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FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016389
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : September 30, 2021
Sponsor:
Collaborators:
Hotel Dieu Hospital
The Netherlands Cancer Institute
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date September 30, 2021
Actual Study Start Date  ICMJE February 11, 2020
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Number of side effects [ Time Frame: 2 years ]
    By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • Rate of completion of neo-adjuvant chemotherapy [ Time Frame: 2 years ]
  • Response rate following neo-adjuvant chemotherapy [ Time Frame: 2 years ]
    By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Rate of fertility sparing surgery [ Time Frame: 2 years ]
  • Surgical complication rate following fertility sparing surgery [ Time Frame: 2 years ]
    By Clavien-Dindo classification of surgical morbidity
  • Rate of recurrence-free survival [ Time Frame: 2 years ]
  • Rate of recurrence-free survival [ Time Frame: 3 years ]
  • Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery [ Time Frame: 2 years ]
  • Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
Official Title  ICMJE FIGO 2018 Stage IB2 (≥2 to <4 cm) Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Brief Summary

This study will include patients with invasive cervical cancer that wish to keep their fertility as much as possible in the future after treatment.

Patients who receive surgery alone may experience long-term side effects including infertility. The purpose of this research study is to determine whether giving neo-adjuvant chemotherapy prior to surgery can maintain fertility in patients with invasive cervical cancer.

The neo-adjuvant chemotherapy will consist of a platinum-based chemotherapy drug cisplatin or carboplatin, with a chemotherapy drug called paclitaxel. These are common chemotherapy drugs used in the treatment of women with cervical cancers.

Detailed Description

All participants will first receive neo-adjuvant platinum-based chemotherapy. Once the neo-adjuvant chemotherapy has been completed, participants will be assessed by imaging scans to see whether they have a response to the treatment.

If participants are responding to treatment, they will then have a trachelectomy. After surgery, participants will be assessed and the study doctor will determine whether adjuvant treatment is needed. Adjuvant treatment may include chemotherapy and radiotherapy, or have a hysterectomy done.

If participants do not respond to or their disease worsens after neo-adjuvant treatment, participants will receive adjuvant treatment with chemotherapy and radiotherapy or have a hysterectomy done.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: Cisplatin
    Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
  • Drug: Carboplatin
    Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
  • Drug: Paclitaxel
    Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
  • Procedure: Trachelectomy
    Surgery to remove the cervix but keep the uterus intact.
Study Arms  ICMJE Experimental: Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy

Participants will receive neo-adjuvant treatment cisplatin or carboplatin with paclitaxel, intravenously, either once every cycle or once a week, for three (21-day) cycles.

After neo-adjuvant treatment, depending on their status, participants may have the trachelectomy done.

Adjuvant treatment may include standard chemotherapy and radiotherapy, or a hysterectomy may need to be done.

Interventions:
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Procedure: Trachelectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Part 1 - Eligibility Criteria for Neoadjuvant Chemotherapy

  • Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring ≥2cm to <4cm by radiological imaging (MRI).
  • Patients must be premenopausal and wish to preserve fertility.
  • At time of registration, patient may not have had any prior therapy to treat their cancer lesion.
  • Eastern Cooperative Group (ECOG) performance status ≤ 2.
  • Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function.
  • No evidence of active uncontrolled infection (patients on antibiotics are eligible).
  • Patient must have disease that is measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Ability to understand and willing to sign a written informed consent document.
  • Patients must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least one year after the fertility-sparing surgery (FSS) procedure. A serum pregnancy test within 72 hours prior to study registration is required.

Part 2 - Eligibility Criteria for Fertility Sparing Surgery (FSS)

  • Completed 3 cycles of neo-adjuvant chemotherapy and achieved a complete response (CR) or partial response (PR) with reduction of the lesion to <2 cm on physical examination and MRI.

Exclusion Criteria:

Part 1 - Exclusion Criteria for Neoadjuvant Chemotherapy

  • Patients who have had chemotherapy or radiotherapy or surgery for their cancer.
  • Patients who are receiving any other investigational agents.
  • Patients with other cancers requiring ongoing treatment.
  • Patients with known / evidence of brain metastases are excluded from participation in this clinical trial.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study.
  • Uncontrolled inter-current 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.
  • Patients who are pregnant or breastfeeding
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues.

Part 2 - Exclusion Criteria for Fertility Sparing Surgery

  • Patient unable to complete 3 cycles of neoadjuvant chemotherapy
  • Suboptimal response to neoadjuvant chemotherapy according to investigator
  • Residual lesion > 2cm or disease progression while on chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Lheureux, M.D. 416-946-2818 stephanie.lheureux@uhn.ca
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016389
Other Study ID Numbers  ICMJE 19-5443
CoNteSSa - NeoCon ( Other Identifier: Princess Margaret Cancer Centre )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Hotel Dieu Hospital
  • The Netherlands Cancer Institute
Investigators  ICMJE
Principal Investigator: Stephanie Lheureux, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP