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Study of Neo-Adjuvant Chemotherapy and Surgery to Preserve Fertility in Patients With Cervical Cancer (NeoCon-F)

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ClinicalTrials.gov Identifier: NCT04016389
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : March 3, 2021
Sponsor:
Collaborators:
Hotel Dieu Hospital
The Netherlands Cancer Institute
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Procedure: Trachelectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FIGO 2018 Stage IB2 (≥2 to <4 cm) Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.




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

Secondary Outcome Measures :
  1. Number of side effects [ Time Frame: 2 years ]
    By Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  2. Rate of completion of neo-adjuvant chemotherapy [ Time Frame: 2 years ]
  3. Response rate following neo-adjuvant chemotherapy [ Time Frame: 2 years ]
    By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  4. Rate of fertility sparing surgery [ Time Frame: 2 years ]
  5. Surgical complication rate following fertility sparing surgery [ Time Frame: 2 years ]
    By Clavien-Dindo classification of surgical morbidity

  6. Rate of recurrence-free survival [ Time Frame: 2 years ]
  7. Rate of recurrence-free survival [ Time Frame: 3 years ]
  8. Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery [ Time Frame: 2 years ]
  9. Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ≥2cm to <4cm 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016389


Contacts
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Contact: Stephanie Lheureux, M.D. 416-946-2818 stephanie.lheureux@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Stephanie Lheureux, M.D.    416-946-2818    stephanie.lheureux@uhn.ca   
Canada, Quebec
L'Hôtel-Dieu de Québec Recruiting
Québec, Quebec, Canada, G1R 2J6
Contact: Marie Plante, M.D.       Marie.Plante@crchudequebec.ulaval.ca   
Sponsors and Collaborators
University Health Network, Toronto
Hotel Dieu Hospital
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Stephanie Lheureux, M.D. Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04016389    
Other Study ID Numbers: 19-5443
CoNteSSa - NeoCon ( Other Identifier: Princess Margaret Cancer Centre )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action