Clinical trial · Interventional
Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
NCT01494012CI-TRIAL-00027264terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of Peritoneum | — | UNRESOLVED | — |
| Recurrent Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 | Drug | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT)
- description
- Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: stereotactic body radiation therapy
- Procedure: positron emission tomography
- Procedure: computed tomography
- Other: questionnaire administration
- Drug: fludeoxyglucose F 18
Primary outcomes (2)
- measure
- Tumor response to SBRT as assessed by FDG-PET/CT
- timeFrame
- At 3 months
- description
- FDG-PET response based on interpretation by nuclear medicine physician with measurement of the maximal standard uptake value (SUV) and identification of new sites of disease. Percentage of decreased SUVmax between the pre- and post-treatment FDG-PET/CT, evaluating means, medians, range and standard deviations.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have persistent, metastatic, or recurrent platinum resistant or refractory ovarian or primary peritoneal cancer. * No restriction on previous treatment regimens, but patients must be at least 2 weeks out from last chemotherapy or investigational agent. * Patients must be \>= 18. * Patients must have a life expectancy of at least 6 months. * Patients must have KPS \>= 60. * Patients must have acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy): * leukocytes \>=3,000/uL * absolute neutrophil count \>=1,500uL * platelets \>=100,000/uL * total bilirubin within 1.5X normal institutional limits * AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR * creatinine clearance \>=60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Patients must be willing to undergo a pre- and post-treatment FDG-PET/CT. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients should not have received radiation overlapping with the proposed treatment field. * Patients cannot be receiving chemotherapy or other investigation agents from two weeks prior to radiation through undergoing their post-therapy FDG-PET/CT * Patients cannot be pregnant or nursing. * Patients cannot have disease \>= 8cm or greater than 3 regions of disease. * Patients cannot have concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix.
References
Publications (0)
Data not yet available
No reference posted for this study.