Cervical Cancer Stage IVB Clinical Trial
Official title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial
This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma ) 2. KPS=70 3. FIGO stage IVB 4. Age: 18-70 5. ECOG (Eastern Cooperative Oncology Group) : 0-2 6. The expected survival time is >6 months 7. Chemotherapy and radiation have not been done before 8. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin=90g/l, normal liver/kidney function) 9. Able to understand this study and have signed informed consent. Exclusion Criteria: 1. Prior hysterectomy 2. Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm 3. Patients with brain metastasis or disseminated peritoneal metastasis 4. Female in pregnancy or lactating 5. Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy) 6. History of major psychiatric disorder 7. Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct 8. Patient with any other disease or condition is a contraindication for chemoradiotherapy 9. The researchers consider the patient not appropriate to be enrolled |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival time, PFS | Progression-free survival will be evaluated | 2 years | |
Secondary | Number of Patients with Adverse Events as a Measure of Safety | To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity | 2 years | |
Secondary | Objective Response Rates, ORR | Objective Response Rates will be evaluated | 2 years | |
Secondary | Overall survival | Overall survival will be evaluated | 2 years | |
Secondary | Ranking Quality of Life of Patients | To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and cervical cancer module(CX24). | 2 years | |
Secondary | Screening for potentially curable primary stage IVB cervical cancer | By follow-up data,screening for potentially curable primary stage IVB cervical cancer | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT03146039 -
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB
|
Phase 2 | |
Completed |
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N/A |