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Proton Beam Therapy

Pro-GRID Therapy for Advanced Cancer (ProGRID Trial)

N/A

Recruiting

Led By Jean Wright, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treated indicated for palliative intent

Age > 18

Must not have

ECOG performance status 3-4

Planned for definitive, curative management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses proton pencil beam scanning. They are testing how well it works and how safe it is.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed but may include typical reactions associated with radiation therapies such as skin irritation at the treatment site, fatigue, nausea, and potential damage to nearby organs depending on tumor location.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving treatment to ease symptoms, not to cure my disease.

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I am older than 18 years.

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My tumor is larger than 7 cm.

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I can do all my daily activities without help.

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My cancer was confirmed through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My treatment is aimed at completely curing my condition.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interventional procedure

Secondary study objectives

Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy

Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy

Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pro-GRID treatment ArmExperimental Treatment1 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.

0 / 8Eligibility criteria met