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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cisplatin
Carboplatin
Paclitaxel
Trachelectomy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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 >2 cm - ≤4 cm 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

Sites / Locations

  • MD Anderson Cancer CentreRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • L'Hôtel-Dieu de QuébecRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy

Secondary Outcome Measures

Number of side effects
By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Rate of completion of neo-adjuvant chemotherapy
Response rate following neo-adjuvant chemotherapy
By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Rate of fertility sparing surgery
Surgical complication rate following fertility sparing surgery
By Clavien-Dindo classification of surgical morbidity
Rate of recurrence-free survival
Rate of recurrence-free survival
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery

Full Information

First Posted
July 8, 2019
Last Updated
June 15, 2023
Sponsor
University Health Network, Toronto
Collaborators
Hotel Dieu Hospital, The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04016389
Brief Title
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
Acronym
CoNteSSa
Official Title
FIGO 2018 Stage IB2 (> 2 to ≤4cm) Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Hotel Dieu Hospital, The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
Intervention Type
Procedure
Intervention Name(s)
Trachelectomy
Intervention Description
Surgery to remove the cervix but keep the uterus intact.
Primary Outcome Measure Information:
Title
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of side effects
Description
By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
2 years
Title
Rate of completion of neo-adjuvant chemotherapy
Time Frame
2 years
Title
Response rate following neo-adjuvant chemotherapy
Description
By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame
2 years
Title
Rate of fertility sparing surgery
Time Frame
2 years
Title
Surgical complication rate following fertility sparing surgery
Description
By Clavien-Dindo classification of surgical morbidity
Time Frame
2 years
Title
Rate of recurrence-free survival
Time Frame
2 years
Title
Rate of recurrence-free survival
Time Frame
3 years
Title
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Time Frame
2 years
Title
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 >2 cm - ≤4 cm 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Lheureux, M.D.
Phone
416-946-2818
Email
stephanie.lheureux@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Lheureux, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Centre
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Cobb, MD
Phone
713-745-8511
Email
lpcobb@mdanderson.org
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Lheureux, M.D.
Phone
416-946-2818
Email
stephanie.lheureux@uhn.ca
Facility Name
L'Hôtel-Dieu de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Plante, M.D.
Email
Marie.Plante@crchudequebec.ulaval.ca

12. IPD Sharing Statement

Learn more about this trial

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

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