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.
Title
- Brief Title: Study of Neo-Adjuvant Chemotherapy and Surgery to Preserve Fertility in Patients With Cervical Cancer
- Official Title: FIGO 2018 Stage IB2 (≥2 to <4 cm) Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Clinical Trial IDs
- ORG STUDY ID:
19-5443
- SECONDARY ID:
CoNteSSa - NeoCon
- NCT ID:
NCT04016389
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Cisplatin | | Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy |
Carboplatin | | Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy |
Paclitaxel | | Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | - Cisplatin
- Carboplatin
- Paclitaxel
|
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 ≥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
Maximum Eligible Age: | 40 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of side effects |
Time Frame: | 2 years |
Safety Issue: | |
Description: | By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Measure: | Rate of completion of neo-adjuvant chemotherapy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Response rate following neo-adjuvant chemotherapy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
Measure: | Rate of fertility sparing surgery |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Surgical complication rate following fertility sparing surgery |
Time Frame: | 2 years |
Safety Issue: | |
Description: | By Clavien-Dindo classification of surgical morbidity |
Measure: | Rate of recurrence-free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Rate of recurrence-free survival |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University Health Network, Toronto |
Last Updated
July 8, 2021