Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

10 Gy dose delivered to the primary tumor \& 10 Gy to the hilar (N1) node over 5 fractions

10 Gy dose delivered to the primary tumor \& 9 Gy to the hilar (N1) node over 5 fractions

10 Gy dose delivered to the primary tumor \& 8 Gy to the hilar (N1) node over 5 fractions

The maximum tolerated radiation dose to the hilar (N1) node from the run-in period will be used during Phase 2.

SABR will be delivered to the primary disease and hilar (N1) node over 5 fractions.Reductions may be made to the hilar (N1) node according to a 3+3 design during the run-in period.

Stereotactic Ablative Radiation Therapy (SABR)

Tim Lautenschlaeger, MD

Conventionally fractionated radiation therapy given over 6-7 weeks alone, sequentially, or concurrent with chemotherapy have produced poor outcomes in Stage II NSCLC in most series. Stereotactic ablative radiotherapy (SABR) has been shown to be very effective and is now standard of care for Stage 1 disease. There has been initially reluctance to utilize SABR for central lung tumors because of published reports that showed an excess of toxicity when SABR was utilized; however, newer data with less intense treatment regimens suggest safety in treatment of central lung disease. The safety and efficacy of SABR in treating hilar nodes or N1 disease currently is not known fully and will be evaluated in this study.

1. Primary Objectives Safety run-in - To determine the safety of SABR for the treatment of primary lung disease and N1 (hilar) node in stage T1-2a N1 NSCLC Phase II - To determine 2-year local control of SABR for T1-2a N1 NSCLC with sequential chemotherapy
2. Secondary Objectives Phase II - To determine overall and progression-free survival times, pattern of failures, and rates of ≥ grade 3 adverse events after SABR for T1-2a N1 NSCLC combined with sequential chemotherapy

This is a Phase II single-institution trial with a 3 + 3 safety run-in period. SABR will be delivered per protocol, followed by a planned 4 cycles of sequential chemotherapy within 3-8 weeks after the completion of SABR. Four cycles of chemotherapy shall be planned as typically used for adjuvant chemotherapy following surgical resection for T1-2aN1 non-small cell lung carcinoma (NSCLC) unless otherwise indicated by institutional guidelines.

SABR for T1-2a N1 NSCLC

Phase II Evaluation With Safety Run-in of Stereotactic Ablative Body Radiation for T1-2a N1 Non-Small Cell Lung Cancer

Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

Failure of disease progression within or immediately adjacent to the treatment planning target volume (PTV) of the lung primary and nodal disease. Failures will be classified as local failures if failing within or immediately adjacent to the N1 or primary tumor PTV, unless judged by the investigator team to convincingly be a separate lesion from the treated lesion (i.e. new lesion within PTV but across a fissure)

Length of time during and after the treatment that a patient lives with the disease but it does not get worse

Length of time start of treatment that patients are still alive

Any event per CTCAE v.4 that occurs within 1 year from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

Indiana University School of Medicine

Indiana University

Assistant Professor of Radiation Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.

Prostate radiation (XRT)

All systemic therapy is provided as best prescribed for patient per their medical oncologist.

Systemic Therapy

SABR is delivered to those randomized to Arm 2.

Stereotactic ablative radiation therapy (SABR)

Phuoc Tran, MD

Nicole Helie

Lalicia Roman

Caitlin Eggleston

Pilar Strycula, RN, BSN

This research is being done to determine if we can improve the outcome of prostate cancer patients who have failed primary treatment - surgery or local radiation to the prostate - and have three or fewer bone or soft tissue metastases.

This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.

TERPS Trial for de Novo Oligometastic Prostate Cancer

Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial

Cross-over to the SABR MDT is allowed following failure.

Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.

Progression will be assessed for time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization to best systemic therapy (BST) and primary prostate radiation (XRT) versus BST, XRT and stereotactic ablative radiation therapy (SABR) metastasis-directed therapy (MDT).

EPIC quality of life tool will be used to assess quality of life following treatment. This survey will be completed at baseline and during follow-up visits. Averages will be taken for each section in the survey (Urinary Function, Bowel Function, Sexual Function, and Hormonal function).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SABR for T1-2a N1 NSCLC	NCT03321760	Lung Cancer	Stereotactic Ab...	18 Years -	Indiana University
TERPS Trial for de Novo Oligometastic Prostate Cancer	NCT05223803	Prostate Cancer Oligometastatic...	Prostate radiat... Systemic Therap... Stereotactic ab...	18 Years -	University of Maryland, Baltimore
TERPS Trial for de Novo Oligometastic Prostate Cancer	NCT05223803	Prostate Cancer Oligometastatic...	Prostate radiat... Systemic Therap... Stereotactic ab...	18 Years -	University of Maryland, Baltimore

Spots Global Cancer Trial Database for stereotactic ablative radiation therapy (sabr)