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In patients with oligometastatic (1-5 lesions) extensive-stage small cell lung cancer, to explore the efficacy and safety of Durvalumab immunotherapy combined with chemotherapy followed by consolidation radiotherapy, to provide scientific basis for the formulation of the best comprehensive treatment plan in the future.
To explore the efficacy and safety of consolidation radiotherapy after Durvalumab immunotherapy combined with chemotherapy in patients with oligometastatic small cell lung cancer (1-5 lesions), so as to provide scientific basis for making the best comprehensive treatment plan in the future.All subjects will receive the following treatments:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin | Experimental | Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab + carboplatin/cisplatin + etoposide | Drug | Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival time | Time from the date of first dosing of Durvalumab to death from any cause. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| locoregional recurrence-free survival | The time from the date of first dosing of Durvalumab to the first appearance of objective disease progression or death from any cause (if it occurs before disease progression). | up to 2 years |
| distant metastasis-free survival |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liao zhiwei | Contact | 13622876524 | vigo310@126.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32370765 | Background | Olson R, Mathews L, Liu M, Schellenberg D, Mou B, Berrang T, Harrow S, Correa RJM, Bhat V, Pai H, Mohamed I, Miller S, Schneiders F, Laba J, Wilke D, Senthi S, Louie AV, Swaminath A, Chalmers A, Gaede S, Warner A, de Gruijl TD, Allan A, Palma DA. Stereotactic ablative radiotherapy for the comprehensive treatment of 1-3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial. BMC Cancer. 2020 May 5;20(1):380. doi: 10.1186/s12885-020-06876-4. | |
| 33437660 |
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| Consolidation radiotherapy | Radiation | Consolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions. |
|
| Durvalumab | Drug | Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion |
|
The time from the date of first dosing of Durvalumab to the first appearance of the tumor had metastasized. |
| up to 2 years |
| Background |
| Mielgo-Rubio X, Garde-Noguera J, Juan O, Counago F. Stereotactic body radiation therapy: A good dance partner of oligometastatic non-small cell lung cancer to the sound of SINDAS study. World J Clin Oncol. 2020 Dec 24;11(12):983-989. doi: 10.5306/wjco.v11.i12.983. |
| 30982687 | Background | Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11. |
| 21930323 | Background | Yee D, Butts C, Reiman A, Joy A, Smylie M, Fenton D, Chu Q, Hanson J, Roa W. Clinical trial of post-chemotherapy consolidation thoracic radiotherapy for extensive-stage small cell lung cancer. Radiother Oncol. 2012 Feb;102(2):234-8. doi: 10.1016/j.radonc.2011.08.042. Epub 2011 Sep 17. |
| 31590988 | Background | Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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