Study of Neo-Adjuvant Chemotherapy and Surgery to Preserve Fertility in Patients With Cervical Cancer (NeoCon-F)
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|ClinicalTrials.gov Identifier: NCT04016389|
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : March 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Procedure: Trachelectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||June 2025|
Experimental: 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.
Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
Surgery to remove the cervix but keep the uterus intact.
- Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy [ Time Frame: 2 years ]
- Number of side effects [ Time Frame: 2 years ]By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Rate of completion of neo-adjuvant chemotherapy [ Time Frame: 2 years ]
- Response rate following neo-adjuvant chemotherapy [ Time Frame: 2 years ]By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Rate of fertility sparing surgery [ Time Frame: 2 years ]
- Surgical complication rate following fertility sparing surgery [ Time Frame: 2 years ]By Clavien-Dindo classification of surgical morbidity
- Rate of recurrence-free survival [ Time Frame: 2 years ]
- Rate of recurrence-free survival [ Time Frame: 3 years ]
- Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery [ Time Frame: 2 years ]
- Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016389
|Contact: Stephanie Lheureux, M.D.||firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Stephanie Lheureux, M.D. 416-946-2818 email@example.com|
|L'Hôtel-Dieu de Québec||Recruiting|
|Québec, Quebec, Canada, G1R 2J6|
|Contact: Marie Plante, M.D. Marie.Plante@crchudequebec.ulaval.ca|
|Principal Investigator:||Stephanie Lheureux, M.D.||Princess Margaret Cancer Centre|