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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Fudan University | OTHER |
| Xijing Hospital | OTHER |
| Henan Cancer Hospital |
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This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. In order to establish whether the SIB technique can improve the results of twice-daily chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB twice-daily RT or standard dose twice-daily RT.
Three hundred and twenty-six patients with a histological or cytological proven diagnosis of SCLC will be recruited from 35 centers in 14 areas including provinces, municipalities and autonomous region, from May 2017 to May 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIB group | Experimental | Patients in this group will receive concurrent twice-daily radiotherapy by SIB technique (95%PGTV 54Gy, 95%PTV 45Gy,both in 30 twice-daily fractions over 3 weeks, 5 days per week) and chemotherapy (etoposide and cisplatin). |
|
| BID group | Active Comparator | Patients in this group will receive concurrent twice-daily standard radiotherapy (95%PTV 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per week, without SIB) and chemotherapy (etoposide and cisplatin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIB | Radiation | patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from the starting date of treatment until the date of death from any cause | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local Progression Free Survival | from the starting date of treatment until the date of local disease progression | 5 years |
| Metastasis Free Survival | from the staring date of treatment until the date of distant metastasis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anhui Shi, Doctor | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39146944 | Derived | Yu J, Jiang L, Zhao L, Yang X, Wang X, Yang D, Zhuo M, Chen H, Huang W, Zhu Z, Zhang M, Song Y, Li Q, Ma Z, Wang Q, Qu Y, Yu R, Yu H, Zhao J, Shi A; Trial Management Group. High-dose hyperfractionated simultaneous integrated boost radiotherapy versus standard-dose radiotherapy for limited-stage small-cell lung cancer in China: a multicentre, open-label, randomised, phase 3 trial. Lancet Respir Med. 2024 Oct;12(10):799-809. doi: 10.1016/S2213-2600(24)00189-9. Epub 2024 Aug 12. |
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undecided
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
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| OTHER_GOV |
| Jilin Provincial Tumor Hospital | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Air Force General Hospital of the PLA | OTHER_GOV |
| China-Japan Friendship Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Beijing Chao Yang Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Peking University First Hospital | OTHER |
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| Standard | Radiation | patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy |
|
|
| 5 years |
| health related quality of life | assessed from completed questionnaires. Assessments using Physicians Global Assessment to measure quality of life. | from baseline, immediately after radiotherapy and an average of 3 months up to 24 months. Then through study completion, an average of 6 months.From date of randomization until the date of death from any cause, assessed up to 120 months. |
| acute and late toxicity | acute toxicity (defined as toxicity occurring between the start of treatment and up to 3 months after completion of treatment, and assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 5.0]), late toxicity (more than 3 months after completion of treatment, and assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 5.0]) | from baseline, immediately after radiotherapy and an average of 1 week up to 12 weeks, an average of 3 months up to 24 months. Up to 120 weeks. |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |