Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS

NCT ID: NCT05302570

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2027-12-31

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.

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 Events (CTCAE) version 5.0.2 Secondary objectives include evaluating the acute toxicity of H-PBT prior to surgical resection, rate of progression between diagnosis and definitive resection, early post-operative complication rate after resection of RPS in patients who received NA H-PBT, and local recurrence-free survival at 1 and 2 years. A priori subset analyses will be conducted for patients with well-differentiated and dedifferentiated liposarcoma.

The investigators plan to accrue a minimum of 44 patients to evaluate the investigators' primary outcome. Treatment will be 5 doses of H-PBT including a simultaneous integrated boost to at-risk margins followed by surgical resection after 4-6 weeks. Patients will be followed in the post-operative setting according to standard of care surveillance for RPS.

Conditions

Retroperitoneal Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated Proton Beam Therapy

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)).

Group Type: EXPERIMENTAL

Hypofractionated Proton Beam Therapy

Intervention Type: 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)).

Interventions

Hypofractionated Proton Beam Therapy

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)).

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert L. Sloan Fund for Cancer Research

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amol Narang, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sibley Memorial Hospital

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

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00315399

Identifier Type: -

Identifier Source: org_study_id