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Proton Radiation for Chordomas and Chondrosarcomas

Primary Purpose

Chordomas, Chondrosarcomas

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Therapy
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chordomas focused on measuring Age 18 or greater, No prior radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton group

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility of proton RT for chordomas and chondrosarcomas
Treatment completion
Acute Toxicity
Any grade 3 or higher toxicity observed within 90 days from start of therapy.

Secondary Outcome Measures

Late toxicity
Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.

Full Information

First Posted
October 4, 2011
Last Updated
June 21, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01449149
Brief Title
Proton Radiation for Chordomas and Chondrosarcomas
Official Title
Proton Radiation For Chordomas and Chondrosarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2010 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chordomas, Chondrosarcomas
Keywords
Age 18 or greater, No prior radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proton group
Arm Type
Experimental
Arm Description
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Intervention Type
Radiation
Intervention Name(s)
Proton Therapy
Primary Outcome Measure Information:
Title
Feasibility of proton RT for chordomas and chondrosarcomas
Description
Treatment completion
Time Frame
Up to 10 days
Title
Acute Toxicity
Description
Any grade 3 or higher toxicity observed within 90 days from start of therapy.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Late toxicity
Description
Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Proton Radiation for Chordomas and Chondrosarcomas

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