Proton Radiation for Chordomas and Chondrosarcomas

NCT01449149 | Completed Results DMC

• 1 other identifier: UPCC 01310
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chordomas; Chondrosarcomas

Keywords

Age 18 or greater; No prior radiation

Outcome Measures

Primary Outcomes (1)

• Feasibility of Proton RT for Chordomas and Chondrosarcomas

  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.

  From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months

Secondary Outcomes (2)

• Acute Toxicities

  With in the 90 days from tx start date

• Late Toxicities

  Every 3 months for 3 Years from the tx start date and assessed up to 133 months

Study Arms (1)

Proton group

EXPERIMENTAL

Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions

Radiation: Proton Therapy

Interventions

Proton Therapy RADIATION

Proton group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Chordoma; Chondrosarcoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Michelle Alonso-Basanta, MD PhD
• Organization: Department of Radiation Oncology, PENN MEDICINE

michelleab@uphs.upenn.edu

215 615 3782

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 10, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2025
• Study Completion: September 4, 2025
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-11

Locations

US (1)