RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-02-11

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04016389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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.	* 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. * 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

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.

* 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.
* 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

Contacts and Locations

Study Contact

Stephanie Lheureux, M.D.

CONTACT

416-946-2818

stephanie.lheureux@uhn.ca

Principal Investigator

Stephanie Lheureux, M.D.

PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Study Locations (Sites)

MD Anderson Cancer Centre

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: University Health Network, Toronto

Stephanie Lheureux, M.D., PRINCIPAL_INVESTIGATOR, Princess Margaret Cancer Centre

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-11

Study Completion Date2025-06

Study Record Updates

Study Start Date2020-02-11

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Cervical Cancer