NCT01079832 · STUDY IN CONTEXT
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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
The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
Median disease free survival
Length of time patients survived at study end.
Quality of Life
Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Quality of Life
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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- qol key
- qol-0003
- source section id
- NCT01079832-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life
- measure definition
- Source null
- time frame
- After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participant surveys were unreliably returned to investigators, making this analysis not meaningful.
- 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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- trial label
- Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic 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
- 5
- harms Count
- 1
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0000
- source section id
- NCT01079832-om-0000
- source outcome index
- 0
- endpoint
- Acute Toxicity Rate
- endpoint definition
- The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
- time origin
- at 6 months after treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to treat
- 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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0001
- source section id
- NCT01079832-om-0001
- source outcome index
- 1
- endpoint
- Disease-free Survival
- endpoint definition
- Median disease free survival
- time origin
- completion of study at 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to treat
- 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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0002
- source section id
- NCT01079832-om-0002
- source outcome index
- 2
- endpoint
- Median Overall Survival
- endpoint definition
- Length of time patients survived at study end.
- time origin
- 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to treat
- 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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0003
- source section id
- NCT01079832-om-0003
- source outcome index
- 3
- endpoint
- Quality of Life
- endpoint definition
- Quality of Life
- time origin
- After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participant surveys were unreliably returned to investigators, making this analysis not meaningful.
- 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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0004
- source section id
- NCT01079832-om-0004
- source outcome index
- 4
- endpoint
- Clinical Response Rate
- endpoint definition
- Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).
- time origin
- at 6 months from study entry
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to treat
- 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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I: CyberKnife Radiosurgery
- regimen
- Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01079832-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I: CyberKnife Radiosurgery
- regimen
- Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01079832-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I: CyberKnife Radiosurgery
- regimen
- Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01079832-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I: CyberKnife Radiosurgery
- regimen
- Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01079832-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I: CyberKnife Radiosurgery
- regimen
- Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01079832-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- harm key
- EG000
- source section id
- NCT01079832-ae
- event group key
- EG000
- event group label
- Arm I: CyberKnife Radiosurgery
- serious affected
- 3
- serious at risk
- 50
- other affected
- 34
- other at risk
- 50
- frequency threshold
- 5
- collection period
- Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
- 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-cervical-cancer-jobevne-5a0678d2
- nct id
- NCT01079832
- qol key
- qol-0003
- source section id
- NCT01079832-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life
- measure definition
- Source null
- time frame
- After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participant surveys were unreliably returned to investigators, making this analysis not meaningful.
- 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
Triangle