RECRUITING

Adaptive Radiation for Abdominopelvic Metastases

Conditions

Neoplasm - Soft Tissue Pelvis Malignant Secondary Malignant Neoplasm of Stomach

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adaptive Radiation for Abdominopelvic Metastases (ARAM)

Quick Facts

Study Start:2023-08-01

Study Completion:2029-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05880667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Age \> 18 years. 3. ECOG performance status 0 or 1 4. Estimated survival of \>/= 12 months 5. Subjects 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 subjects with creatinine levels above institutional normal 6. 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.	1. 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. 2. Subjects must not be receiving any other investigational agents. 3. Subjects must not have known peritoneal carcinomatosis visible on imaging. 4. Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging 5. Subjects must not have 6 or more active metastatic sites. 6. Subjects must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed. 7. 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. 8. Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s). 9. Subjects must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Age \> 18 years.
3. ECOG performance status 0 or 1
4. Estimated survival of \>/= 12 months
5. Subjects 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 subjects with creatinine levels above institutional normal
6. 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.

1. 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.
2. Subjects must not be receiving any other investigational agents.
3. Subjects must not have known peritoneal carcinomatosis visible on imaging.
4. Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
5. Subjects must not have 6 or more active metastatic sites.
6. Subjects must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed.
7. 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.
8. Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).
9. Subjects must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.

Contacts and Locations

Study Contact

Tanu Singh

CONTACT

12152141439

tanu.singh@fccc.edu

Joshua Meyer, MD

CONTACT

215-728-2667

Joshua.Meyer@fccc.edu

Principal Investigator

Joshua Meyer, MD

PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

Joshua Meyer, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01

Study Completion Date2029-06-01

Study Record Updates

Study Start Date2023-08-01

Study Completion Date2029-06-01

Terms related to this study

Additional Relevant MeSH Terms

Neoplasm - Soft Tissue Pelvis Malignant Secondary
Malignant Neoplasm of Stomach