Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS

NCT05302570 | Withdrawn Phase 2

• 1 other identifier: IRB00315399
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Retroperitoneal Sarcoma

Outcome Measures

Primary Outcomes (1)

• Overall serious adverse event rate for patients with primary resectable RPS receiving NA short-course h-PBT followed by surgical resection

  Incidence of acute Grade 3+ adverse events after PBT and surgical resection during median follow-up based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  24 months

Secondary Outcomes (5)

• Safety of NA short-course hypofractionated PBT for primary resectable RPS as assessed by incidence of acute Grade 3+ adverse events

  Up to 6 weeks

• Tolerability of NA short-course hypofractionated PBT for primary resectable RPS as assessed by cessation of NA H-PBT due to toxicity or required dose reduction for serious adverse events

  Up to 6 weeks

• Rate of local or distant tumor progression from diagnosis to time of surgery after treatment with PBT

  Up to 6 weeks (pre-operatively)

• Rate of acute post-operative surgical complications in patients receiving NA short-course hypofractionated PBT

  30 days after surgery

• Local recurrence-free survival (LRFS)

  Every 6 months, Up to 2 years

Study Arms (1)

Hypofractionated Proton Beam Therapy

EXPERIMENTAL

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)).

Radiation: Hypofractionated Proton Beam Therapy

Interventions

Hypofractionated Proton Beam Therapy RADIATION

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)).

Hypofractionated Proton Beam Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Robert L. Sloan Fund for Cancer Research: collaborator

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20018, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Amol Narang, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)