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New treatment option for Cervical Cancer
Official title FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
ClinicalTrials.gov ID: NCT04016389
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Toronto, Ontario, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Toronto, Ontario, Canada; Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.