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Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Primary Purpose

Rhabdomyosarcoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Vincristine

Dactinomycin

Cyclophosphamide

Surgical Resection

Radiation

Bevacizumab

Sorafenib

Myeloid Growth Factor

Lymph Node Sampling

Irinotecan

Ifosfamide

Etoposide

Etoposide Phosphate

Doxorubicin

Dexrazoxane

^1^1C-methionine

About this trial

This is an interventional treatment trial for Rhabdomyosarcoma focused on measuring Rhabdomyosarcoma, Radiation therapy, Proton beam

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly diagnosed participants with localized rhabdomyosarcoma (RMS).
Must have either low-, intermediate-, or high-risk disease, defined as:
- Low-risk: Embryonal, botryoid, spindle cell tumors only (Subset 1: Stage 1, Group I; Stage 1 Group I; Stage 1 Group III orbital only; Stage 2 Group I; Stage 2 Group II) (Subset 2: Stage 1 Group III non orbit; Stage 3 Group I, II)
- Intermediate-risk: Embryonal, botryoid, or spindle cell RMS Stage 2 or 3 and Group III; Alveolar, undifferentiated, or anaplastic RMS: Stage 1-3, group I-I; I)
- High-risk: Embryonal, botryoid, spindle cell, alveolar, undifferentiated, or anaplastic RMS with metastatic disease at diagnosis (stage 4).
- Participants treated on this protocol in the low or intermediate risk arm who experience disease progression prior to week 13 will transfer to the high risk arm and proceed with high risk chemotherapy starting at week 1 of the protocol.
Age < 22 years (eligible until 22nd birthday)
Performance level corresponding to ECOG score of 0, 1, or 2. The Lansky performance score should be used for participants < 16 years
Participant has received no prior radiotherapy or chemotherapy for rhabdomyosarcoma (excluding steroids) unless an emergency situation requires local tumor treatment. Prior biopsy, surgical resection and lymph node sampling is allowed.
Initiation of chemotherapy is planned within 6 weeks (42 days) of the definitive biopsy or surgical resection.
Adequate bone marrow function defined as:
- Peripheral absolute neutrophil count (ANC) ≥ 750/μL
- Platelet count ≥ 75,000/μL (transfusion independent)
Adequate liver function defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age. Participants with biliary or hepatic primaries with bilirubin values greater than 1.5 x ULN may be enrolled on study if all other eligibility criteria are met.
Adequate renal function defined as:
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.732 or
- Serum creatinine based on age and gender
- Participants with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract.
Patients requiring emergency radiation therapy are eligible for enrollment on this study.
Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants ≥ 10 years of age or post-menarchal must have a negative serum or urine pregnancy test within 24 hours prior to beginning treatment. Female participants who are breast feeding must agree to stop breast feeding.
Sexually active patients of childbearing potential must be willing to use effective contraception during therapy and for at least 1 month after treatment is completed.
No evidence of active, uncontrolled infection.
All participants and/or their parents or legal guardians must sign a written informed consent.

Exclusion Criteria:

Participants who fail to meet one or more of the inclusion criteria will be excluded.

Inclusion Criteria for Contrast-Enhanced Ultrasound (CEUS) Sub-Study:

Newly diagnosis or suspected diagnosis of previously untreated participants with rhabdomyosarcoma (RMS). NOTE: Patients with suspected diagnosis of RMS may enroll on screening part of study but must have histologic diagnosis to enroll on treatment part of study.
Must have either intermediate-risk or high risk disease.
0-21 years of age.

Exclusion Criterial for CEUS Sub-Study:

Undergoing upfront surgical resection of the primary tumor.
History of allergy to Optison(TM) contrast agent or blood products.

Sites / Locations

University of Florida Proton Therapy Institute
Nemours Children's Clinic
St. Jude Children's Research Hospital
Cook Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Low-Risk, Subset 1

Low-Risk, Subset 2

Intermediate-Risk

High-Risk

Arm Description

Lymph node sampling will take place pretreatment and pre-surgery. Participants receive 12 weeks of chemotherapy (vincristine, dactinomycin and cyclophosphamide). They are then evaluated to determine how the tumor responded to treatment. Twelve additional weeks of chemotherapy (vincristine and dactinomycin) is given, followed by evaluation for tumor response. No further treatment is given, and participants are observed closely. Myeloid growth factor is given if needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Lymph node sampling will take place pretreatment and pre-surgery. Participants receive 12 weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide). The tumor is evaluated to determine how it responded to treatment. Radiation therapy and/or surgical resection is performed to destroy or remove the remaining tumor. Twelve additional weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide) is given, followed by evaluation for tumor response. If delayed for medical reasons, radiation therapy and/or surgical resection is done at this time. Participants then receive 16 weeks of additional chemotherapy (vincristine, dactinomycin and cyclophosphamide). No further treatment is given, and participants are observed closely. Myeloid growth factor will be given if needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Lymph node sampling takes place pretreatment and pre-surgery. Participants receive 12 weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide). The tumor is evaluated for treatment response. Radiation therapy and/or surgical resection is done. Twelve weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide) is followed by evaluation for tumor response. If delayed for medical reasons, radiation therapy and/or surgical resection is done at this time. Participants receive 16 weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide) followed by 12 weeks of maintenance treatment (bevacizumab, sorafenib, oral cyclophosphamide). No further treatment is given, and participants are observed closely. Myeloid growth factor is given if needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Lymph node sampling takes place pretreatment and pre-surgery. Participants receive 6 weeks (2 cycles) chemotherapy (vincristine and irinotecan). The tumor is evaluated for treatment response. 3 cycles of chemotherapy [vincristine, doxorubicin, cyclophosphamide/ifosfamide, etoposide (or etoposide phosphate) (VDC/IE)] are given. Dexrazoxane is given prior to each dose of doxorubicin. Radiation therapy begins at week 4 or 20 (depending on tumor location) while receiving vincristine and irinotecan. 2 cycles of VDC/IE, 4 cycles of modified vincristine, dactinomycin, cyclophosphamide (VAC), then 2 cycles of modified vincristine/irinotecan (total of 54 weeks). High risk participants also receive additional maintenance therapy beginning week 55 with anti-angiogenic chemotherapy (bevacizumab, sorafenib, cyclophosphamide). Myeloid growth factor is given as needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Outcomes

Primary Outcome Measures

Event-free survival (intermediate risk arm)

To estimate event-free survival for intermediate risk participants treated by vincristine-dactinomycin-cyclophosphamide (VAC) with the addition of maintenance anti-angiogenic therapy

Secondary Outcome Measures

Event-free survival (high risk arm)

To estimate event-free survival for high risk participants.

Rate of false negative and false positive the sentinel lymph node procedure (low and intermediate risk arms)

Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection.

Rate of false negative and false positive the sentinel lymph node procedure (high risk arm)

Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection.

Local failure rate (low and intermediate risk arms)

Maintain a high local control rate in participants treated with surgery and / or limited volume proton and photon radiation without dose escalation

Local failure rate (high risk arm)

Maintain a high local control rate in participants treated with surgery and / or limited volume proton and photon radiation without dose escalation

Patterns of failure (low and intermediate risk arms)

Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume

Patterns of failure (high risk arm)

Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume

Number of patients that complete all cycles of maintenance chemotherapy (intermediate risk arm)

Establish the feasibility of delivering 4 cycles of maintenance antiangiogenic chemotherapy (bevacizumab / sorafenib / low dose cyclophosphamide) in intermediate risk patients following standard chemotherapy.

Number of patients that complete all cycles of maintenance chemotherapy (high risk arm)

Establish the feasibility of delivering 4 cycles of maintenance antiangiogenic chemotherapy (bevacizumab / sorafenib / low dose cyclophosphamide) in high risk patients following standard chemotherapy.

Incidence of CTC grade 3 and higher toxicities related to proton bream therapy (low and intermediate and high risk arms)

Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2 toxicities) related to proton beam therapy.

Full Information

NCT ID

NCT01871766

First Posted

May 30, 2013

Last Updated

September 6, 2023

Sponsor

St. Jude Children's Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01871766

Brief Title

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Official Title

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 4, 2013 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

June 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Jude Children's Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will treat participants with newly diagnosed, low, intermediate and high risk rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified dose chemotherapy, radiation and surgical resection. Intermediate and high risk participants will receive an additional 12 weeks (4 cycles) of maintenance therapy with anti-angiogenic chemotherapy. PRIMARY OBJECTIVE: Estimate event-free survival for intermediate risk participants treated with vincristine, dactinomycin and cyclophosphamide with the addition of maintenance anti-angiogenic therapy. SECONDARY OBJECTIVES: Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection. Maintain a high local control rate in participants treated with surgery and/or limited volume proton and photon radiation without dose escalation. Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume. Establish the feasibility of delivering 4 cycles of maintenance anti-angiogenic chemotherapy in intermediate and high risk patients following standard chemotherapy. Estimate the event free survival for high risk patients receiving interval dose compressed therapy and maintenance anti-angiogenic therapy. Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2 toxicities) related to proton beam therapy.

Detailed Description

Participants will be stratified based on both a pretreatment staging system and a post-surgery surgico/pathologic clinical grouping system. Treatment for low-risk (subset 1) participants will consist of chemotherapy and radiation. Low-risk (subset 2) and intermediate-risk participants will receive chemotherapy and radiation and/or undergo surgery to destroy/remove the tumor. Intermediate-risk participants will also receive 16 weeks of maintenance chemotherapy. High-risk participants will receive chemotherapy and radiation therapy. High-risk participants will also receive additional maintenance therapy with anti-angiogenic chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhabdomyosarcoma

Keywords

Rhabdomyosarcoma, Radiation therapy, Proton beam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low-Risk, Subset 1

Arm Type

Experimental

Arm Description

Arm Title

Low-Risk, Subset 2

Arm Type

Experimental

Arm Description

Arm Title

Intermediate-Risk

Arm Type

Experimental

Arm Description

Arm Title

High-Risk

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

Oncovin®

Intervention Description

Dosage and route of administration: < 1 year of age=0.025 mg/kg intravenously (IV) > 1 year and < 3 years= 0.05 mg/kg IV ≥ 3 years=1.5 mg/m^2 IV. Maximum dose 2 mg in all participants.

Intervention Type

Drug

Intervention Name(s)

Dactinomycin

Other Intervention Name(s)

Actinomycin-D, Cosmegen®

Intervention Description

Dosage and route of administration: < 1 year=0.025 mg/kg IV push ≥ 1 year=0.045 mg/kg IV push over 1 to 5 minutes.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cytoxan(R)

Intervention Description

Dosage and route of administration: During VAC chemotherapy: < 3 years of age = 40 mg/kg IV ≥ 3 years of age = 1200 mg/m^2 IV, with MESNA. During maintenance for intermediate-risk participants: oral cyclophosphamide 50 mg/m^2/dose/day (liquid or tablet)

Intervention Type

Procedure

Intervention Name(s)

Surgical Resection

Other Intervention Name(s)

Surgery

Intervention Description

Surgery will be performed for the primary site tumor with the goal of removing tumor cells while maintaining function in the organ or adjacent organs involved.

Intervention Type

Procedure

Intervention Name(s)

Radiation

Other Intervention Name(s)

Proton Beam Radiation, External Beam Radiation, Brachytherapy

Intervention Description

Radiation therapy will be delivered at approximately week 13 (intermediate risk) or week 19 (high risk) after initiation of chemotherapy. Certain patients will receive radiation at week 4.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

rhuMab, VEGF, Avastin®

Intervention Description

Dosage and route of administration: 15 mg/kg/dose/day IV.

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Other Intervention Name(s)

Nexavar®

Intervention Description

Dosage and route of administration: 90 mg/m^2/dose twice daily.

Intervention Type

Drug

Intervention Name(s)

Myeloid Growth Factor

Other Intervention Name(s)

G-CSF, Filgrastim, Pegfilgrastim

Intervention Description

If a participant's chemotherapy has been delayed or modified for hematologic toxicity, or if participant experiences a significant life-threatening toxicity due to bone marrow suppression, myeloid growth factor (either filgrastim or peg-filgrastim) will be given per institutional practice. High Risk participants receive filgrastim 5 micrograms/kg/day (maximum 300 micrograms) subcutaneously beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/µL whichever comes last. Sargramostim or peg-filgrastim may not be used.

