Trial · NCT00003590
S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
NCT00003590, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2012-02-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma. Trials, record NCT00003590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003590
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
- NCT number
- NCT00003590
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Adult Meningioma
- Interventions
- hydroxyurea
- First posted
- 2003-01-27
- Last updated
- 2016-05-20
- Results first posted
- 2012-02-16
- Limitations and caveats
- Early termination leading to fewer than expected subjects analyzed. With 28 eligible patients estimate of response probability can be estimated to within +/- 19%.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Patients treated for 2 years or progression. If responding can continue at physician's discretion. | Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed). |
| Secondary | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months | Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Patients treated for 2 years or progression. If responding can continue at physician's discretion. | All eligible patients who started treatment were included in assessing response estimates. | Participants | NUMBER |
| SECONDARY | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months | Eligible patients who had received any hydroxyurea were included in the adverse event summaries. Any CTC 2.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. | Participants with a given type of AE | NUMBER |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Hydroxyurea | Complete Response (CR) | 0 | Participants | |
| Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Hydroxyurea | Confirmed Partial Response (PR) | 0 | Participants | |
| Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Hydroxyurea | Unconfirmed Complete Response (UCR) | 0 | Participants | |
| Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Hydroxyurea | Unconfirmed Partial Response (UPR) | 0 | Participants | |
| Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Hydroxyurea | No Response | 28 | Participants | |
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Hydroxyurea | Anemia | 1 | Participants with a given type of AE | |
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Hydroxyurea | Confusion | 1 | Participants with a given type of AE | |
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Hydroxyurea | Dyspnea | 1 | Participants with a given type of AE | |
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Hydroxyurea | Fatigue/malaise/lethargy | 1 | Participants with a given type of AE | |
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Hydroxyurea | Headache | 2 | Participants with a given type of AE |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydroxyurea | 29 | |
| Overall Study | Eligible | Hydroxyurea | 28 | |
| Overall Study | Eligible and Began Protocol Therapy | Hydroxyurea | 28 | |
| Overall Study | COMPLETED | Hydroxyurea | 7 | |
| Overall Study | NOT COMPLETED | Hydroxyurea | 22 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Hydroxyurea | 3 | 28 | |
| other | Constipation/bowel obstruction | Gastrointestinal disorders | Hydroxyurea | 3 | 28 | |
| other | Diarrhea without colostomy | Gastrointestinal disorders | Hydroxyurea | 6 | 28 | |
| other | Dyspepsia/heartburn | Gastrointestinal disorders | Hydroxyurea | 3 | 28 | |
| other | Nausea | Gastrointestinal disorders | Hydroxyurea | 12 | 28 | |
| other | Stomatitis/pharyngitis | Gastrointestinal disorders | Hydroxyurea | 3 | 28 | |
| other | Edema | General disorders | Hydroxyurea | 8 | 28 | |
| other | Fatigue/malaise/lethargy | General disorders | Hydroxyurea | 15 | 28 | |
| other | Pain-other | General disorders | Hydroxyurea | 5 | 28 | |
| other | Infection w/o 3-4 neutropenia | Infections and infestations | Hydroxyurea | 2 | 28 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydroxyurea | ||
| Total, other adverse events | Hydroxyurea | 28 | 28 |
| Total, serious adverse events | Hydroxyurea | 0 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00003590
GET https://conductscience.org/api/trials/v1/NCT00003590/events?page=2