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Platinum-based Chemotherapy

Chemotherapy + Fertility-Sparing Surgery for Cervical Cancer (CoNteSSa Trial)

N/A

Recruiting

Led By Stephanie Lheureux, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be premenopausal and wish to preserve fertility.

Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

CoNteSSa Trial Summary

This trial will help researchers learn more about how well this approach works in preserving fertility in these patients and what the side effects are.

Who is the study for?

This trial is for premenopausal women with FIGO 2018 Stage IB2 cervical cancer who wish to preserve fertility and haven't had prior cancer treatments. They should have a good performance status, no uncontrolled infections, measurable disease per RECIST 1.1, and normal organ/marrow function. Participants must agree to use contraception.Check my eligibility

What is being tested?

The study tests if neoadjuvant chemotherapy (cisplatin or carboplatin plus paclitaxel) before fertility-sparing surgery can maintain fertility in patients with invasive cervical cancer. It aims to see if this approach reduces long-term infertility risks compared to surgery alone.See study design

What are the potential side effects?

Common side effects of the chemotherapy drugs cisplatin, carboplatin, and paclitaxel include nausea, fatigue, hair loss, nerve damage leading to numbness or tingling sensations in hands/feet (neuropathy), low blood cell counts increasing infection risk.

CoNteSSa Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am premenopausal and want to keep my ability to have children.

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My organ and bone marrow functions are normal.

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I have not received any treatment for my cancer lesion.

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I am able to care for myself and perform daily activities.

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My cervical cancer is confirmed and measures between >2 cm and ≤4 cm.

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I've finished 3 chemotherapy cycles with my tumor shrinking to less than 2 cm.

CoNteSSa Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Number of side effects

Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery

Rate of completion of neo-adjuvant chemotherapy

+4 more

CoNteSSa Trial Design

1Treatment groups

Experimental Treatment

Group I: Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant ChemotherapyExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

Paclitaxel

FDA approved

Carboplatin

FDA approved

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hotel Dieu HospitalOTHER

20 Previous Clinical Trials

19,908 Total Patients Enrolled

The Netherlands Cancer InstituteOTHER

291 Previous Clinical Trials

211,369 Total Patients Enrolled

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,903 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04016389 — N/A

Cervical Cancer Research Study Groups: Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy

Cervical Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04016389 — N/A

Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04016389 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any other studies conducted with Cisplatin as a major component?

"Cisplatin was initially trialled in 1997 at City of Hope Comprehensive Cancer Center, leading to 2277 completed studies. Currently 1527 active clinical trials are underway with a significant concentration located in Houston, Texas."

Answered by AI

To whom is this scientific investigation open?

"This medical trial has space for 90 individuals suffering from cervical cancer, aged 18 to 40. The key requirements include not having had any prior treatment for the lesion, an Eastern Cooperative Group (ECOG) performance status of no more than 2, a lack of active infection and RECIST 1.1 measurable disease, premenopausal reproductive health with fertility preservation desires as well as normal organ and marrow function within seven days before commencing therapy."

Answered by AI

How extensive is the cohort of individuals involved in this research endeavor?

"Affirmative. Information hosted on clinicaltrials.gov verifies that this medical trial, initially posted in February of 2020, is actively seeking patients for enrollment. A total of 90 participants are expected to join the study from 3 different sites."

Answered by AI

Does this research allow for the involvement of younger participants?

"To be eligible for this trial, patients must be within the range of 18 to 40 years old. In contrast, 118 studies are available to those under 18 and a further 1,802 trials target individuals over 65."

Answered by AI

What conditions are usually treated with the drug Cisplatin?

"Cisplatin is generally used to treat late-stage endometrial cancer, however it may be prescribed for other malignant conditions such as melanoma, neoplasm metastasis, lymphomas and non-Hodgkin's diseases."

Answered by AI

Is there ongoing recruitment for participation in this clinical trial?

"Affirmative. Per the information posted on clinicaltrials.gov, this medical experiment is actively recruiting participants with an original posting date of February 11th 2020 and a recent edit made on September 29th 2021. Ninety patients are being recruited from three trial sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04016389.

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