Testing Cisplatin with Carboplatin for cervical cancer
Official title: FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
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
- 1 group
- Sites in Toronto and Québec
- Recruiting
Interventions (4)
- Medication
Cisplatin
Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
- Medication
Carboplatin
Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
- Medication
Paclitaxel
Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
- Medical procedure
Trachelectomy
Surgery to remove the cervix but keep the uterus intact.
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
- Recruiting
L'Hôtel-Dieu de Québec
Québec, Quebec
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → document.
- +Part 1 - Eligibility CriteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → for Neoadjuvant Chemotherapy
- +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
- −History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study.
- −Patients with known / evidence of brain metastases are excluded from participation in this clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
- −Patients who are receiving any other investigational agents.
- −Patients with other cancers requiring ongoing treatment.
- −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.
- −Any other condition that would, in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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.
- −Patients who are pregnant or breastfeeding
- −Part 1 - Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for Neoadjuvant Chemotherapy
- −Patients who have had chemotherapy or radiotherapy or surgery for their cancer.
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group, which receives one or more of: Cisplatin, Carboplatin, Paclitaxel and Trachelectomy.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 40 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 31 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy — measured over 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04016389 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CisplatinDrug
Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CarboplatinDrug
Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PaclitaxelDrug
Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TrachelectomyProcedure
Surgery to remove the cervix but keep the uterus intact.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 40 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 2 years.
The study as a whole is currently expected to finish around 2028-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 31 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Toronto, Ontario, Canada; Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.