Neoplasm - Soft Tissue Pelvis Malignant SecondaryPhase 1NCT05880667
Adaptive Radiation for Abdominopelvic Metastases
A Phase 1 study testing Adaptive Stereotactic Body Radiation in people with Neoplasm - Soft Tissue Pelvis Malignant Secondary and Malignant Neoplasm of Stomach, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm - Soft Tissue Pelvis Malignant Secondary, Malignant Neoplasm of Stomach
- What is being tested?
- Adaptive Stereotactic Body Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Jun 2029
- Phase
- Phase 1
- 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
- Subjects must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target lesion untreated by radiation, IR techniques, or growing in the abdomen or pelvis. Adjacent lymph nodes in the same region (5 cm or closer) constitute one active lesion. Target lesion must be measurable according to RECIST v 1.1. Previous systemic therapies are allowed.
- Age > 18 years.
- ECOG performance status 0 or 1
- Estimated survival of >/= 12 months
- Subjects must have normal organ and marrow function as defined below
- Absolute neutrophil count > 1,500/mcL
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- Platelets > 100,000/mcL
- Total bilirubin < 2 mg/dL
- AST/ALT (SGOT/SGPT) < 5X ULN
- Creatinine < 1.5X ULN OR
- Creatinine clearance ≥ 50 ml/min/1.73 m2 for subjects with creatinine levels above institutional normal
- Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.
Who cannot join
- Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia and fatigue.
- Subjects must not be receiving any other investigational agents.
- Subjects must not have known peritoneal carcinomatosis visible on imaging.
- Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
- Subjects must not have 6 or more active metastatic sites.
- Subjects must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed.
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- Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).
- Subjects must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Adaptive Radiation for Abdominopelvic Metastases (ARAM)
Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with metastatic cancer to the abdomen or pelvis requiring local control or palliation will be enrolled.
Read the detailed description
This is a dose-escalation study where the objective is to find the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of adaptive SBRT for abdominopelvic SBRT. There are 3 doses of interest 8Gy/fraction (level 1), 9Gy/fraction (level 2), and 10Gy/fraction (level 3). The starting dose will be level 2. We will use a Bayesian Optimal Interval Design (BOIN) to define dose escalation and de-escalation rules based on the proportion of patients experiencing a dose-limiting toxicity (DLT). DLT events are Grade 3 events possibly, probably, or definitely related to the study intervention.
- Being tested
- Adaptive Stereotactic Body Radiation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Stereotactic Body RadiationRadiation
Radiation therapy is given following generation of planning imaging at the time of simulation. A recent development has been diagnostic quality onboard imaging incorporated within radiation treatment machines. The incorporation of onboard imaging into standard practice has allowed the use Stereotactic Body Radiation (SBRT), which is a precise radiation technique that allows safe delivery of ablative radiation doses.
More recently, the development of improved technologies and software have allowed radiation plans to be generated and delivered that are specific to the anatomy of the very moment the patient is being treated. This novel ability to adjust the radiation treatment plan based upon real time imaging is termed adaptive radiation therapy. This study will utilize the novel adaptive radiation therapy technology in a patient population with technically challenging disease to deliver ablative radiation with an appropriately low toxicity rate.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Stereotactic Body Radiation | Experimental | Simulation and treatment to be performed over 3-4 weeks per dose escalation Receives: Radiation: Adaptive Stereotactic Body Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of adaptive SBRT to deliver increased doses of radiation safely to patients with challenging anatomical locations of metastatic disease without causing unacceptable toxicity.
Cohorts of size 10 will be enrolled, Severe (grade 3) toxicity occurring within 3 months of treatment that is possibly, probably, or definitely related to trial therapy will be assessed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Aug 2023
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Why it stopped: Pending interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm - Soft Tissue Pelvis Malignant SecondaryStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880667
- Sponsor's protocol ID
- RT-218
- Other IDs
- 23-1012
- Status last verified
- Oct 2026
- First submitted
- 19 May 2023
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Radiation for Abdominopelvic Metastases (ARAM)
- ClinicalTrials.gov ID
- NCT05880667
- Acronym / sponsor ID
- RT-218
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pending interim analysis
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 30 May 2023 (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.
Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with metastatic cancer to the abdomen or pelvis requiring local control or palliation will be enrolled.
Detailed description
This is a dose-escalation study where the objective is to find the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of adaptive SBRT for abdominopelvic SBRT. There are 3 doses of interest 8Gy/fraction (level 1), 9Gy/fraction (level 2), and 10Gy/fraction (level 3). The starting dose will be level 2. We will use a Bayesian Optimal Interval Design (BOIN) to define dose escalation and de-escalation rules based on the proportion of patients experiencing a dose-limiting toxicity (DLT). DLT events are Grade 3 events possibly, probably, or definitely related to the study intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Stereotactic Body Radiation | Experimental | Radiation: Adaptive Stereotactic Body RadiationSimulation and treatment to be performed over 3-4 weeks per dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target lesion untreated by radiation, IR techniques, or growing in the abdomen or pelvis. Adjacent lymph nodes in the same region (5 cm or closer) constitute one active lesion. Target lesion must be measurable according to RECIST v 1.1. Previous systemic therapies are allowed.
- Age > 18 years.
- ECOG performance status 0 or 1
- Estimated survival of >/= 12 months
- Subjects must have normal organ and marrow function as defined below
Key exclusion criteria (9 listed)
- Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia and fatigue.
- Subjects must not be receiving any other investigational agents.
- Subjects must not have known peritoneal carcinomatosis visible on imaging.
- Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
- Subjects must not have 6 or more active metastatic sites.
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 |
|---|---|---|
| Adaptive Stereotactic Body RadiationRadiation therapy is given following generation of planning imaging at the time of simulation. A recent development has been diagnostic quality onboard imaging incorporated within radiation treatment machines. The incorporation of onboard imaging into standard practice has allowed the use Stereotactic Body Radiation (SBRT), which is a precise radiation technique that allows safe delivery of ablative radiation doses. More recently, the development of improved technologies and software have allowed radiation plans to be generated and delivered that are specific to the anatomy of the very moment the patient is being treated. This novel ability to adjust the radiation treatment plan based upon real time imaging is termed adaptive radiation therapy. This study will utilize the novel adaptive radiation therapy technology in a patient population with technically challenging disease to deliver ablative radiation with an appropriately low toxicity rate. | Radiation | Adaptive Stereotactic Body Radiation |
Primary outcome
To assess the ability of adaptive SBRT to deliver increased doses of radiation safely to patients with challenging anatomical locations of metastatic disease without causing unacceptable toxicity.
Time frame: 3 months
Cohorts of size 10 will be enrolled, Severe (grade 3) toxicity occurring within 3 months of treatment that is possibly, probably, or definitely related to trial therapy will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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.
Joshua Meyer, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adaptive Stereotactic Body Radiation in people with Neoplasm - Soft Tissue Pelvis Malignant Secondary and Malignant Neoplasm of Stomach, run by Fox Chase Cancer Center 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 12 inclusion and 9 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: paused, as of the sponsor's last update on 2 Nov 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To assess the ability of adaptive SBRT to deliver increased doses of radiation safely to patients with challenging anatomical locations of metastatic disease without causing unacceptable toxicity. (time frame: 3 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 2 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.