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New treatment option for Neoplasm - Soft Tissue Pelvis Malignant Secondary
Official title Adaptive Radiation for Abdominopelvic Metastases
ClinicalTrials.gov ID: NCT05880667
What this study is testing
- What it's testing
- 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%.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target...
- Age \> 18 years.
- ECOG performance status 0 or 1
- Estimated survival of \>/= 12 months
- people must have normal organ and marrow function as defined below
You likely can't join if
- people must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory...
- people must not be receiving any other investigational agents.
- people must not have known peritoneal carcinomatosis visible on imaging.
- people must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
- people must not have 6 or more active metastatic sites.
- people must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed.
See the full eligibility criteria
- people 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...
- Age \> 18 years.
- ECOG performance status 0 or 1
- Estimated survival of \>/= 12 months
- people must have normal organ and marrow function as defined below
- Absolute neutrophil count \> 1,500/mcL
- 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 people with creatinine levels above institutional normal
- people 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...
- people 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...
- people must not be receiving any other investigational agents.
- people must not have known peritoneal carcinomatosis visible on imaging.
- people must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
- people must not have 6 or more active metastatic sites.
- people must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed.
- people 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...
- Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).
- people must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.