Clinical trial · Interventional
Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
- 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 primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.
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 |
|---|---|---|---|
| Chondrosarcoma | Chondrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Chordoma | Chordoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Charged Particle Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- 40-44 Treatments
- interventionNames
- Radiation: Charged Particle Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Group 2
- description
- 37-40 Treatments
- interventionNames
- Radiation: Charged Particle Radiation Therapy
Primary outcomes (1)
- measure
- Acute Toxicity
- timeFrame
- 90 days
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist * Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine * Boost target volume less than or equal to 150 * 18 years of age or older * Karnofsky Performance Status \> 50 * Neurologic Function of I or II * No evidence of metastases Exclusion Criteria: * Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment * Concurrent or prior malignancy unless disease free for 5 or more years * Evidence of metastatic disease * Diabetes mellitus * Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy
References
Publications (1)
- DERIVEDIoakeim-Ioannidou M, Yeap BY, Soetan ZO, Kim DW, Packard D, Hegazy R, Todary ES, Tejada A, Adams J, Kooy H, Zieminski S, Depauw N, Nielsen GP, Hung YP, Rosenberg A, Tobert DG, Shankar G, Curry WT, Cote GM, Kelly HR, Cunnane ME, Chang YS, Gardner P, Giap F, Chen YL, Delaney TF, Hug E, Liu KX, Shih HA, MacDonald SM. Prospective, randomized dose-escalation trial with proton-based radiation for skull base and cervical spine chondrosarcomas: 30-year outcomes from PROG 85-26. Neuro Oncol. 2026 Apr 1;28(4):968-977. doi: 10.1093/neuonc/noaf289. PMID 41414803