Pro-GRID Therapy for Advanced Cancer

(ProGRID Trial)

Not currently recruiting at 1 trial location

Overseen By Jean Wright, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Age < 18, ECOG 3-4, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new radiation treatment called Pro-GRID, which uses a special technique to target large, tough-to-treat tumors. The researchers aim to assess the safety of this treatment, its potential side effects, and its effectiveness in shrinking tumors. The trial is open to adults with invasive cancer who have tumors larger than 7 cm and seek symptom relief rather than a cure. Participants must be able to perform daily activities without severe restrictions. This approach delivers high doses of radiation in a pattern that affects different parts of the tumor differently. As an unphased trial, it offers patients access to innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this proton pencil beam scanning (PBS GRID) treatment is safe for patients with bulky tumors?

Research has shown that spatially fractionated radiotherapy (SFRT), such as the Pro-GRID treatment, is generally safe. An early review examined patient tolerance to this radiation treatment. Ten patients received the Pro-GRID method, a type of SFRT. The results indicated that the treatment was feasible and safe, with no serious side effects.

Another study examined patients with large tumors treated with a similar method, grid-RT. It also found that the treatment was well-tolerated, with patients reporting no major problems during treatment, suggesting it is manageable.

These studies suggest that Pro-GRID is likely safe for patients. It uses high-dose radiation but targets only small parts of the tumor, which appears to lower the risk of severe side effects. As always, discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pro-GRID therapy is unique because it utilizes spatially-fractionated radiotherapy, delivering a one-time high dose of radiation to small parts of a tumor, creating alternating regions of high and low dose radiation. This method contrasts with conventional radiation therapy, which typically involves uniform radiation doses over multiple sessions. Researchers are excited about Pro-GRID because this approach may potentially target tumors more effectively and minimize damage to surrounding healthy tissue, potentially leading to fewer side effects and improved outcomes for patients with advanced cancer.

What evidence suggests that Pro-GRID might be an effective treatment for advanced cancer?

Research has shown that Pro-GRID therapy, which participants in this trial will receive, offers promising results for treating large tumors. Studies have found that 81.8% of patients experienced some tumor shrinkage. In some cases, patients saw a significant reduction in tumor size and even long-term control. Additionally, patients reported high levels of symptom relief, such as reduced pain. These findings suggest that Pro-GRID could effectively manage hard-to-treat tumors. ^{1 3 6 7 8}

Who Is on the Research Team?

Jean Wright, MD

Principal Investigator

Radiation Oncology, SOM

Are You a Good Fit for This Trial?

This trial is for adults over 18 with large tumors (over 7 cm) like sarcoma or melanoma, who need palliative care to relieve symptoms. They should be fairly active (ECOG status <2), able to consent, and have discussed treatment with a specialist. It's not for those under 18, very ill patients (ECOG status 3-4), pregnant women, or if the tumor wraps around vital parts.

Inclusion Criteria

Willing and able to provide informed consent

You need to talk to a cancer doctor or a surgeon.

I have had radiation therapy and can provide the necessary images if needed.

Exclusion Criteria

For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women

I spend most of my day in bed or sitting due to my health.

My treatment is aimed at completely curing my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time high dose radiation treatment using proton pencil beam scanning GRID therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits at 1, 6, and 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Pro-GRID

Trial Overview The study tests Proton Pencil Beam Scanning GRID (Pro-GRID) therapy on bulky tumors. This phase I trial aims to see how safe it is and how well it works in shrinking these hard-to-treat tumors. All participants will receive this novel treatment without comparison to another group.

How Is the Trial Designed?

Group I: Pro-GRID treatment Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Citations

1. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00144-7/fulltext

Interim Analysis of Pro-Grid: A Phase 1 Proton Spatially ... Spatial fractionation (SFRT) is a radiation therapy technique that targets bulky tumors by delivering alternating high and low doses within the tumor.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12055688/

Progress of the application of spatially fractionated radiation ... SFRT has shown high symptom remission rates, significant target volume reduction, and even tumor control and long-term survival in some cases ...

3. redjournal.org redjournal.org/article/S0360-3016(25)06150-4/abstract

Grid Spatially Fractionated Radiation Therapy for Bulky ... Grid-RT appears to be an effective treatment for bulky tumors, either standalone or as a boost to palliative or definitive radiation. Grid block ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625061504

Grid Spatially Fractionated Radiation Therapy for Bulky ... They reported a tumor response rate of 81.8%, median PFS of 3.8 months, and median OS of 6.2 months. The “quadshot” regimen, reported by Corry ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6872856/

Spatially fractionated radiation therapy: History, present and ... Another study of 71 patients with bulky tumors (size > 8 cm) of varying histologies demonstrated a 78% response in pain improvement, a 59% partial response (PR) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512144/

Spatially fractionated radiotherapy for re-irradiation SFRT is a safe, feasible, and effective technique for re-irradiation. Patients were re-treated with 66.7 Gy in 5 fractions to a high-dose ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11364051/

Spatially fractionated radiotherapy (Lattice SFRT) in the ... This study aims to report the safety and outcomes in patients undergoing Lattice spatially fractionated radiotherapy (Lattice SFRT) for locally advanced bulky ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06980259

Spatially Fractionated Radiotherapy Versus Conventional ... This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated ...