Clinical trial · Interventional
Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial
NCT02575027CI-TRIAL-00037354completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Recurrent Brain Neoplasm | Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative Radiation Therapy | Radiation | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radiation Therapy Treatment Planning and Simulation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (4pi radiotherapy)
- description
- Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.
- interventionNames
- Radiation: Palliative Radiation Therapy
- Other: Questionnaire Administration
- Radiation: Radiation Therapy Treatment Planning and Simulation
Primary outcomes (3)
- measure
- Accuracy of dose delivery
- timeFrame
- Up to 6 weeks
- description
- The accuracy of dose delivery by 4pi will be compared to standard procedures. Standard quality assurance (QA) procedures will be employed to validate the delivery accuracy of 4pi. Specifically, a MatriXX phantom will be employed to measure the dose in both the coronal and sagittal planes and compared to calculation. Patients with QA results showing gamma passing rates (using 3% and 3 mm dose difference and distance to agreement criteria, respectively) less than 90% in either plane or a maximum single gamma value greater than 2 will not be treated until the source of error is corrected.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary glioblastoma multiforme (GBM) * Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide) * Patient must be diagnosed with recurrent GBM either with biopsy or radiographically * Karnofsky Performance Status (KPS) \>= 70 * Ability to understand and willingness to sign a written informed consent * If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment * For the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least 1 year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation) Exclusion Criteria: * Patients with active infection * Patients with KPS \< 70 and/or unable to tolerate potentially longer treatment times * Refusal to sign informed consent * Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment * Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible
References
Publications (0)
Data not yet available
No reference posted for this study.