Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Patients received PCI (recommended hippocampal protection) within 6 weeks after first-line treatment, with a total dose of 25 Gy, 2.5 Gy each time, once a day, 5 times a week, a total of 10 times. Brain enhancement MRI examination is performed every 3 months in first two years, and then performed every 6 months until the brain metastasis occur.

Patients undergo enhancement MRI examination every 3 months in first two years, and then performed every 6 months until the brain metastasis occur. Once brain metastases occur, brain radiotherapy and systemic treatment should be conducted with the follow-up observation of brain enhancement MRI continuing.

MRI Surveillance

Prophylactic Cranial Irradiation

Jinming Yu, PhD

Xiangjiao Meng, PhD

This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. MRI surveillance alone (delaying radiation until the actual brain metastasis) may be not inferior to PCI.

Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy: a Multicenter Randomized Controlled Phase III Clinical Trial

To compare the efficacy of PCI and MRI surveillance in patients with LS-SCLC.

To compare brain metastasis rate between the two arms.

To compare the neurocognitive toxicities of PCI and MRI surveillance in patients with LS-SCLC.

Shandong Cancer Hospital and Institute

Director of Shandong Cancer Hospital and Institute

Symptoms and General Pathology

Nervous System Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

All studied patients should undergo a computed tomography (CT) simulation scan encompassing the entire head region with 1.25-mm slice thickness using a thermoplastic mask for immobilization. To achieve conformal hippocampal sparing during the delivery of WBRT, the technique of volumetric modulated arc therapy (VMAT) via Linac-based RapidArc® or TrueBeamTM is employed in our treatment planning. All treatment plans are delivered by using the Linac Varian-iX or TrueBeamTM. In terms of dose prescription, a dose of 30 Gy in 15 fractions is prescribed to whole-brain planning target volume (PTV) under the setting of prophylactic cranial irradiation for NSCLC patients.

hippocampal-sparing WBRT

Chi-Cheng Yang, Ph.D.

Shinn-Yn Lin, M.D.

Background. During the clinical course of patients with locoregionally advanced non-small-cell lung cancer (LA-NSCLC) who have undergone aggressive treatment, brain metastasis (BM) is a frequent seen pattern of disease relapse, which cannot be ignored. It still remains unresolved whether prophylactic cranial irradiation (PCI) via whole brain radiotherapy (WBRT) should be recommended for NSCLC patients with stage III or pathologically nodal positive disease. Actually, PCI would significantly decrease the incidence of BM; however, potential WBRT-related neurocognitive function (NCF) sequelae are indeed a concern, which has made PCI seldom applied in clinical practice. In terms of the time course of WBRT-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involve impairments of episodic memory, which has been significantly associated with functions of the hippocampus. This study thus aims to explore the impact of PCI on the subsequent risk of developing BM and the multi-domain neurobehavioral functions in our eligible patients.

Methods. Potentially eligible subjects are postoperative NSCLC patients with a status of pathologically nodal metastasis (pN+). Patients randomly assigned to the PCI arm will undergo the course of hippocampal-sparing PCI after they complete the fourth course of adjuvant platinum-based chemotherapy. Radiotherapy dose will be 3000 cGy in 15 fractions during three weeks. Except for the administration of hippocampal-sparing PCI, patients assigned to the observation arm should receive the same baseline and follow-up brain imaging examinations and neurocognitive assessments as those in PCI arm. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal \& non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurobehavioral functions for our registered patients.

Expected results. This randomized controlled study aims to verify that the incidence of BM still can significantly be reduced by hippocampal-sparing PCI; additionally, NCF preservation regarding neurobehavioral assessments might also be achieved by hippocampal-sparing PCI as compared with the observation arm without PCI. No matter what the final results present, it is believed that this randomized controlled trial (RCT) will provide us solid evidence concerning the exact value of hippocampal-sparing PCI in our patient setting.

Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer

Neuropsychological and Oncological Outcomes After Hippocampal-Sparing Prophylactic Cranial Irradiation in Postoperative Patients With Pathologically Nodal Positive Non-Small-Cell Lung Cancer - A Prospective Follow-up Study

Neurocognitive assessment: including memory, executive functions, and psychomotor speed. This neurocognitive outcome was delayed recall, as determined by the change/decline in either verbal memory \[Wechsler Memory Scale - 3rd edition (WMS III) - Word List score\] or non-verbal memory (WMS III- Visual Reproduction score) from the baseline assessment to 4 months after the start of the course of WBRT with hippocampus avoidance (HA-WBRT). Additionally, the follow-up of neurocognitive assessment will also be administered at 12 months and up to 18 months after the start of PCI.

