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

NCT02432365 | Unknown Phase 2 DMC

• 2 other identifiers: AGOG14-001/TGOG1008IRB103-4781A3
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

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).

Conditions

Cervical Cancer

Keywords

Paclitaxel; Cisplatin; Cervical cancer; Radical hysterectomy; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• 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.

  January 31, 2023 (5 years)

Secondary Outcomes (5)

• Safety (If > 6 significant G3/4 AEs occur)

  January 31, 2023 (up to 5 years)

• Response rate (Pathological response)

  Post-operative 1 month

• Postoperative RT/CRT rate

  Post-operative 6 months

• Quality-of-life

  at completion of neoadjuvant chemotherapy

• Progression-free survival

  January 31, 2023 (up to 5 years)

Study Arms (1)

Weekly paclitaxel and cisplatin

EXPERIMENTAL

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; Drug: cisplatin; Procedure: Radical hysterectomy and bilateral pelvic lymphadenectomy

Interventions

paclitaxel DRUG

7-day cycle schedule of paclitaxel (60 mg/m2)

Also known as: Taxol

Weekly paclitaxel and cisplatin

cisplatin DRUG

7-day cycle schedule of cisplatin (40 mg/m2)

Also known as: Kemoplat

Weekly paclitaxel and cisplatin

Radical hysterectomy and bilateral pelvic lymphadenectomy PROCEDURE

2 weeks after last course of neoadjuvant chemotherapy

Also known as: RH-PLND

Weekly paclitaxel and cisplatin

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Asian Gynecologic Oncology Group: collaborator
• Taiwanese Gynecologic Oncology Group: collaborator

Study Sites (5)

Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital

Chiayi City, Taiwan

RECRUITING

Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center

Taoyuan District, Taiwan

RECRUITING

Related Links

• MedlinePlus related topics
• Drug Information available for: Cisplatin
• Drug Information available for: Paclitaxel
• U.S. FDA Resources

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Huei-Jean Huang, M.D

  Gynecologic oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huei-Jean Huang, M.D

CONTACT

03-3281200; hjhuang@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: May 4, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

TW (5)