Intervention Type

Procedure

Intervention Name(s)

Lymph Node Sampling

Intervention Description

Clinical and/or imaging evaluation of regional lymph nodes will be conducted pretreatment and preoperatively as part of staging. This will aid in determining the efficacy of this procedure in defining involved lymphatics in "at risk" patients.

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

Camptosar ®

Intervention Description

Dosage and Route Administration: During interval compressed therapy - irinotecan 50mg/m^2 IV (maximum dose 100 mg/day) daily x 5.

Intervention Type

Drug

Intervention Name(s)

Ifosfamide

Other Intervention Name(s)

Ifex ®

Intervention Description

Dosage and Route of Administration: During interval compressed therapy - Age > 1 year: 1800 mg/m^2/day IV x 5 Age <1 year: treat with 50% doses calculated on a m^2 basis.

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

VP-16, Vepesid®

Intervention Description

Dosage and Route of Administration: Age >1 year 100 mg/m^2/day IV x 5 Age < 1 year treat with 50% doses calculated on a m^2 basis

Intervention Type

Drug

Intervention Name(s)

Etoposide Phosphate

Other Intervention Name(s)

Etopophos®

Intervention Description

Dosage and Route of Administration: Used in substitution for etoposide in participants who experience allergic reaction. It will be administered 100 mg/m^2/day IV.

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

Adriamycin®

Intervention Description

Dosage and route of Administration: Age ≥1 year, 37.5 mg/m^2 IV over 1 hour x 2 days Age <1 year, 18.75 mg/m^2 (i.e., a 50% dose reduction) IV over 1 hour x 2 days.

Intervention Type

Drug

Intervention Name(s)

Dexrazoxane

Other Intervention Name(s)

Zinecard

Intervention Description

Dosage and Route of Administration: Dexrazoxane dose should be 10x that of doxorubicin. Age ≥1 year, 375 mg/m^2 IV over 15-30 minutes Age <1 year, 187l.5 mg/m^2 (i.e., a 50% dose reduction) IV over 15-30 minutes.

Intervention Type

Drug

Intervention Name(s)

^1^1C-methionine

Other Intervention Name(s)

Contrast Media

Intervention Description

Participants receive ^1^1C-methionine to relate the distribution, intensity and change in ^1^1C-methionine CTPET imaging of the primary site to tumor control and patient outcome.

Primary Outcome Measure Information:

Title

Event-free survival (intermediate risk arm)

Description

To estimate event-free survival for intermediate risk participants treated by vincristine-dactinomycin-cyclophosphamide (VAC) with the addition of maintenance anti-angiogenic therapy

Time Frame

2 years after last intermediate risk arm enrollment

Secondary Outcome Measure Information:

Title

Event-free survival (high risk arm)

Description

To estimate event-free survival for high risk participants.

Time Frame

5 years after last high-risk arm enrollment

Title

Rate of false negative and false positive the sentinel lymph node procedure (low and intermediate risk arms)

Description

Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection.

Time Frame

2 years after last low or intermediate arm enrollment

Title

Rate of false negative and false positive the sentinel lymph node procedure (high risk arm)

Description

Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection.

Time Frame

5 years after last high risk arm enrollment

Title

Local failure rate (low and intermediate risk arms)

Description

Maintain a high local control rate in participants treated with surgery and / or limited volume proton and photon radiation without dose escalation

Time Frame

2 years after last low or intermediate risk arm enrollment

Title

Local failure rate (high risk arm)

Description

Maintain a high local control rate in participants treated with surgery and / or limited volume proton and photon radiation without dose escalation

Time Frame

5 years after last high risk arm enrollment

Title

Patterns of failure (low and intermediate risk arms)

Description

Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume

Time Frame

2 years after last low or intermediate risk arm enrollment

Title

Patterns of failure (high risk arm)

Description

Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume

Time Frame

5 years after last high risk arm enrollment

Title

Number of patients that complete all cycles of maintenance chemotherapy (intermediate risk arm)

Description

Time Frame

2 years after last low or intermediate risk arm enrollment

Title

Number of patients that complete all cycles of maintenance chemotherapy (high risk arm)

Description

Time Frame

5 years after last high risk arm enrollment

Title

Incidence of CTC grade 3 and higher toxicities related to proton bream therapy (low and intermediate and high risk arms)

Description

Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2 toxicities) related to proton beam therapy.

Time Frame

2 years after last enrollment

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly diagnosed participants with localized rhabdomyosarcoma (RMS). Must have either low-, intermediate-, or high-risk disease, defined as: Low-risk: Embryonal, botryoid, spindle cell tumors only (Subset 1: Stage 1, Group I; Stage 1 Group I; Stage 1 Group III orbital only; Stage 2 Group I; Stage 2 Group II) (Subset 2: Stage 1 Group III non orbit; Stage 3 Group I, II) Intermediate-risk: Embryonal, botryoid, or spindle cell RMS Stage 2 or 3 and Group III; Alveolar, undifferentiated, or anaplastic RMS: Stage 1-3, group I-I; I) High-risk: Embryonal, botryoid, spindle cell, alveolar, undifferentiated, or anaplastic RMS with metastatic disease at diagnosis (stage 4). Participants treated on this protocol in the low or intermediate risk arm who experience disease progression prior to week 13 will transfer to the high risk arm and proceed with high risk chemotherapy starting at week 1 of the protocol. Age < 22 years (eligible until 22nd birthday) Performance level corresponding to ECOG score of 0, 1, or 2. The Lansky performance score should be used for participants < 16 years Participant has received no prior radiotherapy or chemotherapy for rhabdomyosarcoma (excluding steroids) unless an emergency situation requires local tumor treatment. Prior biopsy, surgical resection and lymph node sampling is allowed. Initiation of chemotherapy is planned within 6 weeks (42 days) of the definitive biopsy or surgical resection. Adequate bone marrow function defined as: Peripheral absolute neutrophil count (ANC) ≥ 750/μL Platelet count ≥ 75,000/μL (transfusion independent) Adequate liver function defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age. Participants with biliary or hepatic primaries with bilirubin values greater than 1.5 x ULN may be enrolled on study if all other eligibility criteria are met. Adequate renal function defined as: Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.732 or Serum creatinine based on age and gender Participants with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract. Patients requiring emergency radiation therapy are eligible for enrollment on this study. Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants ≥ 10 years of age or post-menarchal must have a negative serum or urine pregnancy test within 24 hours prior to beginning treatment. Female participants who are breast feeding must agree to stop breast feeding. Sexually active patients of childbearing potential must be willing to use effective contraception during therapy and for at least 1 month after treatment is completed. No evidence of active, uncontrolled infection. All participants and/or their parents or legal guardians must sign a written informed consent. Exclusion Criteria: Participants who fail to meet one or more of the inclusion criteria will be excluded. Inclusion Criteria for Contrast-Enhanced Ultrasound (CEUS) Sub-Study: Newly diagnosis or suspected diagnosis of previously untreated participants with rhabdomyosarcoma (RMS). NOTE: Patients with suspected diagnosis of RMS may enroll on screening part of study but must have histologic diagnosis to enroll on treatment part of study. Must have either intermediate-risk or high risk disease. 0-21 years of age. Exclusion Criterial for CEUS Sub-Study: Undergoing upfront surgical resection of the primary tumor. History of allergy to Optison(TM) contrast agent or blood products.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew J. Krasin, MD

Organizational Affiliation

St. Jude Children's Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida Proton Therapy Institute

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32206

Country

United States

Facility Name

Nemours Children's Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

St. Jude Children's Research Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

Cook Children's Medical Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35483358

Citation

Patel AG, Chen X, Huang X, Clay MR, Komorova N, Krasin MJ, Pappo A, Tillman H, Orr BA, McEvoy J, Gordon B, Blankenship K, Reilly C, Zhou X, Norrie JL, Karlstrom A, Yu J, Wodarz D, Stewart E, Dyer MA. The myogenesis program drives clonal selection and drug resistance in rhabdomyosarcoma. Dev Cell. 2022 May 23;57(10):1226-1240.e8. doi: 10.1016/j.devcel.2022.04.003. Epub 2022 Apr 27.

Results Reference

derived

Links:

URL

http://www.stjude.org

Description

St. Jude Children's Research Hospital

URL

http://www.stjude.org/protocols

Description

Clinical Trials Open at St. Jude

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Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

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