Proton Radiation for Chordomas and Chondrosarcomas

Chondrosarcomas Clinical Trial

Official title:

Proton Radiation For Chordomas and Chondrosarcomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01449149
• Other study ID #: UPCC 01310
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2010
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This trial will be conducted in two phases: a feasibility then a phase II trial. Once feasibility and safety are established in the first 12 pts. the phase II study will begin. Proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chondrosarcoma
• Chondrosarcomas
• Chordoma
• Chordomas

Intervention

Radiation:
• Proton Therapy

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of proton RT for chordomas and chondrosarcomas	Treatment completion	Up to 10 days
Primary	Acute Toxicity	Any grade 3 or higher toxicity observed within 90 days from start of therapy.	90 days
Secondary	Late toxicity	Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.	90 days