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STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer.
TRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. All the enrolled patients received chemotherapy with Anlotinib.
PRIMARY ENDPOINT: Overall survival, defined as the observed length of life from entry into the study to death from any cause or the date of last contact.
Patients with advanced (metastatic, persistent, and recurrent) cervical cancer will be recruited from Zhongda Hospital. Only patients who treated with paclitaxel plus nedaplatin will be included in the analysis. All patients receive paclitaxel (135-175mg /m^2) and nedaplatin (100 mg/m^2) infusion on day 1, and then take Anlotinib 12mg/d orally on day 7-21, every 3 weeks. Once patients reached CR or PR, Anlotinib was continued on 12mg/d maintenance therapy until disease progression or unacceptable toxicity was noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy with Anlotinib | Patients received chemotherapy with Anlotinib. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from the first day of treatment until death from any cause | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The time from the first day of treatment until disease progression or death from any cause, or as the date of the last follow-up. | Up to 3 years |
| Incidence of Adverse Events [Safety and Tolerability] |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced (metastatic, persistent, and recurrent) cervical cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Shen, MD | Contact | 025-83262742 | shenyang0924@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yang Shen, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Adverse Events were assessed according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 4.0.
| Up to 3 years |
| The average score of FACT-Cx TOI [Functional Assessment] | The HRQL instruments used in this trial were the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI), for which a higher score indicates better HRQL. | Up to 3 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |