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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
ProGRID Trial 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.Check my eligibility
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.See study design
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.
ProGRID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ProGRID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interventional procedure
Secondary outcome measures
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)
ProGRID 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.
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,908 Total Patients Enrolled
14 Trials studying Sarcoma
294 Patients Enrolled for Sarcoma
Jean Wright, MDPrincipal InvestigatorRadiation Oncology, SOM
3 Previous Clinical Trials
149 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to talk to a cancer doctor or a surgeon.I have had radiation therapy and can provide the necessary images if needed.I am receiving treatment to ease symptoms, not to cure my disease.I spend most of my day in bed or sitting due to my health.My treatment is aimed at completely curing my condition.I am older than 18 years.My tumor is larger than 7 cm.I can do all my daily activities without help.My tumor is growing around an important body part.I am under 18 years old.My cancer was confirmed through a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Pro-GRID treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are fresh enrollees currently being accepted for this experiment?
"Clinicaltrials.gov indicates that this experiment is still recruiting participants, with the original posting being on April 6th 2022 and an update to the listing made October 11th 2022."
Answered by AI
What is the maximum capacity of individuals in this trial?
"Affirmative. According to records hosted on clinicaltrials.gov, this medical trial is currently searching for suitable candidates and was first advertised on April 6th 2022. It requires 12 patients at a single location for successful completion and the data was last updated on October 11th 2022 ."
Answered by AI
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