Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03732482

Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases

Non Small Cell Lung Cancer Metastatic Clinical Trial

Official title:
A Phase II/III Study of Non Small Cell Lung Cancer Patient With/Without Synchronous Oral Temozolomide Capsules Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost With Hippocampus Protection

Clinical Trial Summary

With the improvement of systemic therapeutic effect(especially in the population with driver gene mutation), the incidence of brain metastases had significantly increased. Conventional Whole Brain radiotherapy(WBRT) was less effective, the stereotactic radiosurgery(SRS) technique had improve the local efficacy for 1-3 lesions, but the probability of intracranial recurrence was increased, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost(SIB-IMRT) is a new radiotherapy technology, Giving a standard radiation dose of whole brain ,at the same time can boost the high-risk region in target, So that it can significantly shorten the treatment time, at the same time can improve the local control rate of brain metastases. In the aspect of normal tissue protecting, SIB was better than WBRT plus SRS sequential treatment pattern. 30Gy to the whole brain had a negative effects on cognitive function, the investigators previous study found that 25Gy to the whole brain while the tumor bed Simultaneous push to 50Gy was safe and effective, while reducing the impact on cognitive function. Hippocampus is a part of the brain located in the temporal lobe, Mainly responsible for long-term memory storage conversion and orientation. Many investigators point out that hippocampus is the main commander of neurocognitive function, Reduce the dose of hippocampus can significant improve the neurocognitive function. Temozolomide capsule is an anti-tumor alkylation agent for glioblastoma multiforme and anaplastic astrocytoma. In recent years, some researchers find that Temozolomide capsules combine with radiotherapy such as SRS, WBRT or The two combined, can improve Objective response(OR) and prolong the Progress Free Survival(PFS),while with tolerable therapeutic toxicity. In order to better reduce the impact on cognitive function and improve the local control rate, the investigators present this trial, under the SIB-IMRT technique, the investigators want to explore the effect of temozolomide in brain metastasis of non-small cell lung cancer with the hippocampal protection technology.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03732482
Study type Interventional
Source Taizhou Hospital
Contact Haihua Yang, MD
Phone 13819639006
Email yhh93181@hotmail.com
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date March 1, 2019
Completion date May 30, 2022
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03168464 - Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632) Phase 1/Phase 2
Recruiting NCT05117242 - Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer Phase 2
Completed NCT04470440 - Thyroid Dysfunction and Nivolumab Reponse in NSCLC
Completed NCT03304093 - Immunotherapy by Nivolumab for HIV+ Patients Phase 2
Terminated NCT04069936 - Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC Phase 2
Active, not recruiting NCT03307785 - Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 Phase 1
Recruiting NCT06100796 - Effect of DM on Outcomes and Response Rate in Patients With Advanced NSCLC on ICI
Recruiting NCT03533127 - A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer Phase 3
Completed NCT04187768 - Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer
Active, not recruiting NCT04951583 - Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma Phase 2
Active, not recruiting NCT03133546 - Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (BOOSTER) Phase 2
Completed NCT03845270 - Her2-positive Lung Cancer Treated With Dedicated Drug Phase 2
Recruiting NCT05864794 - Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer N/A
Recruiting NCT05274451 - A Study to Investigate LYL797 in Adults With Solid Tumors Phase 1
Recruiting NCT03774732 - PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer Phase 3
Recruiting NCT04621188 - Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) Phase 2
Recruiting NCT06378892 - A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib Phase 2
Active, not recruiting NCT03235765 - Cancer Panel From Blood of Lung Cancer Patients
Active, not recruiting NCT02978404 - Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases Phase 2
Recruiting NCT05853887 - Liquid Biopsy Based NGS in Newly Diagnosed NSCLC N/A