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| ID | Type | Description | Link |
|---|---|---|---|
| FAHGuangzhou012 | Registry Identifier | FAHGuangzhou012 |
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At present, there is no standard second-line treatment of refractory and relapsed SCLC, topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide second-line treatment of small cell lung cancer currently being explored, Anthracycline antibiotics is a cell cycle non-specific anticancer drugs could inhibit the synthesis of DNA, DNA and dependent RNA, its wide antitumor spectrum, widely used in malignant hematologic diseases and lung cancer and other solid tumors. Jacot W, et al evaluated epirubicin combined with ifosfamide (EI) for treatment of refractory and recurrent SCLC in 70 cases, the objective response rate (ORR) reached 21.4%, including 1 cases of complete remission, 10% other patients obtained stable disease (SD), all the patients had a median survival of 3.9 months, most (71%) patients with neutropenia, platelet count and anemia are also common, showed that EI treatment of refractory and relapsed SCLC is effectively controlled, toxicity.
In view of epirubicin combined with ifosfamide (EI) scheme is effective and safety in the treatment of refractory and relapsed SCLC, the investigators will use liposomal doxorubicin plus ifosfamide second-line treatment of refractory and relapsed small cell lung cancer, may obtain better tumor remission rate, improve the prognosis of the patients.
the investigators will evaluate the overall response rate (complete and partial responses) in first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal doxorubicin and ifosfamide We will evaluate the progression-free survival (PFS) and overall survival (OS) i in receiving first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal doxorubicin and ifosfamide
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractory and relapsed SCLC | Experimental | Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Doxorubicin Combined With ifosfamide | Device | Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | participants will be followed for the duration of hospital stay, an expected average of 5 months | From date of randomization until the date of progression, assessed up to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival(PFS) | From date of randomization until the date of progression, assessed up to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From date of randomization until the date of death from any cause, assessed up to 10 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianxing He, MD | Contact | +86-20-83062808 | hejx@vip.163.com | |
| yalei Zhang, Master degree | Contact | +86-20-83062821 | yayazhang2004@163.com |
| Name | Affiliation | Role |
|---|---|---|
| jianxing He, MD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| he First Affiliated Hospital of Guangzhou Medical College | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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