Status:
WITHDRAWN
Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Robert L. Sloan Fund for Cancer Research
Conditions:
Retroperitoneal Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators' study titled "PROTONS-RPS: a Phase II non-Randomized Open-label single-arm Trial Of Neoadjuvant Short-course hypofractionated proton beam therapy for non-metastatic RetroPeritoneal ...
Detailed Description
The investigators' primary outcome is overall complication rate after treatment with NA H-PBT and surgical resection based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Ev...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years of age)
- Patients with primary non-recurrent retroperitoneal sarcoma
- Calculated creatinine clearance ≥50 mL/min and functional contralateral kidney based on nuclear medicine renal scan
- Normal bone marrow function (WBC ≥ 4 x109 /L)
- Eastern Cooperative Oncology Group status ≤ 2
- Cardiac function ≤ New York Heart Association class II
- Proton beam therapy approved by insurance (including Medicare/Medicaid)
Exclusion
- Evidence of metastatic disease on staging CT of chest/abdomen/pelvis
- History of abdominal or pelvic radiation therapy
- Inability to tolerate supine position for duration of PBT simulation or treatment
- Tumor originating from gastrointestinal or gynecologic organs
- Specific sarcoma histologies including osteosarcoma, desmoid tumors, chondrosarcoma arising from vertebrae or pelvic bones, embryonal rhabdomyosarcoma
- Tumor extending into femoral or obturator canal
- History of systemic lupus erythematosus or ulcerative colitis
- Genetic syndrome with radiation-associated tumorigenicity (i.e.: Li-Fraumeni)
- Presence of clinically significant ascites
- Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05302570
Start Date
December 1 2022
End Date
December 1 2027
Last Update
December 15 2022
Active Locations (2)
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1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20018
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287