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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.

Must not have

Residual lesion > 2cm or disease progression while on chemotherapy

Patient unable to complete 3 cycles of neoadjuvant chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has grown or remained larger than 2cm despite chemotherapy.

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I couldn't complete 3 cycles of initial cancer treatment before surgery.

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I do not have brain metastases.

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I have undergone chemotherapy, radiotherapy, or surgery for my cancer.

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I do not have any serious illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of side effects

Response rate following neo-adjuvant chemotherapy

Surgical complication rate following fertility sparing surgery

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Carboplatin

FDA approved

Paclitaxel

FDA approved

0 / 11Eligibility criteria met