Cervical CancerPhase 2NCT02432365
Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
A Phase 2 study testing paclitaxel, cisplatin and Radical hysterectomy and bilateral pelvic lymphadenectomy in people with Cervical Cancer, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- paclitaxel, cisplatin and Radical hysterectomy and bilateral pelvic lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesTaiwan
- Study dates
- Feb 2015to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Chiayi City
Chih-Wen Tseng, M.D., otcwwell@cgmh.org.tw
Chih-Wen Tseng, M.D.
- Recruiting
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Kaohsiung City
Hung-Chun Fu, M.D., 886-7-731-7123 ext. 8916, allen133@adm.cgmh.org.tw
Hong-Jun Fu, M.D.
- Recruiting
Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital
Taichung
Chih-Jen Tseng, M.D., 886-4-24739595 ext. 34121, obgyntw@gmail.com
Chih-Jen Tseng, M.D.
- Recruiting
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Taipei
Jui-Der Liou, M.D., 886-2-27135211 ext. 3345, liou88@ms13.hinet.net
Jui-Der Liou, M.D.
- Recruiting
Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center
Taoyuan
Huei-Jean Huang, M.D., hueijean.huang@gmail.com
Huei-Jean Huang, M.D.
About this study
Official title: 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).
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- paclitaxel, cisplatin, Radical hysterectomy and bilateral pelvic lymphadenectomy
- Keywords
- Paclitaxel, Cisplatin, Cervical cancer, Radical hysterectomy, Neoadjuvant
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Also called Taxol
7-day cycle schedule of paclitaxel (60 mg/m2)
cisplatinDrug
Also called Kemoplat
7-day cycle schedule of cisplatin (40 mg/m2)
Radical hysterectomy and bilateral pelvic lymphadenectomyProcedure or surgery
Also called RH-PLND
2 weeks after last course of neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: paclitaxel; Drug: cisplatin; Procedure: Radical hysterectomy and bilateral pelvic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 31, 2023 (5 years)
Secondary outcomes (5)
Safety (If > 6 significant G3/4 AEs occur)
If > 6 significant G3/4 AEs occur
Measured: January 31, 2023 (up to 5 years)
Response rate (Pathological response)
Pathological response will be calculated
Measured: Post-operative 1 month
Postoperative RT/CRT rate
Postoperative RT/CCRT will be given to defined high-risk group
Measured: Post-operative 6 months
Quality-of-life
using EORTC QLQ-C30, EORTC-QLQ-CX24
Measured: at completion of neoadjuvant chemotherapy
Progression-free survival
PFS will be evaluated using Kaplan-Meier method
Measured: January 31, 2023 (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asian Gynecologic Oncology Group, Taiwanese Gynecologic Oncology Group
- Responsible party
- Principal investigator, Huei-Jean Huang, Chang Gung Memorial Hospital
- Investigators
- Huei-Jean Huang, M.D, Principal investigator, Gynecologic oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432365
- Sponsor's protocol ID
- AGOG14-001/TGOG1008
- Other IDs
- IRB103-4781A3
- Status last verified
- Oct 2017
- First submitted
- 10 Feb 2015
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
- ClinicalTrials.gov ID
- NCT02432365
- Acronym / sponsor ID
- AGOG14-001/TGOG1008
- Conditions
- Cervical Cancer
- Keywords
- Paclitaxel, Cisplatin, Cervical cancer, Radical hysterectomy, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Asian Gynecologic Oncology Group, Taiwanese Gynecologic Oncology Group
- Study start
- Feb 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weekly paclitaxel and cisplatin | Experimental | Drug: paclitaxel, Drug: cisplatin, Procedure: Radical hysterectomy and bilateral pelvic lymphadenectomy7-day cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen followed by radical hysterectomy and bilateral pelvic lymphadenectomy |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxelAlso: Taxol7-day cycle schedule of paclitaxel (60 mg/m2) | Drug | Weekly paclitaxel and cisplatin |
| cisplatinAlso: Kemoplat7-day cycle schedule of cisplatin (40 mg/m2) | Drug | Weekly paclitaxel and cisplatin |
| Radical hysterectomy and bilateral pelvic lymphadenectomyAlso: RH-PLND2 weeks after last course of neoadjuvant chemotherapy | Procedure or surgery | Weekly paclitaxel and cisplatin |
Primary outcome
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.
5 secondary outcomes
Safety (If > 6 significant G3/4 AEs occur)
Time frame: January 31, 2023 (up to 5 years)
Response rate (Pathological response)
Time frame: Post-operative 1 month
Postoperative RT/CRT rate
Time frame: Post-operative 6 months
Quality-of-life
Time frame: at completion of neoadjuvant chemotherapy
Progression-free survival
Time frame: January 31, 2023 (up to 5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- MedlinePlus related topicsLink provided by the sponsor.
- Drug Information available for: CisplatinLink provided by the sponsor.
- Drug Information available for: PaclitaxelLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huei-Jean Huang, M.D principal investigator
Gynecologic oncology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel, cisplatin and Radical hysterectomy and bilateral pelvic lymphadenectomy in people with Cervical Cancer, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huei-Jean Huang, M.D (03-3281200 ext. 8984, hjhuang@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survivial (time frame: January 31, 2023 (5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.