Fallopian Tube CancerPhase 2NCT01079832
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
A Phase 2 study testing stereotactic radiosurgery and quality-of-life assessment in people with Fallopian Tube Cancer and Ovarian Sarcoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in treating women with advanced or recurrent gynecological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Sarcoma, Ovarian Stromal Cancer
- What is being tested?
- stereotactic radiosurgery and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven gynecologic malignancy
- No prior cryosurgery or radiofrequency ablation, in target lesion
- Patient is able to give and sign study specific informed consent
- Measurable disease, according to RECIST criteria
- Laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include CBC, basic metabolic panel, BUN, and creatinine
- >= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy
- ECOG performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients
Who cannot join
- Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded
- Any patient with active Crohn's disease or active ulcerative colitis is excluded
- Major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in treating women with advanced or recurrent gynecological malignancies.
Read the detailed description
PRIMARY OBJECTIVES:
- The primary goal of this study is to estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period following CyberKnife radiosurgery for gynecologic cancers.
II. To evaluate clinical response to radio-surgery for gynecologic tumors.
III. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O, FACT-Cx or FACT-V) and to evaluate patient's level of pain.
SECONDARY OBJECTIVES:
- As a secondary objective, toxicities during the 2 years following CyberKnife radiosurgery will also be described.
OUTLINE:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
- Conditions
- Fallopian Tube Cancer, Ovarian Sarcoma, Ovarian Stromal Cancer, Recurrent Cervical Cancer, Recurrent Endometrial Carcinoma, Recurrent Ovarian Epithelial Cancer
- Being tested
- stereotactic radiosurgery, quality-of-life assessment
- Medical subject headings
- Fallopian Tube Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Carcinoma, Ovarian Epithelial, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiosurgeryRadiation
Radiation will be delivered in 3 fractions. The dose level will range between 500 to 800cGy per fraction at the discretion of the treating radiation oncologist
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I: CyberKnife Radiosurgery | Experimental | Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. Receives: Radiation: stereotactic radiosurgery; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Toxicity Rate
The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
Measured: at 6 months after treatment
Secondary outcomes (4)
Disease-free Survival
Median disease free survival
Measured: completion of study at 24 months
Median Overall Survival
Length of time patients survived at study end.
Measured: 24 months
Quality of Life
Measured: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Clinical Response Rate
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).
Measured: at 6 months from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert DeBernardo, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079832
- Sponsor's protocol ID
- CASE13808
- Other IDs
- NCI-2010-00285, CASE13808
- Status last verified
- Sep 2013
- First submitted
- 2 Mar 2010
- Last updated
- 28 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT01079832
- Acronym / sponsor ID
- CASE13808
- Conditions
- Fallopian Tube Cancer, Ovarian Sarcoma, Ovarian Stromal Cancer, Recurrent Cervical Cancer, Recurrent Endometrial Carcinoma, Recurrent Ovarian Epithelial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Posted 28 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in treating women with advanced or recurrent gynecological malignancies.
Detailed description
PRIMARY OBJECTIVES:
- The primary goal of this study is to estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period following CyberKnife radiosurgery for gynecologic cancers.
II. To evaluate clinical response to radio-surgery for gynecologic tumors.
III. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O, FACT-Cx or FACT-V) and to evaluate patient's level of pain.
SECONDARY OBJECTIVES:
- As a secondary objective, toxicities during the 2 years following CyberKnife radiosurgery will also be described.
OUTLINE:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I: CyberKnife Radiosurgery | Experimental | Radiation: stereotactic radiosurgery, Procedure: quality-of-life assessmentPatients undergo 3 fractions of CyberKnife stereotactic radiosurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically proven gynecologic malignancy
- No prior cryosurgery or radiofrequency ablation, in target lesion
- Patient is able to give and sign study specific informed consent
- Measurable disease, according to RECIST criteria
- Laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include CBC, basic metabolic panel, BUN, and creatinine
Key exclusion criteria (3 listed)
- Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded
- Any patient with active Crohn's disease or active ulcerative colitis is excluded
- Major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic radiosurgeryRadiation will be delivered in 3 fractions. The dose level will range between 500 to 800cGy per fraction at the discretion of the treating radiation oncologist | Radiation | Arm I: CyberKnife Radiosurgery |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I: CyberKnife Radiosurgery |
Primary outcome
Acute Toxicity Rate
Time frame: at 6 months after treatment
The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
4 secondary outcomes
Disease-free Survival
Time frame: completion of study at 24 months
Median Overall Survival
Time frame: 24 months
Quality of Life
Time frame: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Clinical Response Rate
Time frame: at 6 months from study entry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert DeBernardo, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic radiosurgery and quality-of-life assessment in people with Fallopian Tube Cancer and Ovarian Sarcoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Toxicity Rate (time frame: at 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.