Retroperitoneal SarcomaPhase 2PROTONS-RPSNCT05302570
Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS
A Phase 2 study testing Hypofractionated Proton Beam Therapy in people with Retroperitoneal Sarcoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Sarcoma
- What is being tested?
- Hypofractionated Proton Beam Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2022to Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20018
About this study
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
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.
Read the 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
- Being tested
- Hypofractionated Proton Beam Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Proton Beam TherapyRadiation
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)).
| Study group | Role | What they receive |
|---|---|---|
| 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)). Receives: Radiation: Hypofractionated Proton Beam Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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).
Measured: Up to 6 weeks
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.
Measured: Up to 6 weeks (pre-operatively)
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.
Measured: 30 days after surgery
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.
Measured: Every 6 months, Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: withdrawn by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal SarcomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Amol Narang, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302570
- Sponsor's protocol ID
- IRB00315399
- Acronym
- PROTONS-RPS
- Status last verified
- Dec 2022
- First submitted
- 21 Mar 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05302570
- Acronym / sponsor ID
- PROTONS-RPS / IRB00315399
- Conditions
- Retroperitoneal Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Proton Beam Therapy | Experimental | Radiation: Hypofractionated Proton Beam Therapy5 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)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Proton Beam Therapy5 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 |
Primary outcome
Overall serious adverse event rate for patients with primary resectable RPS receiving NA short-course h-PBT followed by surgical resection
Time frame: 24 months
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.
5 secondary outcomes
Safety of NA short-course hypofractionated PBT for primary resectable RPS as assessed by incidence of acute Grade 3+ adverse events
Time frame: 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
Time frame: Up to 6 weeks
Rate of local or distant tumor progression from diagnosis to time of surgery after treatment with PBT
Time frame: Up to 6 weeks (pre-operatively)
Rate of acute post-operative surgical complications in patients receiving NA short-course hypofractionated PBT
Time frame: 30 days after surgery
Local recurrence-free survival (LRFS)
Time frame: Every 6 months, Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Narang, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated Proton Beam Therapy in people with Retroperitoneal Sarcoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall serious adverse event rate for patients with primary resectable RPS receiving NA short-course h-PBT followed by surgical resection (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.