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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Withdrawn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withdrawn by PI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