Endometrial Cancer Trial, Recruiting NCT04016389 Sponsor: University Health Network, Toronto Condition: Endometrial Cancer
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Endometrial Cancer Trial, Recruiting

NCT04016389
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Part 1 – Chemotherapy phase:

  • People who have been diagnosed with a specific type of invasive cervical cancer (adenocarcinoma, adenosquamous, or squamous cell type) where the tumour measures more than 2 cm but no larger than 4 cm, confirmed by MRI scan.
  • People who are premenopausal and wish to preserve their fertility.
  • People who have not received any previous treatment for their cervical cancer at the time of joining the trial.
  • People who are generally well enough to carry out daily activities, based on a standard health performance scale (ECOG score of 2 or below).
  • People whose blood tests show that their organs (such as kidneys, liver, and bone marrow) are working normally within 7 days before treatment is due to start.
  • People who have no active, uncontrolled infection at the time of joining (those already taking antibiotics may still be eligible).
  • People whose cancer can be measured using standard imaging guidelines (RECIST 1.1).
  • People who are willing and able to understand and sign a consent form.
  • People who agree to use effective contraception before, during, and for at least one year after any fertility-sparing surgery, and who have a negative pregnancy blood test within 72 hours before registering for the trial.

Part 2 – Fertility-sparing surgery phase:

  • People who have completed all 3 cycles of chemotherapy as part of this trial and whose tumour has either disappeared completely or shrunk to less than 2 cm on both physical examination and MRI scan.

Who may not be able to join:

Part 1 – Chemotherapy phase:

  • People who have already had chemotherapy, radiotherapy, or surgery to treat their cervical cancer.
  • People who are currently taking part in another clinical trial involving an experimental treatment.
  • People who have another type of cancer that currently requires active treatment.
  • People who have cancer that has spread to the brain.
  • People who have had a significant allergic reaction to drugs similar in makeup to paclitaxel, carboplatin, or cisplatin — the chemotherapy drugs used in this trial.
  • People with serious ongoing or uncontrolled health conditions, such as active infection, heart failure, unstable chest pain, irregular heartbeat, or significant mental health or personal circumstances that could affect their ability to participate safely.
  • People who are currently pregnant or breastfeeding.
  • People with any other condition that the trial doctor considers would make participation unsafe or difficult, such as a bowel blockage, difficulty swallowing, ongoing inflammation or infection, or significant social or psychological challenges (confirm with trial site).

Part 2 – Fertility-sparing surgery phase:

  • People who were unable to complete all 3 cycles of chemotherapy.
  • People whose cancer did not respond well enough to chemotherapy, as determined by the trial doctor.
  • People whose tumour remains larger than 2 cm after chemotherapy, or whose cancer grew or spread during chemotherapy.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Stephanie Lheureux, M.D., Princess Margaret Cancer Centre

Phone: 416-946-2818

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
11 February 2020
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov