TriangleNCT00025506 · STUDY IN CONTEXT
Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
The observed length of life from entry into the study to death or the date of last contact.
Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction. Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work. Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
Reported safety
Quality of life and patient-reported measures
FACT · Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- qol key
- qol-0008
- source section id
- NCT00025506-om-0008
- source outcome index
- 8
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF
- measure definition
- Source null
- time frame
- Up to 5 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- trial label
- Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0000
- source section id
- NCT00025506-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) > 6 Months
- endpoint definition
- Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
- time origin
- Every other cycle for 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients.
- 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-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0001
- source section id
- NCT00025506-om-0001
- source outcome index
- 1
- endpoint
- Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
- endpoint definition
- Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
- time origin
- Each cycle during treatment and 30 days after the last treatment (average 4 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and evaluable patients
- 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-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0002
- source section id
- NCT00025506-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival
- endpoint definition
- Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
- time origin
- Every other cycle until progression or death, up to 5 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients
- 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-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0003
- source section id
- NCT00025506-om-0003
- source outcome index
- 3
- endpoint
- Tumor Response
- endpoint definition
- RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
- time origin
- For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients.
- 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-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0004
- source section id
- NCT00025506-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival
- endpoint definition
- The observed length of life from entry into the study to death or the date of last contact.
- time origin
- From study entry to death or last contact, up to 5 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients.
- 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-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0005
- source section id
- NCT00025506-om-0005
- source outcome index
- 5
- endpoint
- Initial Performance Status
- endpoint definition
- Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction. Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work. Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
- time origin
- baseline
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and evaluable patients
- 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-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Thalidomide
- regimen
- Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Grade 0
- regimen
- Number of patients who did not experience the adverse event.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Grade 1
- regimen
- Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Grade 2
- regimen
- Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Grade 3
- regimen
- Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Grade 4
- regimen
- Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Thalidomide
- regimen
- Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Thalidomide
- regimen
- Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Thalidomide
- regimen
- Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Thalidomide
- regimen
- Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025506-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- harm key
- EG000
- source section id
- NCT00025506-ae
- event group key
- EG000
- event group label
- Thalidomide
- serious affected
- 15
- serious at risk
- 45
- other affected
- 45
- other at risk
- 45
- frequency threshold
- 0
- collection period
- All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
- event definition
- Source null
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-uterine-sarcoma-recurrent-8e0b2edc
- nct id
- NCT00025506
- qol key
- qol-0008
- source section id
- NCT00025506-om-0008
- source outcome index
- 8
- instrument
- FACT
- instrument basis
- matched 'factor' in the study's own wording
- scale title
- Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF
- measure definition
- Source null
- time frame
- Up to 5 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice