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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01222 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Lance Armstrong Foundation | OTHER |
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Researchers at St. Jude Children's Research Hospital are looking for more effective ways to deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the study is to improve local control of musculoskeletal tumors with image-guided radiation therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to precisely define tumor location and to carefully plan radiation treatment. This approach allows doctors to deliver highly conformal radiation therapy to the tumor while protecting nearby healthy normal tissues.
The study focuses on the following primary Objectives:
To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).
The study focuses on the following secondary objectives:
Establish a quantitative baseline estimate of radiation dose-related changes in normal tissues using novel objective measures of somatic change, musculoskeletal function, tissue biochemistry and physiology.
o Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations including:
Describe the severity and time course of radiation-induced changes in the soft tissues including muscle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| image-guided radiotherapy | Radiation | Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Local Failures at 5 Years in Patients With Image Guided Radiation Therapy | The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST). | 5-years follow-up after completion of therapy. |
| Cumulative Incidence of Local Failures at 10 Years in Patients With Image Guided Radiation Therapy | The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST). | 10- years follow-up after completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Growth Rate and Length of Bone, Bone Density, Development of Muscle (Muscle Function, e.g. Range of Motion), Occurrence of Organ Specific (e.g. Lung, Skin) CTC Measured Toxicities. | Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations. | Time to local failure (local control) over 5 years follow-up after completion of therapy |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Krasin, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18234441 | Background | Hua C, Gray JM, Merchant TE, Kun LE, Krasin MJ. Treatment planning and delivery of external beam radiotherapy for pediatric sarcoma: the St. Jude Children's Research Hospital experience. Int J Radiat Oncol Biol Phys. 2008 Apr 1;70(5):1598-606. doi: 10.1016/j.ijrobp.2007.12.013. Epub 2008 Jan 30. | |
| 19625137 | Background |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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A total of 202 patients were enrolled in the study. Of 202 patients, 167 patients completed the study requirements, progression, death, and secondary malignancy, 9 patients still are in follow-up, and 26 patients were off study early due to parent or patient request, PI discretion, physician's discretion, Ineligible, and not returning to St. Jude. Completed ACT trial.
202 participants were enrolled between January 10, 2003 and July, 9, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations. image-guided radiotherapy: Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated. A total of 202 patients were enrolled in the study. Of 202 patients, 167 patients completed the study requirements, progression, death, and secondary malignancy, 9 patients still are in follow-up, and 26 patients were off study early due to parent or patient request, PI discretion, physician's discretion, Ineligible, and not returning to St. Jude. Completed ACT trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations. image-guided radiotherapy: Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated. A total of 202 patients were enrolled in the study. Of 202 patients, 167 patients completed the study requirements, progression, death, and secondary malignancy, 9 patients still are in follow-up, and 26 patients were off study early due to parent or patient request, PI discretion, physician's discretion, Ineligible, and not returning to St. Jude. Completed ACT trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Incidence of Local Failures at 5 Years in Patients With Image Guided Radiation Therapy | The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST). | Of 202 patients enrolled in the study, 199 patients were treated with radiation therapy. Three patients were off study before radiation therapy. Cumulative incidence of local failure is calculated from completion of RT to dates of local failure, distant failure (metastatic), the secondary malignancy, death, or off study (last contact) while distant failure (metastatic), the secondary malignancy, and death are considered as competing risks. | Posted | Number | 95% Confidence Interval | percentage of patients | 5-years follow-up after completion of therapy. |
|
Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations. image-guided radiotherapy: Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated. A total of 202 patients were enrolled in the study. Of 202 patients, 167 patients completed the study requirements, progression, death, and secondary malignancy, 9 patients still are in follow-up, and 26 patients were off study early due to parent or patient request, PI discretion, physician's discretion, Ineligible, and not returning to St. Jude. Completed ACT trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Middle ear/hearing | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight loss | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Krasin, MD | St. Jude Children's Research Hospital | (901) 595-3226 | matthew.krasin@stjude.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2023 | Jan 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Changes in Growth Rate and Length of Bone, Bone Density, Development of Muscle (Muscle Function, e.g. Range of Motion), Occurrence of Organ Specific (e.g. Lung, Skin) CTC Measured Toxicities. | Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations. | Time to local failure (local control) over 10 years follow-up after completion of therapy |
| Muscle Function Over Time, PET, DCE-MR, T2* MR Quantitative Parameters. | Describe the severity and time course of radiation-induced changes in the soft tissues and adjacent organs, including muscle and subcutaneous tissues. | Change from baseline as well as comparison to non-treated side (when available) during the first 5 years after completion of therapy. |