Chang Gung Memorial Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Carcinoma, Transitional Cell

Carcinoma, Small Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Small Cell Carcinoma of the Bladder

Prophylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks. On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.

Prophylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks.

Prophylactic Cranial Irradiation (PCI)

On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.

Brain X-ray

Seungtaek Choi, MD

The goal of this clinical research study is to learn if whole brain radiation can lower the chances of developing brain tumors in patients with small cell carcinoma of the urinary tract, including the bladder. The safety of whole brain radiation will also be studied.

Pregnancy Test:

Women who are able to have children must have a negative urine pregnancy test to be eligible for this study.

MRI/CT Scans:

Within six (6) weeks before having whole brain radiation, you will have a magnetic resonance imaging (MRI) or a computed tomography (CT) scan of your brain to check if brain tumors have developed.

Simulation Visit:

Before the radiation therapy begins, you will have a "simulation visit" to plan for the radiation therapy. During this session, you will be fitted to a plastic mask to hold your head still during radiation. The mask is made of a material called "thermoplastic" that becomes soft when it is placed in warm water. While this plastic is soft, it will be pulled over your face to make a mold. When the plastic cools down, it will harden again and the mask will be completed. After the mask is made, a CT scan of your head will be done for treatment planning.

Radiation Therapy:

You will begin radiation within 1 week after the simulation visit. You will have radiation visits Monday through Friday for 3 weeks (15 total therapy visits). Each therapy session will last about 15 minutes. It will take the study staff about 10 minutes to position you on the table and put the mask on. The radiation will be given over 2-3 minutes.

On the first day of each week of therapy, you will have a brain X-ray to see if the radiation is being given to the best area.

Follow-Up:

After the radiation therapy, you will have an MRI or a CT scan of the brain every 6 months for 1 year and then every year for 5 years to check the status of the disease. More frequent scans will be performed if your doctor thinks they are needed. You will also complete a written mental status exam with your doctor every 3-6 months for 2 years and then every year for 5 years. The exam will have a series of tests to check your memory and ability to follow instructions. The test will take about 15 minutes to complete.

Length of Study:

You may remain on study for as long as you are benefitting. You will be taken off study if your disease gets worse or if intolerable side effects occur.

This is an investigational study. The use of radiation to check for brain tumors before they have formed is investigational.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium

Prophylactic Cranial Irradiation (PCI) for Patients With Small Cell Carcinoma of the Urothelium

Primary outcome for this trial is the rate of development of brain metastasis by 12 months following start of treatment. A "success" defined as a patient not developing brain metastasis by 12 months following start of treatment. After radiation therapy, participant has an MRI or a CT scan of the brain every 6 months for 1 year.

M.D. Anderson Cancer Center

Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week

Hippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week

Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week

Prophylactic cranial irradiation (PCI)

Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week

Hippocampal avoidance PCI

Núria Rodríguez de Dios, MD PhD

The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients.

In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.

Prophylactic cranial irradiation (PCI) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (SCLC) who have shown benefit after chemotherapy with or without thoracic radiotherapy.

Because hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of PCI should result in lower rates of memory loss.

Previous studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (IMRT) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives.

The main objective of this trial is compare neurocognitive functioning following hippocampal avoidance PCI to standard PCI treatment measured by Free and Cued Selective Reminding Test (FCSRT). The FCSRT measures verbal learning and memory. The FCSRT emphasizes encoding specificity during learning and recall. One of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (MRI). Others objectives are to evaluate quality of life (QoL) and the rate of metastases in the hippocampus.

Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)

Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)

Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation

Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 6,12 and 24 months after radiation

Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation

Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation

Evaluation of adverse effects according to Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.0 at 3, 6, 12 and 24 months after radiation

Evaluation of Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)

From the start date of PCI until the date of death from any cause, or the last follow-up date whichever came first, assessed up to 60months"

Grupo de Investigación Clínica en Oncología Radioterapia

Principal Investigator

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Patients in the control group are enrolled in the follow-up, and the patients in research group will receive prophylactic cranial irradiation （PCI） by 25 gy/10 fx.

prophylactic cranial irradiation (PCI)

lobectomy + mediastinal lymph node dissection or systematic lymph node sampling

If the postoperatively pathological examination of the patient is confirmed to be in pT1-2N0 stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is recommended. If patients are difficult to tolerate the side effects of cisplatin, we can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme.

postoperative adjuvant chemotherapy

Peng Zhang, Doctor

Peng Zhang, doctor

At present, for participants with cT1-2N0 small cell lung cancer (SCLC), the International guidelines recommend surgical radical resection (lobectomy + systematic lymph node sampling or cleaning); If the postoperatively pathological examination is confirmed to be in pT1-2N0 stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is recommended. If participants are difficult to tolerate the side effects of cisplatin, the investigators can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme. Participants with pT1-2N0 SCLC are not recommended to receive postoperative chest-assisted radiotherapy. For participants with pT1-N0 SCLC after specific surgical resection, prophylactic cranial irradiation (PCI) is currently recommended. But this recommendation is currently lacking the support of research evidence.

The main purpose of this study is to study the prognostic effects of PCI on participants with pT1-2N0 stage small cell lung cancer (SCLC) who have received radical surgery and postoperative adjuvant chemotherapy.

The main endpoint of this study is to observe the total survival rate (5-year OS%) in 5 years.

The secondary outcome measures include 5 years of disease-free survival (5-year DFS%), disease-free survival (DFS), overall survival (OS), surgical complications, resection rates, quality of life (QoL), and exploration of biomarkers (tumor tissue).

This is a two-arm, open, multicentral clinical study designed to compare the 5-year OS% of participants receiving or not receiving PCI for pT1-2N0 stage small cell lung cancer (SCLC) with radical surgery plus postoperative adjuvant chemotherapy. Previous literature reports that the 5-year OS% of participants with pT1-2N0 period SCLC who have received surgical resection is about 50%. Assuming that PCI can increase 5 years OS% by 10%, then enrolling 320 participants in the group can guarantee 70% degree of certainty with observing a unilateral significant difference α\< 0.1. Taking about 10% of the follow-up loss rate into account, the investigators expect to enroll 360 participants.

Dividing the 360 participants divided into two groups randomly, each group is composed of 180 people. All participants received lobectomy plus mediastinal lymph node dissection or systematic lymph node sampling. Participants in the control group are enrolled in the follow-up, and the participants in research group will receive PCI by 25gy/10fx.

Clinical Study of Combined Radical Operation With Postoperative Adjuvant Chemotherapy and Prophylactic Cranial Irradiation in pT1-2N0M0 Stage of Small Cell Lung Cancer

Five-year survival rate measures survival at 5 years after surgery.

The rate that the patients whose disease doesn't recur take up in the total patients from the start of randomization to 5 years.

From the beginning of randomization to the time-point when the disease recurs or the patient dies due to disease progression.

Patients die directly from the progression of SCLC or from an unrelated cause (for example, a car accident). When the precise cause of death is not specified, this is called the overall survival rate.

The complications related to the operations that happen in the perioperative period.

The patients who are able to receive the radical resection.

To search the possible bio-makers for SCLC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy	NCT04829708	Limited Stage S...	MRI Surveillanc... Prophylactic Cr...	18 Years - 75 Years	Shandong Cancer Hospital and Institute
Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer	NCT02448992	Non-Small-Cell ... Brain Metastasi...	hippocampal-spa...	18 Years - 80 Years	Chang Gung Memorial Hospital
Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium	NCT00756639	Bladder Cancer	Prophylactic Cr... Brain X-ray	18 Years -	M.D. Anderson Cancer Center
Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium	NCT00756639	Bladder Cancer	Prophylactic Cr... Brain X-ray	18 Years -	M.D. Anderson Cancer Center
Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium	NCT00756639	Bladder Cancer	Prophylactic Cr... Brain X-ray	18 Years -	M.D. Anderson Cancer Center
Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)	NCT02397733	Small Cell Lung...	Prophylactic cr... Hippocampal avo...	18 Years -	Grupo de Investigación Clínica en Oncología Radioterapia
Clinical Study of Combined Radical Operation With Postoperative Adjuvant Chemotherapy and Prophylactic Cranial Irradiation in pT1-2N0M0 Stage of Small Cell Lung Cancer	NCT03514849	Small-cell Lung...	prophylactic cr... lobectomy + med... postoperative a...	18 Years -	Shanghai Pulmonary Hospital, Shanghai, China
Clinical Study of Combined Radical Operation With Postoperative Adjuvant Chemotherapy and Prophylactic Cranial Irradiation in pT1-2N0M0 Stage of Small Cell Lung Cancer	NCT03514849	Small-cell Lung...	prophylactic cr... lobectomy + med... postoperative a...	18 Years -	Shanghai Pulmonary Hospital, Shanghai, China

Spots Global Cancer Trial Database for prophylactic cranial irradiation (pci)