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Proton Radiation For Chordomas and Chondrosarcomas


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chordomas, Chondrosarcomas

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Trial Information

Proton Radiation For Chordomas and Chondrosarcomas


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.


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Feasibility

Outcome Description:

patient is unable to complete all of his/her treatments with 10 days of estimated date of treatment completion or requires a treatment breaks greater than 5 days.

Outcome Time Frame:

Up to 10 days

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UPCC 01310

NCT ID:

NCT01449149

Start Date:

March 2010

Completion Date:

March 2014

Related Keywords:

  • Chordomas
  • Chondrosarcomas
  • Age 18 or greater
  • No prior radiation
  • Chondrosarcoma
  • Chordoma

Name

Location

Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283