WithdrawnPhase 2
Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS
Key facts
- Who runs it
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Where
- Baltimore and Washington D.C., United StatesSee the 2 sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- Dec 2022
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- Hypofractionated Proton Beam Therapy
- Record updated
- 15 December 2022
- Why it stopped
- withdrawn by PI
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Evidence of metastatic disease on staging CT of chest/abdomen/pelvis
- History of abdominal or pelvic radiation therapy
- History of systemic lupus erythematosus or ulcerative colitis
- Genetic syndrome with radiation-associated tumorigenicity (i.e.: Li-Fraumeni)
- 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
- 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
- Presence of clinically significant ascites
Where in United States
- Johns Hopkins HospitalBaltimore, United StatesNo longer taking part
- Sibley Memorial HospitalWashington D.C., United StatesNo longer taking part
About the trial
What the trial wants to find out
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 Sarcoma" is a phase II trial evaluating the safety and efficacy of hypofractionated proton beam therapy (H-PBT) in the neoadjuvant (NA) setting for patients with non-metastatic retroperitoneal sarcoma (RPS) planned for surgical resection. This trial will include adult patients with resectable RPS.
The group in the trial
- Hypofractionated Proton Beam TherapyTreatment being tested
5 fractions of 5 Gy of PBT to clinical tumor volume +/- an additional simultaneous 1 Gy per fraction to any pre-determined at-risk margin (for a total of 6 Gy per fraction x 5 fractions for at-risk margins as a simultaneous integrated boost (SIB)).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PROTONS-RPS: a Phase II Non-Randomized Open-label Single-arm Trial Of Neoadjuvant Short-course Hypofractionated Proton Beam Therapy for Non-metastatic RetroPeritoneal Sarcoma
- Record updated
- 15 December 2022