effects.
Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen will be eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients will begin the planning process for abdominal irradiation; this requires multiple baseline studies, including computed tomography (CT), magnetic resonance imaging (MRI), renal scintigraphy, and bloodwork. Most of these tests will be repeated on a varying schedule over the five year follow-up period of the protocol, in order to evaluate the impact of conformal radiotherapy on intra-abdominal tissues.
Intensity modulated radiation therapy (IMRT) delivery will follow current conventional volume-targeting guidelines, however, appropriate application within the abdomen will be determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease is required. Concurrent neuro-hormonal tests, cytokine analyses, functional and morphologic imaging will generate novel data describing the acute and chronic effects of radiotherapy within the abdomen.
NOTE: This study is currently closed to accrual, however, it is expected to re-open to accrual later in 2015.
625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
This study's enrollment of 14 is below the median of 32 across 475 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Risk Strata Eligibility: Patients between 6 months and 18 years of age with newly diagnosed abdominal primary, high-risk neuroblastoma defined as one of the following:
Exceptional Cases Still Considered Eligible:
Exclusion Criteria
Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen will be eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients will begin the planning process for abdominal irradiation. Interventions: Intensity Modulated Radiation Therapy (IMRT)
Radiation: Intensity Modulated Radiation Therapy (IMRT)
IMRT delivery will follow current conventional volume-targeting guidelines, however, appropriate application within the abdomen will be determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease is required. Concurrent neuro-hormonal tests, cytokine analyses, functional and morphologic imaging will generate novel data describing the acute and chronic effects of radiotherapy within the abdomen.
Also known as: IMRT
Percentage of Participants Who Failed to Reach Local-regional Control
Measured from start of radiation therapy to date of local-regional failure or last follow-up.
Time frame: 2 years after last patient enrollment
Pattern of Local-regional Failure.
Categorical measurements of local-regional failure.
Time frame: 2 years after last patient enrollment
Quantify the Range of Organ Movement During the Breathing Phase Measured by 4-dimensional MRI (4DMRI) and 4DCT.
Normal tissue motion-defining measurements were obtained which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue. Participants underwent CT simulation and 4D-CT acquisition as well as real-time dynamic 4D MRI prior to the start of radiation therapy (RT), and a subsequent repeat 4D-CT was obtained approximately 2 weeks after the start of RT. The imaging position was supine with general anesthesia. Renal edges were marked in a customized graphical interface for each imaging series with the image resolution determining the minimum motion extent. Vectors of renal edge motion were quantified in the anterior-posterior (A-P), medial-lateral (M-L), and superior-inferior (S-I) dimensions. The motion extent derived from the MRI dataset was considered in defining the margins for RT treatment planning.
Time frame: Baseline and approximately 2 weeks following initiation of irradiation.
Quantify (in mm/cm) the Range of Target Movement During the Breathing Phase Measured by 4DMRI and 4DCT.
Obtain target tissue motion-defining data which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue.
Time frame: Baseline and approximately 2 weeks following initiation of irradiation.
Fourteen participants were enrolled on the study between September 2011 and July 2013.
| Milestone | Treatment |
|---|---|
| Started | 14 |
| Completed | 4 |
| Not completed | 10 |
| Withdrew: Death | 3 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Physician decision | 3 |
Measured from start of radiation therapy to date of local-regional failure or last follow-up.
| percentage of participants | Treatment |
|---|---|
| Percentage of Participants Who Failed to Reach Local-regional Control | 0 |
Categorical measurements of local-regional failure.
No measurements were reported for this outcome.
Normal tissue motion-defining measurements were obtained which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue. Participants underwent CT simulation and 4D-CT acquisition as well as real-time dynamic 4D MRI prior to the start of radiation therapy (RT), and a subsequent repeat 4D-CT was obtained approximately 2 weeks after the start of RT. The imaging position was supine with general anesthesia. Renal edges were marked in a customized graphical interface for each imaging series with the image resolution determining the minimum motion extent. Vectors of renal edge motion were quantified in the anterior-posterior (A-P), medial-lateral (M-L), and superior-inferior (S-I) dimensions. The motion extent derived from the MRI dataset was considered in defining the margins for RT treatment planning.
| mm | Right Kidney: M-L | Right Kidney: A-P | Right Kidney: S-I | Left Kidney: M-L | Left Kidney: A-P | Left Kidney: S-I |
|---|---|---|---|---|---|---|
| Baseline 4D CT | 0.3 ± 0.4 | 0.5 ± 0.5 | 2.6 ± 1.5 | 0.5 ± 0.5 | 0.4 ± 0.4 | 2.2 ± 1.8 |
| Week 2 4D CT | 0.4 ± 0.3 | 0.4 ± 0.4 | 2.8 ± 0.8 | 0.5 ± 0.3 | 0.5 ± 0.2 | 2.3 ± 1.3 |
| Baseline MRI | 0.8 ± 1.0 | 0.5 ± 0.7 | 2.6 ± 0.8 | 0.5 ± 0.7 | 0.3 ± 0.6 | 2.3 ± 0.8 |
Obtain target tissue motion-defining data which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue.
No measurements were reported for this outcome.
Collected over Adverse events were collected from the initiation of radiation therapy until completion of study, removal from study, or disease recurrence, up to 2 years after the last participant enrollment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 2/14 (14.3%) | 9/14 (64.3%) |
| Event | Treatment |
|---|---|
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 1/14 |
| Intraoperative hemorrhageInjury, poisoning and procedural complications | 1/14 |
| Event | Treatment |
|---|---|
| Lymphocyte count decreasedBlood and lymphatic system disorders | 8/14 |
| Platelet count decreasedBlood and lymphatic system disorders | 5/14 |
| White blood cell decreasedBlood and lymphatic system disorders | 2/14 |
| Neutrophil count decreasedBlood and lymphatic system disorders | 1/14 |
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 4.9 ± 3.1 |
| Age, Continuous(years) | Treatment |
|---|---|
| Median | 4.1 (0.9 to 10.9) |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 11 |
| Male | 3 |
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