| Krasin MJ, Davidoff AM, Xiong X, Wu S, Hua CH, Navid F, Rodriguez-Galindo C, Rao BN, Hoth KA, Neel MD, Merchant TE, Kun LE, Spunt SL. Preliminary results from a prospective study using limited margin radiotherapy in pediatric and young adult patients with high-grade nonrhabdomyosarcoma soft-tissue sarcoma. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):874-8. doi: 10.1016/j.ijrobp.2009.02.074. Epub 2009 Jul 20. |
| 17145403 | Background | Krasin MJ, Xiong X, Reddick WE, Ogg RJ, Hoffer FA, McCarville B, Kaste SC, Spunt SL, Navid F, Davidoff AM, Zhang L, Kun LE, Merchant TE. A model for quantitative changes in the magnetic resonance parameters of muscle in children after therapeutic irradiation. Magn Reson Imaging. 2006 Dec;24(10):1319-24. doi: 10.1016/j.mri.2006.08.004. Epub 2006 Oct 25. |
| 17097831 | Background | Hua C, Shukla HI, Merchant TE, Krasin MJ. Estimating differences in volumetric flat bone growth in pediatric patients by radiation treatment method. Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):552-8. doi: 10.1016/j.ijrobp.2006.08.069. Epub 2006 Nov 9. |
| Background | M.J. Krasin; X. Xiong; L. Zhang; W.E. Reddick; T.E. Merchant. A Prospective Study of Quantitative Changes in the Musculature of Children Treated with Radiation Therapy for Sarcomas International journal of radiation oncology, biology, physics(volume 63 issue Pages S443-S444), 2005 |
| Background | Krasin, M J; T.E. Merchant; S.L. Spunt; A.M. Davidoff; F. Navid; S. Wu; X. Xiong; C. Hua; L.E. Kun Early Results of a Prospective Study Delivering Limited Margin Radiotherapy for Pediatric Non-Rhabdo-Soft Tissue Sarcomas (NRSTS) and Aggressive Fibromatoses (AF) International journal of radiation oncology, biology, physics(volume 66 issue 3 Page S112), 2006 |
| Background | Krasin MJ, MD; Xiong X, PhD; Hua C, PhD; Marchese VG, PT, PhD; Cremer L, PT; Zhang L; Spunt SL, MD; Navid F, MD; Merchant TE, DO,PhD. A Model for Changes in Jaw Function in Children Following Therapeutic Irradiation of the Head and Neck presented at The 9th International Conference on Long-term Complications of Treatment of Children and Adolescents for Cancer, 2006 |
| 31987969 | Derived | Tinkle CL, Pappo A, Wu J, Mao S, Hua CH, Shulkin BL, McCarville MB, Kaste SC, Davidoff AM, Bahrami A, Green DM, Ness KK, Merchant TE, Spunt SL, Krasin MJ. Efficacy and Safety of Limited-Margin Conformal Radiation Therapy for Pediatric Rhabdomyosarcoma: Long-Term Results of a Phase 2 Study. Int J Radiat Oncol Biol Phys. 2020 May 1;107(1):172-180. doi: 10.1016/j.ijrobp.2020.01.011. Epub 2020 Jan 25. |
| Clinical Trials Open at St. Jude | View source |
| Ineligible |
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| Lost to Follow-up |
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| Still on Study |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra- and post-irradiation evaluations. Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated.
|
|
| Primary | Cumulative Incidence of Local Failures at 10 Years in Patients With Image Guided Radiation Therapy | The cumulative incidence of local failures is used to report the control of local failures in patients with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST). | Of 202 patients enrolled in the study, 199 patients were treated with radiation therapy. Three patients were off study before radiation therapy. Cumulative incidence of local failure is calculated from completion of RT to dates of local failure, distant failure (metastatic), the secondary malignancy, death, or off study (last contact) while distant failure (metastatic), the secondary malignancy, and death are considered as competing risks. | Posted | Number | 95% Confidence Interval | percentage of patients | 10- years follow-up after completion of therapy |
|
|
|
| Secondary | Changes in Growth Rate and Length of Bone, Bone Density, Development of Muscle (Muscle Function, e.g. Range of Motion), Occurrence of Organ Specific (e.g. Lung, Skin) CTC Measured Toxicities. | Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations. | Not Posted | Time to local failure (local control) over 5 years follow-up after completion of therapy | Participants |
| Secondary | Changes in Growth Rate and Length of Bone, Bone Density, Development of Muscle (Muscle Function, e.g. Range of Motion), Occurrence of Organ Specific (e.g. Lung, Skin) CTC Measured Toxicities. | Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations. | Not Posted | Time to local failure (local control) over 10 years follow-up after completion of therapy | Participants |
| Secondary | Muscle Function Over Time, PET, DCE-MR, T2* MR Quantitative Parameters. | Describe the severity and time course of radiation-induced changes in the soft tissues and adjacent organs, including muscle and subcutaneous tissues. | Not Posted | Change from baseline as well as comparison to non-treated side (when available) during the first 5 years after completion of therapy. | Participants |
| 2 |
| 199 |
| 9 |
| 199 |
| 50 |
| 199 |
| Wound-infectious | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hepatic-Other | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Musculoskeletal-Other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Chest pain (non-cardiac and non-pleuritic) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Tumor pain (onset or exacerbation of tumor pain due to treatment) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dermatology/Skin-Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Radiation dermatitis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gastrointestinal-Other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Mucositis due to radiation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hematuria (in the absence of vaginal bleeding) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Melena/GI bleeding | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Febrile neutropenia (fever of unknown origin | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Musculoskeletal-Other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| Keratitis (corneal inflammation/corneal ulceration | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| Ocular-Other | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain due to radiation | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Pain due to radiation, 900180 | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Pulmonary-Other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Renal/Genitourinary-Other | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
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| Sexual/Reproductive Function-Other | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Syndromes-Other | General disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |