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

ConditionsInvasive Ductal Breast CarcinomaInvasive Ductal Breast Carcinoma Stage IVLobular Breast CarcinomaLobular Breast Carcinoma Stage IVNon Small Cell Lung CancerNSCLCGastrointestinal CancerGastrointestinal Squamous Cell CancerGastrointestinal AdenocarcinomaPancreatic CancerBladder CancerRenal Cell CarcinomaMelanomaSarcomaMetastatic Solid Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 extracranial metastatic disease measuring at least 5 cm in a single axis. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines.

Age ≥ 18 years

ECOG Performance Status of 0 or 1.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Palliative radiotherapy

    Radiation

    Palliative radiotherapy (RT) will be performed using external beam ionizing radiation in accordance with standard practice

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Participants with metastatic solid tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks from baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Varian Medical Systems

Collaborator

Source ClinicalTrials.gov
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