NSCLC Clinical Trial
Official title:
Phase II Trial of Stereotactic Body Radiation Therapy Compared With Conventional Fractionated Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer
This protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of SBRT compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell Lung Cancer
Non small-cell lung cancer (NSCLC) is the leading cause of cancer-related death worldwide.
Approximately half of all patients with NSCLC present with metastatic disease at the time of
diagnosis, and the predominant pattern of failure in patients with localized NSCLC is
distant metastatic spread. The standard treatment in metastatic disease is cytotoxic
chemotherapy with a mean overall survival between 8-11 months.
Various studies suggest that patients who clinically present with a limited number of
metastases, a term defined as oligometastatic disease, could have a better prognosis of
survival with a radical treatment, than for their counterparts with a greater number of
metastasis. Much of the current clinical outcomes in oligometastatic disease is based on a
series of the retrospective studies.
This is a randomised prospective phase II study based on patients with stage IV
oligometastatic NSCLC according to UICC stage system(version 7,2009) or oligometastatic
disease after radical operation for stage I-III NSCLC. The purpose of this study is to add
more information to the current medical literature about the efficacy and safety of
Stereotactic Body Radiation Therapy (SBRT) compared with conventional fractionated
radiotherapy for oligometastatic non-small cell lung cancer (equal to or less than 5 sites
and equal to or less than 5cm in maximum diameter).
The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet
chemotherapy), and achieve response(stable disease or partial response or complete
response). Patients will be randomized into two groups. The control group will undergo the
conventional fractionated radiotherapy to all metastatic sites and the primary tumor. The
experimental group will receive SBRT to primary lesions or metastatic lesions.
The investigators will compare progress free survival(PFS) ,overall survival, incidence of
treatment-related adverse events of the two groups.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05821933 -
RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03269162 -
Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection
|
Phase 3 | |
| Recruiting |
NCT05002270 -
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06315686 -
The Dynamic Monitoring of Cerebrospinal Fluid ctDNA
|
Phase 2 | |
| Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
| Recruiting |
NCT05466149 -
Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
|
Phase 2 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Completed |
NCT03609918 -
Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
|
||
| Recruiting |
NCT06043817 -
First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
|
Phase 1/Phase 2 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05078931 -
A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients
|
Phase 2 | |
| Not yet recruiting |
NCT05547737 -
Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
|
||
| Not yet recruiting |
NCT05909137 -
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
|
||
| Withdrawn |
NCT05959473 -
EGFR_IUO 3.20 Clinical Study Protocol
|
N/A | |
| Not yet recruiting |
NCT05005468 -
A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC.
|
Phase 2 | |
| Recruiting |
NCT01690390 -
Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
|
Phase 2 | |
| Completed |
NCT01852578 -
Cabazitaxel in Relapsed and Metastatic NSCLC
|
Phase 2 | |
| Active, not recruiting |
NCT01460472 -
Immunotherapy With Racotumomab in Advanced Lung Cancer
|
Phase 3 | |
| Completed |
NCT00702975 -
Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
|
Phase 2 | |
| Completed |
NCT00866970 -
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
|
Phase 2 |