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

Part of paid clinical trials in Houston, Texas.

Sponsor
University Health Network, Toronto
Study ID
NCT04016389
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 11, 2020
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CentreHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
MD Anderson Cancer Centre· Houston, TX

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