Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Carcinoma, Neuroendocrine

Carcinoma, Large Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Participants receive stereotactic body radiotherapy (SABR) once a day for 3-4 days in a row.

50Gy delivered in 4 fractions for central tumor, or 54Gy delivered in 3 fractions for peripheral tumor.

SABR once a day for 3-4 days in a row, 50Gy in 4 fractions for central tumor, or 54Gy in 3 fractions for peripheral tumor.

Stereotactic Body Radiotherapy (SABR)

Jack Roth, MD, BA

The goal of this clinical research study is to evaluate the outcome of a standard radiation treatment called stereotactic radiotherapy (SRT) for NSCLC.

Specifically, researchers want to learn if standard SRT has as good of an outcome at 3 years after the procedure. The safety of the study treatment will also be analyzed.

The Study Treatment:

The treatment being used in this study is considered standard, but researchers want to see its outcome in early-stage NSCLC.

The radiation (SRT) in this study is designed to kill tumor cells by using beams of radiation aimed directly at the tumor from different angles. The doctor uses computed tomography (CT) scans to plan exactly where to direct the beams to go. A computer is used to show the location, size, and shape of the tumor. SRT is designed to cause less damage to normal tissue than surgery, and it also may allow a higher dose of radiation to be given to the tumor than if other forms of radiation therapy were used.

The SRT in this study will be performed using a radiation machine called Linear Accelerator (Linac).

Study Group:

If you are found to be eligible to take part in this study, you will receive SRT (as an out-patient) once a day for 3-4 days in a row. You will be asked to hold still during the entire treatment (for about 1 to 1 1/2 hours each time). The machine will move around you, but you will not see or feel anything (similar to getting an x-ray).

Follow-Up Visits:

During the treatment period, you will be seen by a doctor and/or research nurse in order to check for any side effects. A physical exam will be performed, and your medical history will be recorded. These follow-up procedures will be done once on any day of your SRT.

A physical exam will be performed and your medical history will be recorded at 6 and 12 months, then at 1 1/2, 2, 3, 4, and 5 years after your SRT. If the doctor decides it is necessary, you will have a chest x-ray to check the status of the disease.

At 6 to 12 months after SRT, you will have either a PET-CT scan or CT scan to check the status of the disease.

At 1 year after SRT, you will have breathing tests to check your lung function. You will also have a CT scan to check the status of your disease.

At 1 1/2 year and then at 2, 3, 4, and 5 years after SRT, you will have a CT scan to check the status of your disease.

Possible Re-Treatment On Study:

If one of your follow-up CT scans shows that the tumor has come back in the same location or very close, you will have a PET scan and a tumor biopsy. The purpose is to confirm the status of the disease. To collect a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tissue is withdrawn through a large needle.

As soon as the results of the scan and biopsy come back, the study doctor will discuss with you the different treatment options. You may receive surgery, radiation therapy, or chemotherapy, depending on the status of the disease. You will receive a separate consent form that describes the treatment in more detail, as well as the risks.

After this "re-treatment", you will stay on the same schedule for study follow-up visits as you were following before.

Length of Study Participation:

Your participation in this study will be over after the 5-year follow-up visit.

This is an investigational study. The treatment is commercially available and considered standard for early-stage NSCLC. This includes the use of the Linac radiation machine, which is FDA approved and commercially available.

Up to 80 treated patients will take part in this study. All will be enrolled at MD Anderson.

Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy

STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy

OS defined as the length of time measured from the start of treatment until 3 years post-treatment or death, whichever come first.

Varian Medical Systems

M.D. Anderson Cancer Center

These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery.

Surgery (S) vs. SBRT

SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (\>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival.

Stereotactic Body Radiation Therapy (SBRT) (R)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Jack Roth, MD- Professor, Thoracic & Cardio Surgery-Rsch

Number of Participants With Overall Survival (OS) at 3 Years

Overall Study

Symptoms and General Pathology

Disease Progression

Anti-Dyskinesia Agents

All Drugs and Chemicals

Neuroprotective Agents

Cardiotonic Agents

Memantine

Antiparkinson Agents

Dopamine

Dopamine Agents

Neurotransmitter Agents

Excitatory Amino Acid Antagonists

RT techniques and the dose schemes in the cohort of Hypofractionated Stereotactic Radiotherapy (HF-SRT)

The course of hippocampus-sparing whole-brain radiotherapy (HS-WBRT) combined with the synergic use of the neuroprotective agent, memantine

The administered dose-fractionation schemes range between 30 and 35 Gy delivered within two weeks with a dose per fractionation ranging from 6 to 7 Gy.

Hypofractionated Stereotactic Radiotherapy (HF-SRT)

* The prescribed dose is 30 Gy delivered in 12 fractions for therapeutic or adjuvant WBRT.
* The prescription of memantine for finally twice-daily dosing will be prescribed as follows:

  * During the first 3 weeks concurrent with the delivery of hippocampus-sparing WBRT, 5-mg morning dose will be initially prescribed \[Week 1 -3\]
  * 5-mg twice a day in the following week \[Week 4\]
  * A morning dose of 10 mg and an evening dose of 5 mg in the following week \[Week 5\]
  * 10-mg twice a day for the subsequent weeks up to Week 24 \[Week 6 - 24\]

Hippocampus-Sparing Whole-Brain Radiotherapy (HS-WBRT) plus memantine

Din-Li Tsan, M.D.

Shinn-Yn Lin, M.D.

\[Background\] For newly-diagnosed patients with brain metastases (BMs), conventional whole-brain radiotherapy (WBRT) might still remain a common palliative management. However, WBRT-related late consequences, particularly a decline in neurocognitive functions (NCFs), are a major concern. Actually, WBRT-related neurocognitive dysfunction is usually characterized as deterioration involving learning and memory, in which the extremely radiosensitive hippocampus indeed plays a critical role.

To postpone the occurrence and mitigate neurocognitive impairments associated with conventional WBRT, there have been some strategies in the clinical practice of radiation oncology. Among them, the technology/technique of highly precise/accurate stereotactic radiosurgery or stereotactic radiotherapy (i.e., hypofractionated stereotactic radiotherapy, HS-SRT) might have been widely administered in irradiating exclusively the focal brain metastatic lesions, particularly in cancer patients with a limited number of brain metastases. By contrast, the planning strategy of hippocampus avoidance during the course of whole-brain irradiation has also been well-established in preserving NCFs.

\[Methods\] Newly-diagnosed cancer patients harboring 1 - 4 brain metastatic lesions are eligible if they still have fair/good performance status. Eligible and enrolled should receive baseline brain MRI examination and pre-WBRT neurocognitive assessment. Although non-randomized, this phase II trial comprises two prospective (radiotherapeutic) cohorts with individually different planning techniques and prescription schedules. Cohort I represents patients referred for arranging partial-brain irradiation; namely, a course of hypofractionated stereotactic radiotherapy (HF-SRT) is delivered within 2 weeks with a cumulative dose of 3000 - 3500 cGy in 5 fractions. By contrast, Cohort II stands for patients referred for arranging the course of hippocampus-sparing WBRT (HS-WBRT), delivered within 3 weeks with a cumulative dose of 3000 cGy in 12 fractions, during which the planning technique of simultaneous integrated boost (SIB) is employed to focally escalate the dose irradiating the brain metastatic foci. Besides, adhering to several international clinical practice guidelines, the synergic use of the neuroprotective agent (memantine) will be routinely applied in the treatment Cohort II (HS-WBRT). In both treatment cohorts, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal and non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurocognitive functions.

The primary outcome measure is the median time of CNS progression-free survival (CNS-PFS). Secondary outcome measures encompass both neuro-oncological endpoints and neurocognitive endpoints, among which there is cognitive-deterioration-free survival (CD-free survival). CD-free survival is defined mainly as the time from enrollment to a NCF decline of exceeding than 1 SD away from the baseline involving at least one of the assessed NCF tests. Additionally, patients who expire before 6 months or are alive but fail to undergo all the neurocognitive testing administered would also be defined as suffering from cognitive deterioration.

\[Expected results\] This prospective observational study aims to examine thoroughly and analyze the comparatively between the two radiotherapeutic cohorts (HF-SRT versus HS-WBRT), addressing both CNS tumor control and neurocognitive functional outcomes. It is expected that the patterns of (CNS) failure and individual time to progression will be clearly demonstrated in this prospective observational study encompassing two distinct radiotherapeutic cohorts.

HF-SRT vs. HS-WBRT in Treating Patients With Brain Oligometastases

Hypofractionated Stereotactic Radiotherapy Versus Hippocampus-sparing Whole-brain Radiotherapy in Treating Cancer Patients With Brain Oligometastases: A Phase II Parallel Non-randomized and Prospective Observational Study

The median CNS progression-free survival (CNS-PFS), which is a time-dependent endpoint, defined as the time from study enrollment to CNS disease progression of death from any cause.

The time from enrollment to a cognitive decline of exceeding more than 1SD away from the baseline in at least one of the assessed NCF tests. Furthermore, regarding cognitive-deterioration-free survival, patients who expire before 6 months or are alive but do not undergo all the neurocognitive testing administered or even fail to receive MMSE evaluation would be assumed reasonably that they suffer cognitive deterioration at the time of death or at the time point, or they fail to receive their first neurocognitive assessment follow-up as long as there are no subsequent NCF assessments.

Three patterns of central nervous system (CNS) failure were classified particularly when the CNS progression in the corresponding patient manifests for the first time after the course of HF-SRT: intracranial local failure (LF), distant brain parenchymal failure (DPF), and development of leptomeningeal disease (LMD).

Intracranial PFS or CNS progression-free survival; CNS progression-free survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy	NCT02357992	Lung Cancer	Stereotactic Bo...	18 Years -	M.D. Anderson Cancer Center
HF-SRT vs. HS-WBRT in Treating Patients With Brain Oligometastases	NCT05807165	Brain Oligometa...	Hypofractionate... Hippocampus-Spa...	20 Years - 85 Years	Chang Gung Memorial Hospital
Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy	NCT02357992	Lung Cancer	Stereotactic Bo...	18 Years -	M.D. Anderson Cancer Center

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