NCT07819669Toborzás még nem indult
Video-Assisted Thoracoscopic Surgery Combined With Radiofrequency Ablation Versus VATS Alone for Multiple Primary Lung Cancer
A Multicenter Randomized Controlled Trial of Video-Assisted Thoracoscopic Resection Combined With Intraoperative Radiofrequency Ablation Versus Video-Assisted Thoracoscopic Resection Alone for Synchronous Multiple Primary Lung Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 15.
Rövid összefoglaló (regiszter, angolul)
This multicenter randomized controlled trial will compare two surgical approaches for patients with synchronous ipsilateral multiple primary lung cancer, meaning two or more primary lung cancers diagnosed at the same time in the same lung. The study aims to determine whether combining thoracoscopic resection with radiofrequency ablation can preserve more lung function while maintaining acceptable tumor control and safety compared with thoracoscopic resection alone. A total of 160 participants will be randomly assigned in a 1:1 ratio to one of two groups. In the combined-treatment group, the main lung lesion will be removed by video-assisted thoracoscopic surgery, and the secondary lesion will be treated with intraoperative computed tomography-guided radiofrequency ablation. In the surgery-alone group, both the main and secondary lesions will be removed by video-assisted thoracoscopic surgery. The primary outcome is the change in forced expiratory volume in one second (FEV1), a standard measure of lung function, from baseline to 6 months after surgery. Other outcomes include local recurrence, treatment-related complications, disease-free and overall survival, length of hospital stay, medical costs, quality of life, patient satisfaction, and the change in postoperative lung volume compared with preoperative lung volume, as quantitatively measured using three-dimensional chest computed tomography reconstruction. Participants will be followed at approximately 1, 3, 6, 12, and 24 months after surgery.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 160 (tervezett)
- Első benyújtás
- 2026. aug. 9.
- Kezdés
- 2026. szept.
- Elsődleges befejezés
- 2029. febr.
- Fő szponzor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07819669
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 160
- 2026. szept. és az elsődleges befejezés (2029. febr.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Previous pulmonary surgery.
Más betegség
- Distant metastatic disease or N2 or N3 lymph node involvement.
- Severe cardiac or pulmonary dysfunction that would preclude the planned surgery, anesthesia, or radiofrequency ablation.
- Active bleeding disorder or severe coagulation abnormality.
- Uncontrolled pulmonary infection or active pulmonary tuberculosis.
Egyéb
- Pregnancy or breastfeeding.
- The secondary lesion cannot be safely accessed using the intraoperative CT-guided radiofrequency ablation system.
- The secondary lesion is adjacent to a major blood vessel or another critical structure such that radiofrequency ablation is considered unsafe or unsuitable.
Kiket keres a vizsgálat
- Age 18 to 80 years, inclusive.
- Diagnosis of synchronous ipsilateral multiple primary lung cancer based on imaging and/or biopsy findings and confirmed by a multidisciplinary team.
- The main lesion is considered suitable for video-assisted thoracoscopic lobectomy or sublobar resection, with complete resection anticipated.
- The secondary lesion is considered suitable for both video-assisted thoracoscopic sublobar resection and intraoperative CT-guided radiofrequency ablation.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Preoperative forced expiratory volume in 1 second of at least 50% of the predicted value.
- Ability to understand the study requirements and willingness to provide written informed consent.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical | Beijing | Kína | Ismeretlen állapot |
| National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Shenzhen | Kína | Ismeretlen állapot |
| Shanxi Province Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University | Taiyuan | Kína | Ismeretlen állapot |
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