Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
NCT ID: NCT02432365
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
64 participants
INTERVENTIONAL
2015-02-28
2023-12-31
Brief Summary
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Detailed Description
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Primary Objectives:
• Overall survival
Secondary Objectives:
* Safety
* Progression-free survival
* Response rate
* Postoperative RT/CRT rate
* To assess Quality-of-life
An estimate of 64 evaluable patients will be enrolled in this phase II investigation.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Weekly paclitaxel and cisplatin
7-day cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen followed by radical hysterectomy and bilateral pelvic lymphadenectomy
paclitaxel
7-day cycle schedule of paclitaxel (60 mg/m2)
cisplatin
7-day cycle schedule of cisplatin (40 mg/m2)
Radical hysterectomy and bilateral pelvic lymphadenectomy
2 weeks after last course of neoadjuvant chemotherapy
Interventions
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paclitaxel
7-day cycle schedule of paclitaxel (60 mg/m2)
cisplatin
7-day cycle schedule of cisplatin (40 mg/m2)
Radical hysterectomy and bilateral pelvic lymphadenectomy
2 weeks after last course of neoadjuvant chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HPV16-positive aged 35-70 years or HPV16-negative age \<55 years
3. FIGO stage IB2 or bulky IIA, with tumor extending to the vagina within the upper one third of the vaginal wall. Bulky tumor is defined as
1. a visible cervical tumor with the largest diameter \>4 cm or (b) a cervix expanded to \> 4 cm as a result of tumor infiltration by pelvic examination
2. verified by magnetic resonance image (MRI) or 3-dimensional (D) computed tomography (CT)
4. no suspicious extrapelvic metastasis detected by MRI or 3-D CT
5. adequate marrow, liver and renal functions :hemoglobin level \>= 10 g/dL, WBC count \>= 3,000/mm3 or absolute neutrophil count \>= 1,500/mm3, platelet count \>= 100,000/mm3, serum transaminase (AST, ALT) levels \<= 60 IU/mL, total serum bilirubin within normal range, serum creatinine level \<= 1.5 mg/dL, and blood urea nitrogen level \<=20 mg/dL
6. adequate cardiopulmonary function that tolerates the administration of study regimen and radical hysterectomy
7. Eastern Cooperative Oncology Group performance status of 0 to 1
8. had written informed consent to participate in the study
9. Appropriate organ and marrow function :
leukocytes \>=3,000/μL absolute neutrophil count \>= 1,500/μL platelets \>= 100,000/μL (not platelet transfusion dependent) hemoglobin \>= 10 g/dL total bilirubin within normal range AST/ALT \<= 2.5 X upper limit of normal range (ULN) BUN \<= 20 mg/dL serum creatinine \<=1.5 mg/dL or clearance \> 60 mL/min
10. a negative urinary pregnancy test in a patient with child-bearing potential
Exclusion Criteria
1. adenocarcinoma , adenosquamous carcinoma, or small cell carcinoma
2. concurrent or history of malignant tumor(s) other than treated nonmelanoma skin cancer
3. had received surgical procedure other than cervical biopsy or cytotoxic procedure including chemotherapy, radiotherapy or therapy with biologic response modifier(s) for the cervical tumor
4. enlarged pelvic lymph node with positive aspiration cytologic or histologic study
5. participate in investigational treatment or another clinical trial for cervical cancer
6. history of allergic reaction to platinum or paclitaxel
7. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
8. pregnant or breast feeding women
35 Years
70 Years
FEMALE
Yes
Sponsors
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Asian Gynecologic Oncology Group
OTHER
Taiwanese Gynecologic Oncology Group
UNKNOWN
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Huei-Jean Huang
MD
Principal Investigators
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Huei-Jean Huang, M.D
Role: PRINCIPAL_INVESTIGATOR
Gynecologic oncology
Locations
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Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Chiayi City, , Taiwan
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital
Taichung, , Taiwan
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Taipei, , Taiwan
Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chih-Wen Tseng, M.D.
Role: primary
Hung-Chun Fu, M.D.
Role: primary
Chih-Jen Tseng, M.D.
Role: primary
Jui-Der Liou, M.D.
Role: primary
Huei-Jean Huang, M.D.
Role: primary
Related Links
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MedlinePlus related topics
Drug Information available for: Cisplatin
Drug Information available for: Paclitaxel
U.S. FDA Resources
Other Identifiers
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IRB103-4781A3
Identifier Type: OTHER
Identifier Source: secondary_id
AGOG14-001/TGOG1008
Identifier Type: -
Identifier Source: org_study_id