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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Trachelectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Lheureux, M.D.; Phone Number: 416-946-2818; Email: stephanie.lheureux@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Allan Covens, MD; Phone Number: 416-480-4026; Email: al.covens@sunnybrook.ca
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
      • Contact: Stephanie Lheureux, M.D.; Phone Number: 416-946-2818; Email: stephanie.lheureux@uhn.ca
  • Quebec
    • Québec, Quebec, Canada, G1R 2J6
      • Recruiting
      • L'Hôtel-Dieu de Québec
      • Contact: Marie Plante, M.D.; Email: Marie.Plante@crchudequebec.ulaval.ca
• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Centre
      • Contact: Lauren Cobb, MD; Phone Number: 713-745-8511; Email: lpcobb@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: Cisplatin; Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.; Drug: Carboplatin; Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.; Drug: Paclitaxel; Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.; Procedure: Trachelectomy; Surgery to remove the cervix but keep the uterus intact.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: The Netherlands Cancer Institute; Hotel Dieu Hospital
• Investigators: Principal Investigator: Stephanie Lheureux, M.D., Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: 19-5443; CoNteSSa - NeoCon (Other Identifier: Princess Margaret Cancer Centre)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No