SarcomaProGRIDNCT05121545
Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors
A study testing Pro-GRID in people with Sarcoma and Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Pro-GRID
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age > 18
- Histologically or cytologically confirmed invasive cancer
- Bulky tumor > 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
- Treated indicated for palliative intent
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Anticipated treatment deemed safe on pre-review by PI
Show all 9Show fewer
- For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID
- Willing and able to provide informed consent
- Discussion with medical oncology or surgical specialty
Who cannot join
- Age < 18
- ECOG performance status 3-4
- Planned for definitive, curative management
- For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
- Tumor encasing critical structure, as defined by the treating MD.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)
This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.
Read the detailed description
The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques.
In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern.
In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.
- Being tested
- Pro-GRID
- Keywords
- Spatially-fractionated radiotherapy, GRID-therapy, Proton therapy, Sarcoma, Melanoma, Treatment resistant tumors
- Medical subject headings
- Sarcoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-GRIDRadiation
Also called Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRID
Study participants will receive a single treatment of Pro-GRID therapy. After which, the participants would be able to resume standard therapy (after one week) and receive additional radiotherapy one month after Pro-GRID therapy, if recommended. Participants will be in the study for one year. Follow-up appointments will be scheduled at 1, 3, 6 and 12 months posttreatment, and may include a history and physical exam, labs and/or a CT scan and toxicity assessments.
| Study group | Role | What they receive |
|---|---|---|
| Pro-GRID treatment Arm | Other | Patients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction. Receives: Radiation: Pro-GRID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants
To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.
Measured: 1.5 years
Secondary outcomes (3)
Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
To determine the rate of mild acute toxicity, defined as any CTCAE grade 2 or lower toxicity, and severe acute toxicity, defined as any CTCAE grade 3 or higher toxicity.
Measured: 3 months post-treatment
Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy
To determine the change in response rate for bulky tumors treated and not treated with Proton GRID by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
Measured: 1, 6 and 12 months post-treatment
Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy
Change in degree of treatment response would be measured by RECIST criteria (partial response, complete response, stable disease, or progression of disease).
Measured: 1, 6 and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start6 Apr 2022
- Primary completion24 Sep 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm phase I study design, evaluating the feasibility (primary endpoint), toxicity (secondary endpoint), and degree of response (exploratory endpoint) after proton GRID therapy in patients with bulky tumors.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Wright, MD, Principal investigator, Radiation Oncology, SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121545
- Sponsor's protocol ID
- J2161
- Other IDs
- IRB00289810
- Acronym
- ProGRID
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2021
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)
- ClinicalTrials.gov ID
- NCT05121545
- Acronym / sponsor ID
- ProGRID / J2161
- Keywords
- Spatially-fractionated radiotherapy, GRID-therapy, Proton therapy, Sarcoma, Melanoma, Treatment resistant tumors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Nov 2021 (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.
This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.
Detailed description
The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques.
In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern.
In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm phase I study design, evaluating the feasibility (primary endpoint), toxicity (secondary endpoint), and degree of response (exploratory endpoint) after proton GRID therapy in patients with bulky tumors.
| Arm | Type | Receives |
|---|---|---|
| Pro-GRID treatment Arm | Other | Radiation: Pro-GRIDPatients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18
- Histologically or cytologically confirmed invasive cancer
- Bulky tumor > 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
- Treated indicated for palliative intent
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
Key exclusion criteria (5 listed)
- Age < 18
- ECOG performance status 3-4
- Planned for definitive, curative management
- For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
- Tumor encasing critical structure, as defined by the treating MD.
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 |
|---|---|---|
| Pro-GRIDAlso: Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRIDStudy participants will receive a single treatment of Pro-GRID therapy. After which, the participants would be able to resume standard therapy (after one week) and receive additional radiotherapy one month after Pro-GRID therapy, if recommended. Participants will be in the study for one year. Follow-up appointments will be scheduled at 1, 3, 6 and 12 months posttreatment, and may include a history and physical exam, labs and/or a CT scan and toxicity assessments. | Radiation | Pro-GRID treatment Arm |
Primary outcome
Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants
Time frame: 1.5 years
To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.
3 secondary outcomes
Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
Time frame: 3 months post-treatment
Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy
Time frame: 1, 6 and 12 months post-treatment
Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy
Time frame: 1, 6 and 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- 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.
Jean Wright, MD principal investigator
Radiation Oncology, SOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro-GRID in people with Sarcoma and Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants (time frame: 1.5 years). 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 29 Jan 2026.