Cervical CancerNCT04016389
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
A study testing Cisplatin, Carboplatin and Paclitaxel in people with Cervical Cancer, run by University Health Network, Toronto at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Cisplatin, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Feb 2020to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Canada3 sites, 3 recruiting
- Recruiting
L'Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6
Marie Plante, M.D., Marie.Plante@crchudequebec.ulaval.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Allan Covens, MD, 416-480-4026, al.covens@sunnybrook.ca
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Stephanie Lheureux, M.D., 416-946-2818, stephanie.lheureux@uhn.ca
United States1 site
- Terminated
MD Anderson Cancer Centre
Houston, Texas, 77030
About this study
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
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Cisplatin, Carboplatin, Paclitaxel, Trachelectomy
- 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.
CisplatinDrug
Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
CarboplatinDrug
Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
PaclitaxelDrug
Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
TrachelectomyProcedure or surgery
Surgery to remove the cervix but keep the uterus intact.
| Study group | Role | What they receive |
|---|---|---|
| Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy | Experimental | 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. Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Trachelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
Measured: 2 years
Secondary outcomes (9)
Number of side effects
By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Rate of completion of neo-adjuvant chemotherapy
Measured: 2 years
Response rate following neo-adjuvant chemotherapy
By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: 2 years
Rate of fertility sparing surgery
Measured: 2 years
Surgical complication rate following fertility sparing surgery
By Clavien-Dindo classification of surgical morbidity
Measured: 2 years
Rate of recurrence-free survival
Measured: 2 years
Rate of recurrence-free survival
Measured: 3 years
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Measured: 2 years
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start11 Feb 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (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 University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hotel Dieu Hospital, The Netherlands Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Stephanie Lheureux, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016389
- Sponsor's protocol ID
- CoNteSSa
- Other IDs
- CoNteSSa - NeoCon
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2019
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04016389
- Acronym / sponsor ID
- CoNteSSa
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Hotel Dieu Hospital, The Netherlands Cancer Institute
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Jul 2019 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy | Experimental | Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel, Procedure: TrachelectomyParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| CisplatinCisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer. | Drug | Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy |
| CarboplatinCarboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer. | Drug | Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy |
| PaclitaxelPaclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer. | Drug | Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy |
| TrachelectomySurgery to remove the cervix but keep the uterus intact. | Procedure or surgery | Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy |
Primary outcome
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
Time frame: 2 years
9 secondary outcomes
Number of side effects
Time frame: 2 years
Rate of completion of neo-adjuvant chemotherapy
Time frame: 2 years
Response rate following neo-adjuvant chemotherapy
Time frame: 2 years
Rate of fertility sparing surgery
Time frame: 2 years
Surgical complication rate following fertility sparing surgery
Time frame: 2 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Stephanie Lheureux, M.D. principal investigator
Princess Margaret Cancer Centre
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cisplatin, Carboplatin and Paclitaxel in people with Cervical Cancer, run by University Health Network, Toronto at 4 sites in 2 countries.
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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Lheureux, M.D. (416-946-2818, stephanie.lheureux@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy (time frame: 2 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 12 Aug 2025.