Trial · NCT00075582

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

NCT00075582, Phase 3, Completed, Children's Oncology Group; results first posted 2014-04-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma. Trials, record NCT00075582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075582

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
NCT number: NCT00075582
Status: Completed
Phases: Phase 3
Enrollment: 390 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma
Interventions: conventional surgery, dactinomycin, cyclophosphamide, vincristine sulfate, radiation therapy
First posted: 2004-01-12
Last updated: 2021-11-19
Results first posted: 2014-04-11

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry	From enrollment up to 5 years	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.
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	From enrollment up to 5 years	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.
Primary	Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry	From enrollment up to 5 years	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.
Secondary	Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy	From enrollment up to 5 years	The local failure rate will be estimated using cumulative incidence curves.
Secondary	Percentage of Patients With Delayed Surgical Procedures	At 13 weeks after induction	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.
Secondary	Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose	From enrollment up to 20 weeks	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry	From enrollment up to 5 years	Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.	Estimated percentage of participants	NUMBER
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	From enrollment up to 5 years	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.	Estimated percentage of participants	NUMBER
PRIMARY	Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry	From enrollment up to 5 years	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.	Estimated percentage of participants	NUMBER
SECONDARY	Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy	From enrollment up to 5 years	Patients who received reduced doses of radiation therapy.	stimated percentage of participants	NUMBER
SECONDARY	Percentage of Patients With Delayed Surgical Procedures	At 13 weeks after induction	All eligible Stage I Group III nonorbit primary and stage III group I/II patients	percentage of participants	NUMBER
SECONDARY	Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose	From enrollment up to 20 weeks	Patients with Group III vaginal primary tumor	Estimated percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry	Regimen I (Chemotherapy, Radiotherapy)	87	95% Confidence Interval 82 to 91	Estimated percentage of participants
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry	Regimen II (Chemotherapy, Radiotherapy, Surgery)	67	95% Confidence Interval 52 to 79	Estimated percentage of participants
Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry	Regimen I (Chemotherapy, Radiotherapy)	90	95% Confidence Interval 72 to 97	Estimated percentage of participants
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry	Regimen II (Chemotherapy, Radiotherapy, Surgery)	67	95% Confidence Interval 52 to 79	Estimated percentage of participants
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy	Regimen I (Chemotherapy, Radiotherapy)	0.081	95% Confidence Interval 0.046 to 0.116	stimated percentage of participants
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy	Regimen II (Chemotherapy, Radiotherapy, Surgery)	0.115	95% Confidence Interval 0.035 to 0.195	stimated percentage of participants
Percentage of Patients With Delayed Surgical Procedures	Regimen II (Stage I Group III Nonorbit or Stage III Group I/II	0.49	95% Confidence Interval 0.34 to 0.64	percentage of participants
Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose	Regimen II (Stage I Group III Nonorbit or Stage III Group I/II	0		Estimated percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen I (Chemotherapy, Radiotherapy)	305
Overall Study	STARTED	Regimen II (Chemotherapy, Radiotherapy, Surgery)	85
Overall Study	COMPLETED	Regimen I (Chemotherapy, Radiotherapy)	255
Overall Study	COMPLETED	Regimen II (Chemotherapy, Radiotherapy, Surgery)	50
Overall Study	NOT COMPLETED	Regimen I (Chemotherapy, Radiotherapy)	50
Overall Study	NOT COMPLETED	Regimen II (Chemotherapy, Radiotherapy, Surgery)	35

Source ClinicalTrials.gov

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Regimen I (Chemotherapy, Radiotherapy)	14	272	14
other	Anemia	Blood and lymphatic system disorders	Regimen II (Chemotherapy, Radiotherapy, Surgery)	9	70	9
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Regimen I (Chemotherapy, Radiotherapy)	1	272	1
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Regimen II (Chemotherapy, Radiotherapy, Surgery)	0	70
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen I (Chemotherapy, Radiotherapy)	14	272	14
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen II (Chemotherapy, Radiotherapy, Surgery)	7	70	7
other	Sinus tachycardia	Cardiac disorders	Regimen I (Chemotherapy, Radiotherapy)	1	272	1
other	Sinus tachycardia	Cardiac disorders	Regimen II (Chemotherapy, Radiotherapy, Surgery)	0	70
other	Photophobia	Eye disorders	Regimen I (Chemotherapy, Radiotherapy)	1	272	1
other	Photophobia	Eye disorders	Regimen II (Chemotherapy, Radiotherapy, Surgery)	0	70

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen I (Chemotherapy, Radiotherapy)
Total, all-cause mortality	Regimen II (Chemotherapy, Radiotherapy, Surgery)
Total, other adverse events	Regimen I (Chemotherapy, Radiotherapy)	74	272
Total, other adverse events	Regimen II (Chemotherapy, Radiotherapy, Surgery)	27	70
Total, serious adverse events	Regimen I (Chemotherapy, Radiotherapy)	1	272
Total, serious adverse events	Regimen II (Chemotherapy, Radiotherapy, Surgery)	1	70

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35829629	DERIVED	PubMed
38603649	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Regimen I (Chemotherapy, Radiotherapy) vs Regimen II (Chemotherapy, Radiotherapy, Surgery): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00075582

GET https://conductscience.org/api/trials/v1/NCT00075582/events?page=2

API reference For AI assistants