Vincristine, Dactinomycin, and Cyclophosphamide With or W... | NCT00075582

NCT00075582

ID	Type	Description	Link
NCI-2009-00425	Registry Identifier	CTRP (Clinical Trial Reporting Program)
COG-ARST0331	Other Identifier	Children's Oncology Group
CDR0000347078	Other Identifier	Clinical Trials.gov
U10CA098543	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radiotherapy.

SECONDARY OBJECTIVES:

I. Determine local control rates in patients treated with this regimen. II. Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group III) and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor.

III. Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group.

REGIMEN I (subset 1 patients) [closed to accrual as of 08/13/2010: Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy**, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose.

REGIMEN II (subset 2 patients)[closed to accrual as of 9/23/2011]: Patients receive VAC chemotherapy and radiotherapy** as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin* IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46. Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy, and continued VA* chemotherapy. In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: *For both regimens, dactinomycin is omitted during radiotherapy.

NOTE: **Clinical Group I tumors and those with Clinical Group III uterine/cervix primary disease with negative nodes who have undergone a complete resection (i.e. hysterectomy) at Week 13 do not receive radiotherapy at Week 13

Patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.](streamdown:incomplete-link)

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regimen I (chemotherapy, radiotherapy)	Experimental	Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)	Drug: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate Radiation: radiation therapy
Regimen II (chemotherapy, radiotherapy, surgery)	Experimental	Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).	Procedure: conventional surgery Drug: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate Radiation: radiation therapy

Name	Type	Description	Arm Group Labels	Other Names
conventional surgery	Procedure	Some patients may undergo second-look surgery	Regimen II (chemotherapy, radiotherapy, surgery)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry	Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.	From enrollment up to 5 years
Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry	Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.	From enrollment up to 5 years
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry	Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.	From enrollment up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy	The local failure rate will be estimated using cumulative incidence curves.	From enrollment up to 5 years
Percentage of Patients With Delayed Surgical Procedures

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:
- Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010):
  - Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease
  - Stage 1 and clinical group III (gross residual disease) disease arising in the orbit
  - Stage 2 and clinical group I or II disease
- Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011):
  - Stage 1 and clinical group III disease arising in a non-orbit site
  - Stage 3 and clinical group I or II disease
Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)
- If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III
Prior regional lymph node sampling required for patients with extremity tumors
None of the following diagnoses:
- Intermediate-risk embryonal RMS
- Metastatic embryonal RMS
- Alveolar RMS
- Undifferentiated sarcoma
- RMS not otherwise specified (NOS)
- Other soft tissue sarcoma, including sarcoma NOS
Prior enrollment on clinical trial COG-D9902
Performance status - ECOG 0-2
Performance status - Karnofsky 50-100% (≥ 16 years old)
Performance status - Lansky 50-100% (< 16 years old)
Absolute neutrophil count at least 750/mm^3
Platelet count at least 75,000/mm^3 (transfusion independent)
Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
Creatinine* based on age/gender as follows:
- No greater than 0.8 mg/dL for patients age 5 and under
- No greater than 1.0 mg/dL for patients age 6 to 9
- No greater than 1.2 mg/dL for patients age 10 to 12
- No greater than 1.4 mg/dL for female patients age 13 and over
- No greater than 1.5 mg/dL for male patients age 13 to 15
- No greater than 1.7 mg/dL for male patients age 16 and over
Creatinine clearance* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
No prior chemotherapy (except for patients treated on the related intermediate-risk study)
Prior steroids allowed
No prior radiotherapy

Name	Affiliation	Role
David Walterhouse, MD	Children's Oncology Group	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Phoenix Childrens Hospital

PubMed Identifier	Type	Citation
	Background	Woolson RF (1981) Rank-tests and a one-sample log-rank test for comparing observed survival-data to a standard population. Biometrics 37: 687-696.
38603649	Derived	de Traux de Wardin H, Dermawan JK, Vanoli F, Jiang SC, Singer S, Chi P, Tap W, Wexler LH, Antonescu CR. NF1-Driven Rhabdomyosarcoma Phenotypes: A Comparative Clinical and Molecular Study of NF1-Mutant Rhabdomyosarcoma and NF1-Associated Malignant Triton Tumor. JCO Precis Oncol. 2024 Apr;8:e2300597. doi: 10.1200/PO.23.00597.
35829629

Label	URL
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Regimen I (Chemotherapy, Radiotherapy)	Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Regimen I (Chemotherapy, Radiotherapy)	Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
BG001	Regimen II (Chemotherapy, Radiotherapy, Surgery)	Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0007.69± 5.81 BG0015.02± 6.78 BG0027.11± 6.13

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00088 BG00155 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0012 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00038 BG0019 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000269 BG00177 BG002

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

Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry

Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.

Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.

Posted

Number

95% Confidence Interval

Estimated percentage of participants

From enrollment up to 5 years

ID	Title	Description
OG000	Regimen I (Chemotherapy, Radiotherapy)	Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
OG001	Regimen II (Chemotherapy, Radiotherapy, Surgery)	Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy

Units	Counts
Participants	OG000269 OG00169

Title

Denominators

Categories

Title	Measurements
	OG00087(82 to 91) OG00167(52 to 79)

Primary

Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry

Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.

All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.

Posted

Number

95% Confidence Interval

Estimated percentage of participants

From enrollment up to 5 years

ID	Title	Description
OG000	Regimen I (Chemotherapy, Radiotherapy)	Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy

Primary

Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry

Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.

All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.

Posted

Number

95% Confidence Interval

Estimated percentage of participants

From enrollment up to 5 years

ID	Title	Description
OG000	Regimen II (Chemotherapy, Radiotherapy, Surgery)	Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy

Secondary

Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy

The local failure rate will be estimated using cumulative incidence curves.

Patients who received reduced doses of radiation therapy.

Posted

Number

95% Confidence Interval

stimated percentage of participants

From enrollment up to 5 years

ID	Title	Description
OG000	Regimen I (Chemotherapy, Radiotherapy)	Stage I/II group IIA patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
OG001	Regimen II (Chemotherapy, Radiotherapy, Surgery)	Group III patients with orbit primary receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy

Secondary

Percentage of Patients With Delayed Surgical Procedures

The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.

All eligible Stage I Group III nonorbit primary and stage III group I/II patients

Posted

Number

95% Confidence Interval

percentage of participants

At 13 weeks after induction

ID	Title	Description
OG000	Regimen II (Stage I Group III Nonorbit or Stage III Group I/II	Stage I group III nonorbit primary or stage III group I/II patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy

Units	Counts

Secondary

Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose

The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.

Patients with Group III vaginal primary tumor

Posted

Number

Estimated percentage of participants

From enrollment up to 20 weeks

ID	Title	Description
OG000	Regimen II (Stage I Group III Nonorbit or Stage III Group I/II	Stage I group III nonorbit primary or stage III group I/II patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Regimen I (Chemotherapy, Radiotherapy)	Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy			1	272	74	272
EG001	Regimen II (Chemotherapy, Radiotherapy, Surgery)	Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy			1	70	27	70

Other Adverse Events

Term	Organ System	Statistical Information
Anemia	Blood and lymphatic system disorders	EG00014 events14 affected272 at risk EG0019 events9 affected70 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Febrile neutropenia	Blood and lymphatic system disorders	EG00014 events14 affected272 at risk EG0017 events7 affected70 at risk
Sinus tachycardia	Cardiac disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Photophobia	Eye disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Watering eyes	Eye disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Abdominal pain	Gastrointestinal disorders	EG0002 events2 affected272 at risk EG0011 events1 affected70 at risk
Constipation	Gastrointestinal disorders	EG0003 events3 affected272 at risk EG0011 events1 affected70 at risk
Diarrhea	Gastrointestinal disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Flatulence	Gastrointestinal disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Ileus	Gastrointestinal disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Mucositis oral	Gastrointestinal disorders	EG0002 events2 affected272 at risk EG0012 events2 affected70 at risk
Nausea	Gastrointestinal disorders	EG0003 events3 affected272 at risk EG0010 affected70 at risk
Oral pain	Gastrointestinal disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Small intestinal obstruction	Gastrointestinal disorders	EG0000 affected272 at risk EG0011 events1 affected70 at risk
Vomiting	Gastrointestinal disorders	EG0005 events5 affected272 at risk EG0010 affected70 at risk
Facial pain	General disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Fatigue	General disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Fever	General disorders	EG0005 events5 affected272 at risk EG0014 events4 affected70 at risk
Non-cardiac chest pain	General disorders	EG0001 events1 affected272 at risk EG0010 events0 affected70 at risk
Pain	General disorders	EG0002 events2 affected272 at risk EG0011 events1 affected70 at risk
Hepatobiliary disorders - Other	Hepatobiliary disorders	EG0002 events2 affected272 at risk EG0010 events0 affected70 at risk
Catheter related infection	Infections and infestations	EG0002 events2 affected272 at risk EG0011 events1 affected70 at risk
Conjunctivitis infective	Infections and infestations	EG0001 events1 affected272 at risk EG0010 events0 affected70 at risk
Infections and infestations - Other	Infections and infestations	EG0004 events4 affected272 at risk EG0015 events5 affected70 at risk
Rhinitis infective	Infections and infestations	EG0001 events1 affected272 at risk EG0010 events0 affected70 at risk
Upper respiratory infection	Infections and infestations	EG0001 events1 affected272 at risk EG0010 events0 affected70 at risk
Urinary tract infection	Infections and infestations	EG0002 events2 affected272 at risk EG0012 events2 affected70 at risk
Dermatitis radiation	Injury, poisoning and procedural complications	EG0001 events1 affected272 at risk EG0010 events0 affected70 at risk
Alanine aminotransferase increased	Investigations	EG0009 events9 affected272 at risk EG0012 events2 affected70 at risk
Alkaline phosphatase increased	Investigations	EG0000 events0 affected272 at risk EG0011 events1 affected70 at risk
Aspartate aminotransferase increased	Investigations	EG0007 events7 affected272 at risk EG0013 events3 affected70 at risk
Blood bilirubin increased	Investigations	EG0002 events2 affected272 at risk EG0010 affected70 at risk
Creatinine increased	Investigations	EG0001 events1 affected272 at risk EG0011 events1 affected70 at risk
Lymphocyte count decreased	Investigations	EG0002 events2 affected272 at risk EG0013 events3 affected70 at risk
Neutrophil count decreased	Investigations	EG00043 events43 affected272 at risk EG00115 events15 affected70 at risk
Platelet count decreased	Investigations	EG00010 events10 affected272 at risk EG0011 events1 affected70 at risk
Weight loss	Investigations	EG0002 events2 affected272 at risk EG0013 events3 affected70 at risk
White blood cell decreased	Investigations	EG00023 events23 affected272 at risk EG00110 events10 affected70 at risk
Anorexia	Metabolism and nutrition disorders	EG0000 events0 affected272 at risk EG0011 events1 affected70 at risk
Hypercalcemia	Metabolism and nutrition disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Hyperglycemia	Metabolism and nutrition disorders	EG0004 events4 affected272 at risk EG0014 events4 affected70 at risk
Hyperkalemia	Metabolism and nutrition disorders	EG0000 affected272 at risk EG0011 events1 affected70 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Hypocalcemia	Metabolism and nutrition disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Hypokalemia	Metabolism and nutrition disorders	EG0001 events1 affected272 at risk EG0011 events1 affected70 at risk
Hyponatremia	Metabolism and nutrition disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Neck pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Headache	Nervous system disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Peripheral motor neuropathy	Nervous system disorders	EG0004 events4 affected272 at risk EG0011 events1 affected70 at risk
Peripheral sensory neuropathy	Nervous system disorders	EG0004 events4 affected272 at risk EG0011 events1 affected70 at risk
Pyramidal tract syndrome	Nervous system disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Scrotal pain	Reproductive system and breast disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0000 affected272 at risk EG0011 events1 affected70 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	EG0003 events3 affected272 at risk EG0010 affected70 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	EG0002 events2 affected272 at risk EG0010 affected70 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	EG0001 events1 affected272 at risk EG0010 affected70 at risk
Vascular disorders - Other	Vascular disorders	EG0000 affected272 at risk EG0011 events1 affected70 at risk

ID	Term
D009217	Myosarcoma
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D012509	Sarcoma

ID	Term
D013514	Surgical Procedures, Operative
D003226	Congresses as Topic
D003609	Dactinomycin
D003520	Cyclophosphamide
D014750	Vincristine
D011878	Radiotherapy
D011827	Radiation

ID	Term
D009938	Organizations
D004472	Health Care Economics and Organizations
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D054836	Indolizidines
D007212	Indolizines
D013812	Therapeutics
D055585	Physical Phenomena