Recruiting

Neoadjuvant Chemotherapy

Sponsor:

University Health Network, Toronto

Code:

NCT04016389

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Cisplatin

Carboplatin

Paclitaxel

Trachelectomy

Study Details

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.

Conditions

Cervical Cancer

Study ID

NCT04016389

Start date

Feb 11, 2020

Status verified date

Aug, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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 ≤ 2.
  • 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) 1.1.
  • 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.

Part 2 - Eligibility Criteria for Fertility Sparing Surgery (FSS)

  • Completed 3 cycles of neo-adjuvant chemotherapy and achieved a complete response (CR) or partial response (PR) with reduction of the lesion to <2 cm on physical examination and MRI.

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

  • Patient unable to complete 3 cycles of neoadjuvant chemotherapy
  • Suboptimal response to neoadjuvant chemotherapy according to investigator
  • Residual lesion > 2cm or disease progression while on chemotherapy

Study Design

Enrollment

31 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cisplatin

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

Carboplatin

Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.

Paclitaxel

Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.

Trachelectomy

Surgery to remove the cervix but keep the uterus intact.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stephanie Lheureux, M.D.

416-946-2818stephanie.lheureux@uhn.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Allan Covens, MD

416-480-4026al.covens@sunnybrook.ca

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Stephanie Lheureux, M.D.

416-946-2818stephanie.lheureux@uhn.ca

L'Hôtel-Dieu de Québec

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Marie Plante, M.D.

Marie.Plante@crchudequebec.ulaval.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-08-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.