A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

Pancreatic Cancer Clinical Trial

Official title:

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837767
• Other study ID #: 22-207
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: July 24, 2026

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Atif Khan, MD
• Phone: 848-225-6334
• Email: khana7[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: July 24, 2026
• Est. primary completion date: July 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with biopsy confirmed advanced/metastatic solid tumors of the following types: invasive ductal or lobular breast carcinoma (all histological and intrinsic subtypes), non-small cell lung cancer (NSCLC, all subtypes), gastrointestinal squamous cell or adenocarcinomas (including pancreatic cancer), bladder cancer, renal cell carcinoma, melanoma, and soft tissue sarcoma (all subtypes), who require and are being planned for palliative radiation therapy to at least one site of RECIST-measurable extracranial metastastic disease. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines.

• Patients with at least one additional site of RECIST-measurable extracranial metastasis measuring at least 4 cm in one axis and suitable for elective palliative radiation therapy. Patients should be asymptomatic or minimally symptomatic (e.g controlled by oral pain medications) and not in urgent need for palliation to this site of elective experimental treatment.

• Age = 18 years

• ECOG Performance Status of 0 or 1.

Exclusion Criteria:

• Patients who are pregnant or breastfeeding

• Prior radiation therapy to the candidate metastatic sites under consideration for treatment ("re-irradiation" is disallowed).

• Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.

• Patients with a "currently active" metastatic second malignancy.

• Patients on oral or parental corticosteroids. Physiological doses of steroids are permitted (eg for patients with adrenal insufficiency). If patients are on supraphysiological doses of steroids, these must be discontinued and held during the period of the study.

• Concomitant anti-neoplastic treatment is not allowed during the days of radiation treatment delivery and should be completed or held for 3 days prior to commencement of protocol treatment and for 3 days following completion of radiotherapy, or with resolution of associated acute toxicities.

• Unwilling or unable to participate in all required study evaluations and procedures.

• Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Neoplasms
• Carcinoma
• Carcinoma, Ductal, Breast
• Carcinoma, Lobular
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Carcinoma, Squamous Cell
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Invasive Ductal Breast Carcinoma
• Lobular Breast Carcinoma
• Melanoma
• Metastatic Solid Tumor
• Neoplasms, Squamous Cell
• Non Small Cell Lung Cancer
• NSCLC
• Pancreatic Cancer
• Pancreatic Neoplasms
• Renal Cell Carcinoma
• Sarcoma
• Urinary Bladder Neoplasms

Intervention

Radiation:
• Stereotactic body radiotherapy
The primary site requiring palliative radiotherapy will receive conventional SBRT dosing of SBRT (or an alternate standard-of-care schedule).
• Lattice Radiation Therapy
A second metastatic site (GTV volume at least 100 cc) will receive elective palliation with a lattice RT pattern (LRT).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited protocol activities)	Rockville Centre	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	The primary endpoint is ORR in the LRT-treated lesion, as defined by RECIST v.1.1 criteria, at 12 weeks on a standard-of-care response assessment CT or F-18-FDG PET/CT scan after LRT.	12 weeks from baseline

External Links

•   Memorial Sloan Kettering Cancer Center