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Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
paclitaxel
cisplatin
Radical hysterectomy and bilateral pelvic lymphadenectomy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Paclitaxel, Cisplatin, Cervical cancer, Radical hysterectomy, Neoadjuvant

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women with previously untreated, histologically confirmed squamous cell carcinoma of the uterine cervix
  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:

Patients will be excluded from the study if they meet any of the following 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

Sites / Locations

  • Department of Obstetrics & Gynecology, Chang Gung Memorial HospitalRecruiting
  • Department of Obstetrics & Gynecology, Chang Gung Memorial HospitalRecruiting
  • Department of Obstetrics and Gynecology, Chung Shan Medical University HospitalRecruiting
  • Department of Obstetrics & Gynecology, Chang Gung Memorial HospitalRecruiting
  • Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weekly paclitaxel and cisplatin

Arm Description

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

Outcomes

Primary Outcome Measures

overall survivial
The primary objective is to determinate the difference in 5-year survival rate of subjects with NAC+RH-PLND compared with standard CCRT. Based on the pilot research, the 5-year survival rate of NAC+RH-PLND is expected to be around 87.5%. Thus, a sample size of 64 subjects in NAC+RH-PLND group is required for correctly detecting a 12.5% difference between 5-year OS rate of NAC+RH-PLND group and a reference value 75% of standard CCRT in order to achieving an 80% power at a significance level 0.05.

Secondary Outcome Measures

Safety (If > 6 significant G3/4 AEs occur)
If > 6 significant G3/4 AEs occur
Response rate (Pathological response)
Pathological response will be calculated
Postoperative RT/CRT rate
Postoperative RT/CCRT will be given to defined high-risk group
Quality-of-life
using EORTC QLQ-C30, EORTC-QLQ-CX24
Progression-free survival
PFS will be evaluated using Kaplan-Meier method

Full Information

First Posted
February 10, 2015
Last Updated
October 27, 2017
Sponsor
Chang Gung Memorial Hospital
Collaborators
Asian Gynecologic Oncology Group, Taiwanese Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02432365
Brief Title
Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
Official Title
Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Asian Gynecologic Oncology Group, Taiwanese Gynecologic Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose was to establish a quick (7-day) cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen could be tolerated without interfering the following surgical treatment and a favorable overall survival rate for stages IB2 and IIA2 cervical squamous cell carcinoma (SCC).
Detailed Description
This is a multi-center, open-label, Simon's 2-stage, phase II study of paclitaxel and cisplatin as neoadjuvant therapy in patients with FIGO IB2 or IIA2, squamous cell cervical carcinoma of the uterine cervix. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Paclitaxel, Cisplatin, Cervical cancer, Radical hysterectomy, Neoadjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weekly paclitaxel and cisplatin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
7-day cycle schedule of paclitaxel (60 mg/m2)
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Kemoplat
Intervention Description
7-day cycle schedule of cisplatin (40 mg/m2)
Intervention Type
Procedure
Intervention Name(s)
Radical hysterectomy and bilateral pelvic lymphadenectomy
Other Intervention Name(s)
RH-PLND
Intervention Description
2 weeks after last course of neoadjuvant chemotherapy
Primary Outcome Measure Information:
Title
overall survivial
Description
The primary objective is to determinate the difference in 5-year survival rate of subjects with NAC+RH-PLND compared with standard CCRT. Based on the pilot research, the 5-year survival rate of NAC+RH-PLND is expected to be around 87.5%. Thus, a sample size of 64 subjects in NAC+RH-PLND group is required for correctly detecting a 12.5% difference between 5-year OS rate of NAC+RH-PLND group and a reference value 75% of standard CCRT in order to achieving an 80% power at a significance level 0.05.
Time Frame
January 31, 2023 (5 years)
Secondary Outcome Measure Information:
Title
Safety (If > 6 significant G3/4 AEs occur)
Description
If > 6 significant G3/4 AEs occur
Time Frame
January 31, 2023 (up to 5 years)
Title
Response rate (Pathological response)
Description
Pathological response will be calculated
Time Frame
Post-operative 1 month
Title
Postoperative RT/CRT rate
Description
Postoperative RT/CCRT will be given to defined high-risk group
Time Frame
Post-operative 6 months
Title
Quality-of-life
Description
using EORTC QLQ-C30, EORTC-QLQ-CX24
Time Frame
at completion of neoadjuvant chemotherapy
Title
Progression-free survival
Description
PFS will be evaluated using Kaplan-Meier method
Time Frame
January 31, 2023 (up to 5 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with previously untreated, histologically confirmed squamous cell carcinoma of the uterine cervix HPV16-positive aged 35-70 years or HPV16-negative age <55 years 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 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 verified by magnetic resonance image (MRI) or 3-dimensional (D) computed tomography (CT) no suspicious extrapelvic metastasis detected by MRI or 3-D CT 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 adequate cardiopulmonary function that tolerates the administration of study regimen and radical hysterectomy Eastern Cooperative Oncology Group performance status of 0 to 1 had written informed consent to participate in the study 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 a negative urinary pregnancy test in a patient with child-bearing potential Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria: adenocarcinoma , adenosquamous carcinoma, or small cell carcinoma concurrent or history of malignant tumor(s) other than treated nonmelanoma skin cancer 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 enlarged pelvic lymph node with positive aspiration cytologic or histologic study participate in investigational treatment or another clinical trial for cervical cancer history of allergic reaction to platinum or paclitaxel 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 pregnant or breast feeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huei-Jean Huang, M.D
Phone
03-3281200
Ext
8984
Email
hjhuang@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huei-Jean Huang, M.D
Organizational Affiliation
Gynecologic oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
City
Chiayi City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Wen Tseng, M.D.
Email
otcwwell@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Chih-Wen Tseng, M.D.
Facility Name
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Chun Fu, M.D.
Phone
886-7-731-7123
Ext
8916
Email
allen133@adm.cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Hong-Jun Fu, M.D.
Facility Name
Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Jen Tseng, M.D.
Phone
886-4-24739595
Ext
34121
Email
obgyntw@gmail.com
First Name & Middle Initial & Last Name & Degree
Chih-Jen Tseng, M.D.
Facility Name
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jui-Der Liou, M.D.
Phone
886-2-27135211
Ext
3345
Email
liou88@ms13.hinet.net
First Name & Middle Initial & Last Name & Degree
Jui-Der Liou, M.D.
Facility Name
Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huei-Jean Huang, M.D.
Email
hueijean.huang@gmail.com
First Name & Middle Initial & Last Name & Degree
Huei-Jean Huang, M.D.

12. IPD Sharing Statement

Links:
URL
https://medlineplus.gov/hysterectomy.html
Description
MedlinePlus related topics
URL
http://druginfo.nlm.nih.gov/drugportal/name/Cisplatin
Description
Drug Information available for: Cisplatin
URL
https://druginfo.nlm.nih.gov/drugportal/name/Paclitaxel
Description
Drug Information available for: Paclitaxel
URL
https://clinicaltrials.gov/ct2/info/fdalinks
Description
U.S. FDA Resources

Learn more about this trial

Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy

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