| ID | Type | Description | Link |
|---|---|---|---|
| CoNteSSa - NeoCon | Other Identifier | Princess Margaret Cancer Centre |
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| Name | Class |
|---|---|
| Hotel Dieu Hospital | OTHER |
| The Netherlands Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of side effects | By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 2 years |
| Rate of completion of neo-adjuvant chemotherapy | 2 years |
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Inclusion Criteria:
Part 1 - Eligibility Criteria for Neoadjuvant Chemotherapy
Part 2 - Eligibility Criteria for Fertility Sparing Surgery (FSS)
Exclusion Criteria:
Part 1 - Exclusion Criteria for Neoadjuvant Chemotherapy
Part 2 - Exclusion Criteria for Fertility Sparing Surgery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Lheureux, M.D. | Contact | 416-946-2818 | stephanie.lheureux@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Lheureux, M.D. | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Centre | Terminated | Houston | Texas | 77030 | United States | |
| Sunnybrook Health Sciences Centre |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000069339 | Trachelectomy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Carboplatin | Drug | Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer. |
|
| Paclitaxel | Drug | Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer. |
|
| Trachelectomy | Procedure | Surgery to remove the cervix but keep the uterus intact. |
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| Response rate following neo-adjuvant chemotherapy | By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 2 years |
| Rate of fertility sparing surgery | 2 years |
| Surgical complication rate following fertility sparing surgery | By Clavien-Dindo classification of surgical morbidity | 2 years |
| Rate of recurrence-free survival | 2 years |
| Rate of recurrence-free survival | 3 years |
| Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery | 2 years |
| Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery | 3 years |
| Recruiting |
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
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| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| L'Hôtel-Dieu de Québec | Recruiting | Québec | Quebec | G1R 2J6 | Canada |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D007044 | Hysterectomy |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |