Trial Outcomes & Findings for Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma (NCT NCT00072280)
NCT ID: NCT00072280
Last Updated: 2014-09-30
Results Overview
Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)
Results posted on
2014-09-30
Participant Flow
Participant milestones
| Measure |
Chemotherapy Plus Possible Surgery
Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)
|
Surgery Only
Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
|
|---|---|---|
|
Treatment
STARTED
|
3
|
4
|
|
Treatment
COMPLETED
|
2
|
2
|
|
Treatment
NOT COMPLETED
|
1
|
2
|
|
Follow-up
STARTED
|
2
|
2
|
|
Follow-up
COMPLETED
|
0
|
0
|
|
Follow-up
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Chemotherapy Plus Possible Surgery
Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)
|
Surgery Only
Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
|
|---|---|---|
|
Treatment
Found ineligible
|
1
|
2
|
|
Follow-up
Early termination of study
|
2
|
2
|
Baseline Characteristics
Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
Baseline characteristics by cohort
| Measure |
Chemotherapy Plus Possible Surgery
n=3 Participants
Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)
|
Surgery Only
n=4 Participants
Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Less than 6 months
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
6 months or more
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)Population: By protocol design, only eligible patients were considered in the evaluation for the primary outcome measure. One (1) patient was found ineligible, leaving two (2) for the analysis population.
Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).
Outcome measures
| Measure |
Chemotherapy Plus Possible Surgery
n=2 Participants
Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)
|
|---|---|
|
Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm
Failed
|
1 participants
|
|
Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm
Failure-free through 5 years of follow-up
|
0 participants
|
|
Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm
Failure-free at cutoff (if < 5 years follow-up)
|
1 participants
|
|
Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm
Withdrew from study
|
0 participants
|
|
Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm
Lost to follow-up
|
0 participants
|
Adverse Events
Chemotherapy Plus Possible Surgery
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Surgery Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chemotherapy Plus Possible Surgery
n=2 participants at risk
Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)
|
Surgery Only
n=2 participants at risk
Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2
All eligible patients were considered in the evaluation of adverse events (AEs). Three (3) patients were considered ineligible. All other patients (two on each study arm) are included in AE reporting.
|
0.00%
0/2
All eligible patients were considered in the evaluation of adverse events (AEs). Three (3) patients were considered ineligible. All other patients (two on each study arm) are included in AE reporting.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
50.0%
1/2
All eligible patients were considered in the evaluation of adverse events (AEs). Three (3) patients were considered ineligible. All other patients (two on each study arm) are included in AE reporting.
|
0.00%
0/2
All eligible patients were considered in the evaluation of adverse events (AEs). Three (3) patients were considered ineligible. All other patients (two on each study arm) are included in AE reporting.
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2
All eligible patients were considered in the evaluation of adverse events (AEs). Three (3) patients were considered ineligible. All other patients (two on each study arm) are included in AE reporting.
|
0.00%
0/2
All eligible patients were considered in the evaluation of adverse events (AEs). Three (3) patients were considered ineligible. All other patients (two on each study arm) are included in AE reporting.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER