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

Subjects will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.

Subjects will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.

Fractionated Stereotactic Radiotherapy

Harold P Lau, MD

Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments.

You will be positioned in a special body mould while you are lying in the treatment position. This ensures that you are treated in the exact position each time. A soft plastic sheet may be placed over your body from the chest down. A vacuum device may be used to apply the sheet gently over you. This mild compression will ensure that you can breathe comfortably but will minimize any movement which may affect the accuracy of your treatments.

A CT (computed tomography) scan will be done for your treatment planning. The CT scan will take approximately 45 minutes. In some cases, intravenous dye may be administered during the CT scan. You will be asked to hold your breath for a short time during the CT scan. If you are unable to hold your breath comfortably, the scan will be performed during your normal breathing cycle. In some cases, your doctor may also order a PET (positron emission tomography) scan. The treatment planning to be done by your oncologist and physicist will take approximately one to two weeks. After that is completed, your treatments will begin. Each treatment will take about 30 minutes.

If the CT scans show that there is a lot of movement of your lung cancer due to breathing motion, your oncologist may recommend the insertion of a "fiducial" marker to help guide your treatments. An additional consent form will be obtained prior to this procedure. The "fiducial" marker is a tiny gold or stainless steel coil measuring about one inch long. It would be inserted into your lung in or next to the tumour by a respirologist via bronchoscopy under sedation. The procedure would take approximately 30 minutes, and you would be in hospital for about 4 hours. You would meet the respirologist in the clinic in consultation prior to the procedure so that he/she can tell you more about the procedure and assess your case in details to determine if it is safe for you to undergo the procedure. The insertion of the fiducial marker is considered part of your clinical care and a separate consent will be required prior to this procedure. You may choose not to undergo this procedure but still participate in this study. In some cases, your respirologist may have already inserted a fiducial marker at the time of diagnostic bronchoscopy after discussions with yourself and your radiation oncologist. The "fiducial" marker would be used to guide your radiation treatments during your normal breathing cycle.

You will be assigned into one of the two study groups described below depending on the location of your tumour:

Schedule I (10 fractions): You will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.

Schedule II (4 fractions): You will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.

Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours

Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours

Each schedule will be evaluated according to the occurrence of DLTs observed.

AHS Cancer Control Alberta

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Neoplasms, Second Primary

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases

The regular fraction modes were as follows: a. lesions≥3 cm：52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm：36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm：40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem：50-60Gy/2.5-3Gy/20f.

concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2\*5d, q28d, 6cycles

Jianping Xiao

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial

defined as no progress of the treated lesions and no distant progress in the brain

Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD

assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system

collect the data of causes of death and analyze

Cancer Foundation, China

Chinese Academy of Medical Sciences

stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy

hypo fractionated stereotactic radiotherapy in 5 fractions of 7 Gy up to 35 Gy. Brain stem metastases 5 fractions of 6 Gy up to 30 Gy

fSRT

Jaap D Zindler, MD, PhD

Mirjam Mast, PhD

Jaap Zindler, Dr

Ursula Fisscher, PhD

Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.

Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).

median survival with Kaplan Meyer analysis

incidence of RN or LF within 2 years after SRT

incidence of salvage treatment within 2 years after SRT

incidence of distant brain recurrences within 2 years after SRT

incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT

Haaglanden Medical Centre

Principal Investigator, MD, PhD, radiation oncologist

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.

The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

fractionated stereotactic radiotherapy

Jianping Xiao, Dr

A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.

FSRT Combined With TMZ for Large BMs: a PSM Study

Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study

the interval from the beginning of radiation to any intracranial progression

the time from the beginning of radiation to local faliure.

the time from the beginning of radiation to follow-up or death

the interval from the beginning of HFSRT to any progression of tumor.

the internal from the beginning of radiation to death that caused by brain metastases.

Rare Diseases

Recurrence

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Dose level 1:100 mg qd, 2:200 mg qd, 3:300 mg qd. Fractionated Stereotactic Radiotherapy: all patients will receive 36 Gy of radiation in three fractions, given in three consecutive days.

Dose level 1:100 mg qd Dose level 2:200 mg qd Dose level 3:300 mg qd

Vandetanib

All patients will receive 36 Gy of radiation in three fractions, given in three consecutive days.

Changhu Chen, MD

The purpose of the study is to find out the highest dose of vandetanib that can be safely given with repeat radiation therapy.

This study drug has been designed to block certain chemical pathways that stimulate tumor to grow. The study drug has been shown to slow the growth of a number of types of cancers.

This will be a dose escalation study. A dose escalation study means that successive groups of patients will receive higher doses of the study drug. There are three dose levels. The dose of the study drug received will depend on the stage the study has reached at the time a patient decides to participate.

In addition to taking the study drug patients will also receive radiation therapy to the brain tumor for 3 days.

Hypothesis The objective of this study is to determine the maximally tolerated dose (MTD) of VANDETANIB given with 36 Gy hypofractionated stereotactic radiotherapy. The MTD will be dose of VANDETANIB at which no patients develop acute grade 5 toxicity and less than 30% of patients develop acute (within 30 days of radiation therapy) or delayed (at least 30 days after radiation completed) dose limiting toxicities.

Screening Prior to receiving any treatment, tests will be performed to determine overall medical condition. This will include blood tests, questions about medical history, and physical and neurological exams.

MRI scan of the brain, electrocardiogram (ECG) and chest X-ray will be performed as baseline studies if they have not been performed in the last 28 days.

Women of child-bearing potential will also have a serum pregnancy test within 2 days before taking the study drug.

During treatment If all of the study criteria are met and subject is enrolled in the study, you will start taking the study drug at least 7 days before radiation therapy. You will take the study drug once a day by mouth. You should take the study drug at about the same time each day. If you forget to take a dose, take the missed dose as soon as you remember, as long as it is at least 12 hours before the next dose is due. If it is less than 12 hours until the next dose, do not take the dose you have missed. If you throw up within 30 minutes after you take the study drug, you should take another dose, and use medicine to stop or relieve your vomiting per your doctor's instruction. You will continue to take the study drug for a total duration of one year. The study will be stopped if your disease progresses or there is excessive toxicity. Your participation in the study will be for one year. However, we will continue to follow your disease status, general health and possible treatment-related side effects after one year and for as long as possible.

This is a Phase I study. These types of studies usually include a small number of subjects and are often called dose-escalation studies. Subjects in the first dose group will be receiving a small dose of the study drug. If no unacceptable side effects are observed in these subjects, the next group of subjects will receive the next higher dose of study drug. The study drug doses planned are as follows:

Dose Level Drug dose Level 1 100 mg once a day Level 2 200 mg once a day Level 3 300 mg once a day

You will be assigned to one of three levels depending on when you enter the study.

You will also receive radiation therapy. The radiation dose is the same for all patients. Radiation therapy will begin at least 7 days after you begin taking the study drug. The radiation therapy will be once a day for 3 consecutive days. A special plastic mask will be made for you and used to hold your head still during each radiation treatment.

Tests and procedures will be performed throughout your treatment to determine how your cancer is responding and to monitor you for safety purposes. The tests and procedures will be scheduled for you. The following tests and procedures will be performed:

* Physical examination, neurological examination, and ECG, right before, and in the first, second, fourth, eighth and twelfth week of drug treatment; then once every three months.
* Brain MRI and quality of life questionnaires at one month and three month after radiation therapy, then once every three months.
* Chest X-ray as your doctor determines.

Follow-up You will also have follow-up visits with your doctor once a month for the first 6 months, then once every three months. You may also see your doctor anytime as needed.

Duration You will be on this study for up to 12 months.

Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas

A Phase I Dose Escalation Study of Vandetanib (ZACTIMA, ZD6474) With Hypofractionated Stereotactic Radiotherapy in Patients With Recurrent Malignant Gliomas

AstraZeneca

University of Colorado, Denver

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Stereotactic Radiotherapy

A new type of treatment called stereotactic radiotherapy has recently been developed in hopes of improving the success of the treatment and improving the convenience to patients, while reducing the side effects. This study is developing stereotactic radiotherapy as a state-of-the-art treatment for lung cancer patients.

OBJECTIVES:

Primary Objectives

* To determine the efficacy of hypofractionated, image guided radiotherapy in treating patients with lung tumours, with the primary outcome being local control at one year.
* To determine the toxicity of high dose, small field,hypofractionated radiotherapy to the lung, based on the RTOG and CTCAE scales.

Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer

Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

Cross Cancer Institute

Hypofractionated SRT (stereotactic radiotherapy)

Historical single-dose SRS (stereotactic radiosurgery)

Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.

Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.

HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.

Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.

To investigators knowledge, SRS and HSRT have not been prospectively compared.

Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.

Association de Neuro-Oncologues d'Expression Francaise

Centre Francois Baclesse

Meningeal Carcinomatosis

Meningeal Neoplasms

Anti-Infective Agents

Cytarabine

Meningeal Metastases, with or without brain metastases

1. the prescription of tomotherapy: whole brain radiation (WBRT) with 40Gy in 20 fractions and concurrent boost of 60Gy of the leptomeningeal metastases;
2. WBRT of 50Gy in 25 fractions, with dose limitation of hippocampus and brain stem; c.TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2\*5d, q28d, up to 6cycles.

d. Some patients received intrathecal chemotherapy (MTX+AraC+Dex) based on the cytology of cerebrospinal fluid (CSF).

tomotherapy

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for leptomeningeal metastases.

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for leptomeningeal metastases, which are defined as leptomeningeal metastases with or without brain metatstases.

Tomotherapy for Leptomeningeal Metastases

Tomotherapy for Leptomeningeal Metastases: a Single Arm, Single Center, Phase II Trial

the time from radiation to leptomeningeal lesion recurrence

the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases

the time from radiation to any progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours	NCT00351962	Lung Neoplasms Lung Cancer	Fractionated St...	18 Years -	AHS Cancer Control Alberta
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases	NCT02654106	Brain Metastase...	Fractionated St... Temozolomide	18 Years - 75 Years	ChineseAMS
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases	NCT05346367	Brain Metastase...	SRT fSRT	18 Years -	Haaglanden Medical Centre
FSRT Combined With TMZ for Large BMs: a PSM Study	NCT03338075	Brain Metastase... Radiotherapy Chemotherapy	fractionated st...	18 Years -	ChineseAMS
Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas	NCT00822887	Malignant Gliom...	Vandetanib Fractionated St...	18 Years -	University of Colorado, Denver
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases	NCT05346367	Brain Metastase...	SRT fSRT	18 Years -	Haaglanden Medical Centre
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer	NCT00888823	Non-small Cell ...	Stereotactic Ra...	18 Years -	AHS Cancer Control Alberta
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases	NCT02654106	Brain Metastase...	Fractionated St... Temozolomide	18 Years - 75 Years	ChineseAMS
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours	NCT00351962	Lung Neoplasms Lung Cancer	Fractionated St...	18 Years -	AHS Cancer Control Alberta
Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (310 Gy) to the Historical Single-dose Radiosurgery (120 to 25 Gy) With Medico-economic Evaluation.	NCT05102747	Brain Metastasi... Oligoprogressio...	Hypofractionate... Historical sing...	18 Years -	Centre Francois Baclesse
Tomotherapy for Leptomeningeal Metastases	NCT04178343	Leptomeningeal ...	tomotherapy	18 Years - 75 Years	ChineseAMS
Tomotherapy for Leptomeningeal Metastases	NCT04178343	Leptomeningeal ...	tomotherapy	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for fractionated stereotactic radiotherapy