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

  • STATUS
    Recruiting
  • End date
    Jun 9, 2025
  • participants needed
    90
  • sponsor
    University Health Network, Toronto
Updated on 9 October 2021
paclitaxel
carboplatin
chemotherapy drugs
adenocarcinoma
antineoplastic
immunomodulator
invasive cervical cancer
chemotherapeutic agent

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.

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.

Details
Condition cervix cancer, Cervical Cancer, cancer of the cervix, cervical cancer, uterine, carcinoma of the cervix uteri, cervical carcinoma, Uterine Serous Carcinoma, carcinoma of cervix, Disorders of cervix NOS, Uterine Cancer, carcinoma of the cervix
Treatment cisplatin, carboplatin, Paclitaxel, Trachelectomy, Trachelectomy
Clinical Study IdentifierNCT04016389
SponsorUniversity Health Network, Toronto
Last Modified on9 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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