NCT00346164 · STUDY IN CONTEXT

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Probability of no relapse, secondary malignancy or death after 5 years since enrollment.

Ineligible patients are excluded as well as patients who were treated on the incorrect arm.

→

secondary · POSTED

Percentage of Arm D patients experiencing grade 4+ adverse events.

Excluding ineligible patients and patients not treated based on the protocol.

→

secondary · POSTED

Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.

Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.

→

secondary · POSTED

Percent tumor necrosis by pathology review.

Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.

→

secondary · POSTED

Probability of no relapse, secondary malignancy or death after 5 years since enrollment.

94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.

→

secondary · POSTED

Probability of no relapse, secondary malignancy or death after 5 years since enrollment

94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-soft-tissue-sarcoma
nct id: NCT00346164
trial label: Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0000
source section id
NCT00346164-om-0000
source outcome index
0
endpoint
Probability for Event Free Survival.
endpoint definition
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
time origin
5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Ineligible patients are excluded as well as patients who were treated on the incorrect arm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0001
source section id
NCT00346164-om-0001
source outcome index
1
endpoint
Toxicity Rate
endpoint definition
Percentage of Arm D patients experiencing grade 4+ adverse events.
time origin
13 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Excluding ineligible patients and patients not treated based on the protocol.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0002
source section id
NCT00346164-om-0002
source outcome index
2
endpoint
Complete or Partial Response Rate
endpoint definition
Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.
time origin
13 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0003
source section id
NCT00346164-om-0003
source outcome index
3
endpoint
Percent Tumor Necrosis
endpoint definition
Percent tumor necrosis by pathology review.
time origin
13 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0004
source section id
NCT00346164-om-0004
source outcome index
4
endpoint
Event Free Survival Probability Disease Extent
endpoint definition
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
time origin
5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0005
source section id
NCT00346164-om-0005
source outcome index
5
endpoint
Event Free Survival Probability Histologic Grade
endpoint definition
Probability of no relapse, secondary malignancy or death after 5 years since enrollment
time origin
5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0000
arm key
OG000
arm label
Arm A: No Adjuvant Treatment
regimen
Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only). clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery
analyzed count
205
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0000
arm key
OG001
arm label
Arm B: Low Risk; Adjuvant Radiotherapy
regimen
Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy. clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0000
arm key
OG002
arm label
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
regimen
High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV
analyzed count
110
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0000
arm key
OG003
arm label
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
regimen
High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV
analyzed count
196
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0001
arm key
OG000
arm label
Arm D
regimen
Intermediate \& High Risk; Neoadjuvant chemoradiotherapy
analyzed count
196
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0002
arm key
OG000
arm label
Arm D
regimen
Intermediate \& High Risk; Neoadjuvant chemoradiotherapy
analyzed count
142
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0003
arm key
OG000
arm label
Arm D
regimen
Intermediate \& High Risk; Neoadjuvant chemoradiotherapy
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0004
arm key
OG000
arm label
Non-metastatic
regimen
Non-metastatic
analyzed count
425
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0004
arm key
OG001
arm label
Metastatic
regimen
Metastatic
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0005
arm key
OG000
arm label
Histologic Grade 1
regimen
Histologic Grade 1
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0005
arm key
OG001
arm label
Histologic Grade 2
regimen
Histologic Grade 2
analyzed count
79
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0005#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
outcome key
om-0005
arm key
OG002
arm label
Histologic Grade 3
regimen
Histologic Grade 3
analyzed count
355
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00346164-om-0005#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
harm key
EG000
source section id
NCT00346164-ae
event group key
EG000
event group label
Arm A: No Adjuvant Treatment
serious affected
0
serious at risk
205
other affected
0
other at risk
205
frequency threshold
0
collection period
Source null
event definition
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
harm key
EG001
source section id
NCT00346164-ae
event group key
EG001
event group label
Arm B: Low Risk; Adjuvant Radiotherapy
serious affected
1
serious at risk
17
other affected
0
other at risk
17
frequency threshold
0
collection period
Source null
event definition
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
harm key
EG002
source section id
NCT00346164-ae
event group key
EG002
event group label
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
serious affected
1
serious at risk
110
other affected
2
other at risk
110
frequency threshold
0
collection period
Source null
event definition
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00346164
harm key
EG003
source section id
NCT00346164-ae
event group key
EG003
event group label
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
serious affected
3
serious at risk
196
other affected
7
other at risk
196
frequency threshold
0
collection period
Source null
event definition
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice