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
Overview
- Phase
- Not Applicable
- Intervention
- Cisplatin
- Conditions
- Cervical Cancer
- Sponsor
- University Health Network, Toronto
- Enrollment
- 31
- Locations
- 4
- Primary Endpoint
- Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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.
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.
Investigators
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 \>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 ≤
- •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.
- •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.
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
Arms & Interventions
Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy
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.
Intervention: Cisplatin
Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy
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.
Intervention: Carboplatin
Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy
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.
Intervention: Paclitaxel
Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy
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.
Intervention: Trachelectomy
Outcomes
Primary Outcomes
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
Time Frame: 2 years
Secondary Outcomes
- Rate of recurrence-free survival(3 years)
- Rate of completion of neo-adjuvant chemotherapy(2 years)
- Response rate following neo-adjuvant chemotherapy(2 years)
- Rate of fertility sparing surgery(2 years)
- Surgical complication rate following fertility sparing surgery(2 years)
- Number of side effects(2 years)
- Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery(3 years)