Chordoma of Sacrum Clinical Trial
Official title:
Phase II Study of High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
There are two types of external radiation treatments; proton beam and photon beam radiation. What type of therapy participants will receive will depend upon the location of their tumor. Standard treatment would involve receiving either proton or photon radiation delivered by a three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a technique where the beams of radiation used in the treatment are shaped to match the tumor in order to avoid damaging the healthy surrounding tissue. Standard treatment also may include photon radiation delivered by intensity modulated (IMRT) technique. In this research study we are using an investigational technique to deliver proton radiation therapy called intensity modulated proton radiation treatment (IMPT) which is used to target cancer while sparing healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned down during the treatment. This control over the intensity of the radiation dose has the potential to provide accuracy and allows us to more safely increase the amount of radiation delivered to the tumor. This accuracy may potentially reduce side effects that patients would normally experience with 3-D proton radiation therapy. Surgery is often an important component of the treatment for these tumors and may be integrated with the IMPT.
- Before beginning radiation therapy, the participants will have a radiation planning
computed tomographic (CT) scan of the tumor site. This is considered standard of care
and the doctor will use the images from this scan to plan the radiation treatment.
- Participants may also receive surgery either before or after the study radiation
treatment. This surgery is also considered standard of care and would be done regardless
of being in the research study.
- The IMPT technique for delivering radiation is for research purposes only. Radiation
treatment to the affected tumor will be given daily, Monday through Friday.
- The following procedures will be performed once a week during treatment: assessment of
nerve, neuromuscular, motor and sensory function by clinical exam and toxicity
assessment.
- Participants will return for follow-up visits after completion of the radiation
treatment at the following intervals: 6 weeks after completion of treatment, 6 months
after treatment, every 6 months thereafter for 4 years, and then each year after for up
to 15 years.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03058289 -
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
|
Phase 1/Phase 2 |