Soft Tissue Sarcoma of the Extremities Clinical Trial
Official title:
Proton Radiotherapy for Extremity Soft Tissue Sarcoma
Verified date | November 2019 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study of proton radiotherapy for the pre- or post- operative treatment of patients
with extremity sarcoma. This study will treat patients in two dose groups:
1. patients receiving pre-operative proton therapy and
2. patients receiving post-operative proton therapy. In each dose group, the study is
divided into two phases. In the first phase of the study, the investigators will
determine if treatment with proton therapy is safe and can be delivered on a regular
basis. In the second phase, the investigators will determine if proton therapy has less
long term side effects compared to standard radiation in both pre-operative patients and
post-operative patients.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 3, 2017 |
Est. primary completion date | February 3, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a histologic diagnosis of soft tissue sarcoma of the extremities are eligible for this study. - Patient must be 18 years of age. - Patients must have evidence of disease limited to the extremities. - For the pre-operative group, patients must be considered operable/resectable and a candidate for pre-operative radiotherapy as judged by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. All patients in the pre-operative group will be evaluated for this protocol PRIOR to the initiation of therapy. - For the post-operative group, patients must be considered operable/resectable (if evaluated prior to resection) and a candidate for post-operative radiotherapy by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. Patients in the post-operative group may be evaluated PRIOR to the initiation of any therapy or may be referred for evaluation after surgical resection. - ECOG status of 0-2. - Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable to sign informed consent are excluded from the study. - 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. - Negative urine pregnancy test for females of childbearing potential on the day of the F18-EF5 PET scan prior to F18-EF5 injection Exclusion Criteria: - Pregnant women, women planning to become pregnant and women that are nursing. - Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease. |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Adverse Events | Given this is initially a feasibility study- the primary measure is number of AEs (Adverse Events). | 4 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05978024 -
Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B
|