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

October 27, 2017 updated by: Huei-Jean Huang, Chang Gung Memorial Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Chiayi City, Taiwan
        • Recruiting
        • Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Chih-Wen Tseng, M.D.
      • Kaohsiung, Taiwan
        • Recruiting
        • Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Hong-Jun Fu, M.D.
      • Taichung, Taiwan
        • Recruiting
        • Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Chih-Jen Tseng, M.D.
      • Taipei, Taiwan
        • Recruiting
        • Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jui-Der Liou, M.D.
      • Taoyuan, Taiwan
        • Recruiting
        • Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center
        • Contact:
        • Principal Investigator:
          • Huei-Jean Huang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: paclitaxel
7-day cycle schedule of paclitaxel (60 mg/m2)
Other Names:
  • Taxol
Drug: cisplatin
7-day cycle schedule of cisplatin (40 mg/m2)
Other Names:
  • Kemoplat
Procedure: Radical hysterectomy and bilateral pelvic lymphadenectomy
2 weeks after last course of neoadjuvant chemotherapy
Other Names:
  • RH-PLND

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survivial
Time Frame: January 31, 2023 (5 years)
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.
January 31, 2023 (5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (If > 6 significant G3/4 AEs occur)
Time Frame: January 31, 2023 (up to 5 years)
If > 6 significant G3/4 AEs occur
January 31, 2023 (up to 5 years)
Response rate (Pathological response)
Time Frame: Post-operative 1 month
Pathological response will be calculated
Post-operative 1 month
Postoperative RT/CRT rate
Time Frame: Post-operative 6 months
Postoperative RT/CCRT will be given to defined high-risk group
Post-operative 6 months
Quality-of-life
Time Frame: at completion of neoadjuvant chemotherapy
using EORTC QLQ-C30, EORTC-QLQ-CX24
at completion of neoadjuvant chemotherapy
Progression-free survival
Time Frame: January 31, 2023 (up to 5 years)
PFS will be evaluated using Kaplan-Meier method
January 31, 2023 (up to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Asian Gynecologic Oncology Group
Taiwanese Gynecologic Oncology Group

Investigators

  • Principal Investigator: Huei-Jean Huang, M.D, Gynecologic Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGOG14-001/TGOG1008
  • IRB103-4781A3 (Other Identifier: Chang Gung Memorial Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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