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Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS (PROTONS-RPS)

Primary Purpose

Retroperitoneal Sarcoma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hypofractionated Proton Beam Therapy

About this trial

This is an interventional treatment trial for Retroperitoneal Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sibley Memorial Hospital
Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated Proton Beam Therapy

Arm Description

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)).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Safety determined by incidence of acute Grade 3+ adverse events per the NCI CTCAE v5.0 in patients on treatment with H-PBT prior to surgical resection.

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

Lack of tolerability determined by cessation of NA H-PBT due to toxicity or required dose reduction for serious adverse events (NCI CTCAE v5.0).

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

Local or distant tumor progression based on RECIST 1.1 criteria on pre-operative contrast-enhanced CT scan of the chest, abdomen, and pelvic compared to staging CT.

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

Incidence of 30-day (acute) post-operative complications based on Clavien-Dindo classification.

Local recurrence-free survival (LRFS)

Time from study enrollment to the earliest of local recurrence, death, or loss to follow-up after NA short-course h-PBT and resection. Recurrence will be determined on CT of the thorax, abdomen, and pelvis at 6-month intervals for 2 years.

Full Information

NCT ID

NCT05302570

First Posted

March 21, 2022

Last Updated

December 13, 2022

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Robert L. Sloan Fund for Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT05302570

Brief Title

Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS

Acronym

PROTONS-RPS

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Withdrawn

Why Stopped

withdrawn by PI

Study Start Date

December 2022 (Anticipated)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Robert L. Sloan Fund for Cancer Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retroperitoneal Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated Proton Beam Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated Proton Beam Therapy

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

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

Description

Safety determined by incidence of acute Grade 3+ adverse events per the NCI CTCAE v5.0 in patients on treatment with H-PBT prior to surgical resection.

Time Frame

Up to 6 weeks

Title

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

Description

Lack of tolerability determined by cessation of NA H-PBT due to toxicity or required dose reduction for serious adverse events (NCI CTCAE v5.0).

Time Frame

Up to 6 weeks

Title

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

Description

Local or distant tumor progression based on RECIST 1.1 criteria on pre-operative contrast-enhanced CT scan of the chest, abdomen, and pelvic compared to staging CT.

Time Frame

Up to 6 weeks (pre-operatively)

Title

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

Description

Incidence of 30-day (acute) post-operative complications based on Clavien-Dindo classification.

Time Frame

30 days after surgery

Title

Local recurrence-free survival (LRFS)

Description

Time Frame

Every 6 months, Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amol Narang, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sibley Memorial Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20018

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS

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