Clinical trial · Interventional
Proton Radiation for Chordomas and Chondrosarcomas
Proton Radiation For Chordomas and Chondrosarcomas
NCT01449149CI-TRIAL-00098535completedN/AResults postedClinicalTrials.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)
The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.
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 |
|---|---|---|---|
| Chondrosarcomas | Chondrosarcoma | ALIAS | 0.90 |
| Chordomas | Chordoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton group
- description
- Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
- interventionNames
- Radiation: Proton Therapy
Primary outcomes (1)
- measure
- Feasibility of Proton RT for Chordomas and Chondrosarcomas
- timeFrame
- From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months
- description
- The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and chondrosarcomas of the skull base and spine. The feasibility, as defined by ≥10% of patients experiencing either: unsatisfactory dosimetry, inability to complete all of his/her treatments within 10 days of estimated completion date and requiring no break \>5 days, and no greater than 20% of patients experiencing ≥grade 3 toxicity from RT.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of chordoma or chondrosarcoma. * Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.) * Patients must have an ECOG score equal to or less than 2. * Age ≥ 18 years. * Patients must be able to provide informed consent. * Adequate bone marrow function: WBC ≥ 4000/mm3, platelets ≥ 100, 000mm3 * Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive , IUD, condoms or other barrier methods etc.) Hysterectomy or menopause must be clinically documented. * Tumors arising in the skull and spine. Exclusion Criteria: * Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies. * Pregnant women. * Actively being treated on any other therapeutic research study. * Tumors arising outside of the CNS.
References
Publications (0)
Data not yet available
No reference posted for this study.