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

NCT04016389 | Recruiting DMC

• 2 other identifiers: CoNteSSaCoNteSSa - NeoCon
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy

  2 years

Secondary Outcomes (9)

• Number of side effects

  2 years

• Rate of completion of neo-adjuvant chemotherapy

  2 years

• Response rate following neo-adjuvant chemotherapy

  2 years

• Rate of fertility sparing surgery

  2 years

• Surgical complication rate following fertility sparing surgery

  2 years

Study Arms (1)

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.

Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Trachelectomy

Interventions

Cisplatin DRUG

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

Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy

Carboplatin DRUG

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

Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy

Paclitaxel DRUG

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

Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy

Trachelectomy PROCEDURE

Surgery to remove the cervix but keep the uterus intact.

Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Hotel Dieu Hospital: collaborator
• The Netherlands Cancer Institute: collaborator

Study Sites (4)

MD Anderson Cancer Centre

Houston, Texas, 77030, United States

TERMINATED

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

L'Hôtel-Dieu de Québec

Québec, Quebec, G1R 2J6, Canada

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Carboplatin; Paclitaxel; Trachelectomy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Stephanie Lheureux, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Lheureux, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: February 11, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (3)