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Adaptive Radiation for Abdominopelvic Metastases

Primary Purpose

Neoplasm - Soft Tissue Pelvis Malignant Secondary, Malignant Neoplasm of Stomach

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adaptive Stereotactic Body Radiation
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm - Soft Tissue Pelvis Malignant Secondary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Fox Chase Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adaptive Stereotactic Body Radiation

Arm Description

Simulation and treatment to be performed over 3-4 weeks per dose escalation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2023
Last Updated
September 19, 2023
Sponsor
Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05880667
Brief Title
Adaptive Radiation for Abdominopelvic Metastases
Official Title
Adaptive Radiation for Abdominopelvic Metastases (ARAM)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
June 1, 2028 (Anticipated)
Study Completion Date
June 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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%. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm - Soft Tissue Pelvis Malignant Secondary, Malignant Neoplasm of Stomach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Stereotactic Body Radiation
Arm Type
Experimental
Arm Description
Simulation and treatment to be performed over 3-4 weeks per dose escalation
Intervention Type
Radiation
Intervention Name(s)
Adaptive Stereotactic Body Radiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanu Singh
Phone
12152141439
Email
tanu.singh@fccc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Meyer, MD
Phone
215-728-2667
Email
Joshua.Meyer@fccc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Meyer, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua E. Meyer, MD
Phone
215-728-2667
Email
joshua.meyer@fccc.edu
First Name & Middle Initial & Last Name & Degree
Joshua E. Meyer

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptive Radiation for Abdominopelvic Metastases

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