Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Neoplastic Processes

Hematinics

All Drugs and Chemicals

Liver Extracts

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach

stereotactic radiation therapy (SRT)

Fiorenza De Rose, MD

Tiziana Comito, MD

Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.

Investigators designed a prospective phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) scheduled for oligometastatic breast cancer patients unsuitable for surgery with age major than 18 years old and with adequate performance status (ECOG), using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer

Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer

Istituto Clinico Humanitas

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles, prior to surgery. Pembrolizumab will be administered via IV infusion for 30 minutes. Surgery will occur no later than 6 weeks following the last dose of pembrolizumab.

Patients will receive 200mg pembrolizumab on Day 1 of each 3 week cycle, for 2 cycles. Pembrolizumab will be administered via IV infusion for 30 minutes.Within the week (7 days +/- 3 days) following administration of the second cycle, a single 12 Gy dose of stereotactic radiation therapy (SRT) will be delivered to 50% of the primary tumor only. Definitive surgical resection will occur no later than 6 weeks following the last dose of pembrolizumab.

All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.

Patients in Cohort 2 of the Safety run-in and patients in the expansion cohort who are randomized to the 'pembrolizumab +radiation arm' will receive one dose of SRT within 1 week (+/- 3 days) following the second administration of pembrolizumab.

Standard of care surgery to remove cancer

Surgery (Non-interventional, standard of care)

Sue Yom, MD

This is a randomized single-institution, phase II, open-label clinical trial of neoadjuvant pembrolizumab with or without low-dose stereotactic radiation therapy (SRT) in stage I-IIIA non-small lung cancer (NSCLC) patients who are planned to undergo surgical resection of their lung cancer.

Two consecutive run-in cohorts will administer pembrolizumab or pembrolizumab with SRT of 12 Gy to the lateral aspect of the primary tumor. Patients will receive pembrolizumab for 2 cycles prior to surgery or SRT and surgery. Surgical resection of all involved areas of tumor will occur within 6 weeks of the last administration of pembrolizumab. It should be noted that surgery is expected to occur within a much shorter window and 6 weeks would represent the greatest allowable amount of delay.

If during the run-in, only the pembrolizumab-alone cohort meets pre-specified safety parameters, subsequently enrolled patients will enter a larger expansion cohort, with treatment given according to that cohort only. If during the run-in both cohorts meet pre-specified safety parameters, subsequently enrolled patients will enter the expansion cohort and be randomized between preoperative pembrolizumab versus pembrolizumab with SRT of 12 Gy.

Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer

PembroX: Enhancing the Immunogenicity of Non-Small Cell Lung Cancer With Pembrolizumab +/- Stereotactic Radiotherapy Delivered in the Preoperative Window, A Randomized Phase II Study With Correlative Biomarkers

The primary endpoint for this study is the change in number of infiltrating CD3+ T cells/ μm2 in the lung cancer tissue from before and after pembrolizumab +/- SRT, based on quantification using immunohistochemistry (IHC) and image analysis.

Proportion of patients achieving a two-fold increase from baseline. The goal of achieving a two-fold increase in 40 percent (%) of the evaluable population is a reasonable one, as estimated from a previous study showing greater-than-three-fold increase in 57% of patients when CD3+ T cells/um2 were measured in prostate cancer tissue treated with a cell- based cancer immunotherapy

Adverse events with an attribution of possible, probable, or definite according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4 including immune-related AEs will be considered treatment related

Participant safety is defined as \<= 33 percent (%) grade 3 immune-related adverse events according to the CTCAE v. 4

Defined as the time from treatment initiation until death. Participants alive at the end of 12 months will be censored.

Defined as the time from treatment initiation until disease progression. Participants who have not progressed at the end of 12 months will be censored.

The rate of distant metastases at 12 months will be reported

The rate of progression to unresectability following the preoperative program will be reported

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer	NCT02581670	Breast Cancer Metastasis to L... Metastasis to L...	stereotactic ra...	18 Years -	Istituto Clinico Humanitas
Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer	NCT03217071	Non Small Cell ...	Pembrolizumab stereotactic ra... Surgery (Non-in...	18 Years -	University of California, San Francisco
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer	NCT02581670	Breast Cancer Metastasis to L... Metastasis to L...	stereotactic ra...	18 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for stereotactic radiation therapy (srt)