Trial Outcomes & Findings for Radiation Therapy to Treat Musculoskeletal Tumors (NCT NCT00186992)

Last Updated: 2025-03-06

Results Overview

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).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

202 participants

Primary outcome timeframe

5-years follow-up after completion of therapy.

Results posted on

2025-03-06

Participant Flow

202 participants were enrolled between January 10, 2003 and July, 9, 2014.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	202
Overall Study COMPLETED	167
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	5
Overall Study Physician's discretion	13
Overall Study PI Discretion	4
Overall Study Ineligible	2
Overall Study Lost to Follow-up	2
Overall Study Still on Study	9

Baseline Characteristics

Radiation Therapy to Treat Musculoskeletal Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=202 Participants 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.
Age, Continuous	11.84 Years STANDARD_DEVIATION 6.11 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	45 Participants n=5 Participants
Race/Ethnicity, Customized Black and White	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Race/Ethnicity, Customized White	151 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5-years follow-up after completion of therapy.

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment n=199 Participants 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.
Cumulative Incidence of Local Failures at 5 Years in Patients With Image Guided Radiation Therapy	13.37 percentage of patients Interval 9.02 to 18.57

PRIMARY outcome

Timeframe: 10- years follow-up after completion of therapy

Outcome measures

Outcome measures
Measure	Treatment n=199 Participants 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.
Cumulative Incidence of Local Failures at 10 Years in Patients With Image Guided Radiation Therapy	14.31 percentage of patients Interval 9.68 to 19.81

SECONDARY outcome

Timeframe: Time to local failure (local control) over 5 years follow-up after completion of therapy

Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to local failure (local control) over 10 years follow-up after completion of therapy

Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline as well as comparison to non-treated side (when available) during the first 5 years after completion of therapy.

Describe the severity and time course of radiation-induced changes in the soft tissues and adjacent organs, including muscle and subcutaneous tissues.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 9 serious events

Other events: 50 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=199 participants at risk 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.
Ear and labyrinth disorders Middle ear/hearing	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Skin and subcutaneous tissue disorders Wound-infectious	1.0% 2/199 • Number of events 2 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Hepatobiliary disorders Hepatic-Other	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal-Other	1.5% 3/199 • Number of events 3 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
General disorders Chest pain (non-cardiac and non-pleuritic)	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
General disorders Tumor pain (onset or exacerbation of tumor pain due to treatment)	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.

Other adverse events

Other adverse events
Measure	Treatment n=199 participants at risk 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.
General disorders Weight loss	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other	1.0% 2/199 • Number of events 2 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Skin and subcutaneous tissue disorders Radiation dermatitis	7.0% 14/199 • Number of events 15 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Gastrointestinal disorders Gastrointestinal-Other	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Gastrointestinal disorders Mucositis due to radiation	2.0% 4/199 • Number of events 4 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Blood and lymphatic system disorders Hematuria (in the absence of vaginal bleeding)	1.0% 2/199 • Number of events 2 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Blood and lymphatic system disorders Melena/GI bleeding	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Infections and infestations Febrile neutropenia (fever of unknown origin	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal-Other	2.0% 4/199 • Number of events 4 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Nervous system disorders Syncope	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Eye disorders Cataract	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Eye disorders Keratitis (corneal inflammation/corneal ulceration	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Eye disorders Ocular-Other	0.50% 1/199 • Number of events 2 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
General disorders Headache	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
General disorders Pain due to radiation	1.0% 2/199 • Number of events 2 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
General disorders Pain due to radiation, 900180	2.5% 5/199 • Number of events 5 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Renal and urinary disorders Renal/Genitourinary-Other	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Renal and urinary disorders Urinary retention	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Reproductive system and breast disorders Sexual/Reproductive Function-Other	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
General disorders Syndromes-Other	0.50% 1/199 • Number of events 1 • Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.

Additional Information

Matthew Krasin, MD

St. Jude Children's Research Hospital

Phone: (901) 595-3226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place