Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

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.

Trachelectomy

Stephanie Lheureux, M.D.

Lauren Cobb, MD

Allan Covens, MD

Marie Plante, M.D.

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.

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

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

By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

By Clavien-Dindo classification of surgical morbidity

Hotel Dieu Hospital

The Netherlands Cancer Institute

University Health Network, Toronto

Behaviors and Mental Disorders

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Carcinoma, Adenosquamous

Quality of Life

Radical trachelectomy outcomes for cervical cancer

5 Questionnaires at differing times before and after surgery.

Questionnaires

Michael M. Frumovitz, MD

The goal of this research study is to learn about quality of life, sexual functioning, and symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer.

This is an investigational study.

Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Before Surgery:

If you agree to take part in this study, before you have the abdominal radical trachelectomy surgery, the following information will be recorded during one of your regular clinic visits:

* Your race and date of birth.
* Your complete medical and surgical history, including the date of your diagnosis and your diagnosis before surgery.
* Your weight, height, and body mass index.

During and After Surgery:

During and after surgery, the following information will be gathered from your medical record or you will be asked:

* If there was any blood loss during surgery.
* How long the surgery lasted.
* If there were any complications during the surgery.
* If you needed any blood transfusions.
* What type of instrument was used for preventing or sealing blood loss.
* How long you stayed in the hospital.
* If you experienced any infections within 1 month after surgery.
* If you experienced any complications within 1 month or later than 1 month after surgery.
* The length of time it took to recover your bowel and urinary function.
* If you received any treatments for cancer after surgery, such as radiation therapy, chemotherapy, or hormonal therapy.

Once a year for up to 5 years, if you return for an annual routine follow up visit, the results of any pap smears you have had will be collected.

Once a year for up to 5 years, you will also be asked the following questions about your health and fertility, either by mail or during a regular clinic visit:

* What is the status of the disease?
* Did you want to get pregnant in the last year?
* Did you attempt to get pregnant?
* Did you become pregnant? If so, how you became pregnant and the outcome of the pregnancy? If not how long did you try to become pregnant and did you try any form of assisted reproduction?

Questionnaires:

You will complete 4-5 questionnaires at each of the following times:

* Within 2 weeks before your surgery.
* At 4-6 weeks after surgery
* At 6 months after surgery.
* At 1 year after surgery.
* Once a year for the next 4 years.

These questionnaires will ask about your physical health, mental and emotional health, pain, vitality, social functioning, general health, quality of life, and sexual functioning. It will take about 15 minutes to complete 5 questionnaires. If you do not receive your follow-up care at MD Anderson, the questionnaires will be mailed to you at the above time-points with a prepaid return envelope. Mailed questionnaires will be returned to the study chair in an envelope marked CONFIDENTIAL with NO RETURN ADDRESS on the return envelope. Your name will not appear on the questionnaires or return envelope. Instead, a code will be used (on the questionnaires only) that will connect the questionnaires with your medical record. Only the study chair or study coordinator will have access to the code document. The document is kept in a locked filing cabinet and/or password protected computer. All responses will be stored in a locked office.

Length of Study:

You will be on study for up to 5 years. If the disease returns, you will be taken off study.

Radical Trachelectomy for Women With Early Stage Cervical Cancer

Completed SF-12 questionnaires at baseline and at each follow-up visit (4-6 weeks, 6 months, 1 year, and annually for 4 more years)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery	NCT04016389	Cervical Cancer	Cisplatin Carboplatin Paclitaxel Trachelectomy	18 Years - 40 Years	University Health Network, Toronto
Radical Trachelectomy for Women With Early Stage Cervical Cancer	NCT00813007	Cervical Cancer	Questionnaires	18 Years - 40 Years	M.D. Anderson Cancer Center
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery	NCT04016389	Cervical Cancer	Cisplatin Carboplatin Paclitaxel Trachelectomy	18 Years - 40 Years	University Health Network, Toronto

Spots Global Cancer Trial Database for trachelectomy