Chemotherapy + Fertility-Sparing Surgery for Cervical Cancer
(CoNteSSa Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Must not be taking: Investigational agents
Disqualifiers: Other cancers, Brain metastases, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on investigational agents or treatments for other cancers, you may not be eligible to participate.
What data supports the effectiveness of the chemotherapy drugs used in the trial for cervical cancer?
Research shows that the combination of paclitaxel and carboplatin or cisplatin is effective in treating advanced or recurrent cervical cancer, with studies indicating it can help manage the disease, although it may have significant side effects.
12345Is the combination of chemotherapy drugs like paclitaxel and carboplatin or cisplatin safe for treating cervical cancer?
Research shows that the combination of paclitaxel with either carboplatin or cisplatin is generally safe for treating cervical cancer, though it can cause side effects like gastrointestinal issues and bone marrow suppression. Carboplatin is noted to have milder kidney-related side effects compared to cisplatin, making it a potentially safer option.
14567What makes the chemotherapy and fertility-sparing surgery treatment for cervical cancer unique?
This treatment combines chemotherapy with fertility-sparing surgery, which is different from standard treatments that often involve more aggressive surgery or radiation that can affect fertility. The use of carboplatin, cisplatin, and paclitaxel in this context aims to treat the cancer while preserving the patient's ability to have children.
23578Eligibility Criteria
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.Inclusion Criteria
I am premenopausal and want to keep my ability to have children.
Ability to understand and willing to sign a written informed consent document.
My organ and bone marrow functions are normal.
+9 more
Exclusion Criteria
My cancer has grown or remained larger than 2cm despite chemotherapy.
I couldn't complete 3 cycles of initial cancer treatment before surgery.
You have had allergic reactions to medications that are similar to paclitaxel, carboplatin, or cisplatin, or other drugs being used in the study.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neo-Adjuvant Chemotherapy
Participants receive platinum-based chemotherapy (cisplatin or carboplatin) with paclitaxel for three 21-day cycles
9 weeks
3 visits (in-person, one per cycle)
Surgery
Participants undergo trachelectomy if responding to treatment; otherwise, adjuvant treatment or hysterectomy may be performed
1-2 weeks
1 visit (in-person)
Adjuvant Treatment
Participants may receive additional chemotherapy and radiotherapy or undergo a hysterectomy based on post-surgery assessment
Varies
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Participant Groups
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.
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.
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
L'Hôtel-Dieu de QuébecQuébec, Canada
Sunnybrook Health Sciences CentreToronto, Canada
MD Anderson Cancer CentreHouston, TX
Princess Margaret Cancer CentreToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
Hotel Dieu HospitalCollaborator
The Netherlands Cancer InstituteCollaborator
References
Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel in patients with locally advanced uterine cervical cancer: The JACCRO GY-01 trial. [2016]A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer.
A phase II study of postoperative concurrent carboplatin and paclitaxel combined with intensity-modulated pelvic radiotherapy followed by consolidation chemotherapy in surgically treated cervical cancer patients with positive pelvic lymph nodes. [2017]A phase II study was conducted to evaluate the efficacy and toxicity of carboplatin plus paclitaxel (TC)-based postoperative concurrent chemoradiotherapy (CCRT) followed by TC-based consolidation chemotherapy in surgically-treated early-stage cervical cancer patients.
Carboplatin and paclitaxel for advanced and recurrent cervical carcinoma: the British Columbia Cancer Agency experience. [2022]One of the most active chemotherapy combinations in advanced or recurrent cervical cancer is cisplatin-paclitaxel. However, this palliative regimen is associated with significant toxicity. Carboplatin-paclitaxel is thus an attractive option.
Paclitaxel and carboplatin for recurrent or persistent cancer of the cervix. [2019]The objective of this study was to evaluate the effectiveness and degree of toxicity of paclitaxel and carboplatin (PC) combination chemotherapy in patients with recurrent or persistent cervical carcinoma.
[Neoadjuvant chemotherapy with paclitaxel and cisplantin or carboplatin for patients with locally advanced uterine cervical cancer]. [2015]To investigate the efficacy and toxicity of neoadjuvant chemotherapy with paclitaxel and carboplatin or cisplatin for patients with locally advanced cervical cancer.
A retrospective analysis of cisplatin/carboplatin plus paclitaxel in advanced or recurrent cervical cancer. [2019]To compare the efficacy and safety of paclitaxel plus carboplatin (TC) and paclitaxel plus cisplatin (TP) in the treatment of advanced or recurrent cervical cancer, this retrospective study included 116 advanced or recurrent cervical cancer cases treated at Beijing Obstetrics and Gynecology Hospital between June 2002 and June 2014. Of these cases, 52 were treated with TC (TC group) and 64 were treated with TP (TP group). We found that the overall survival and response and disease-control rates were not significantly different between the two groups. The TC group had a markedly lower incidence of Grade III-IV gastrointestinal toxicity reactions and a shorter hospitalisation stay than the TP group. The incidences of Grade III-IV bone marrow suppression and renal toxicity were not significantly different between the TP and TC groups. These findings suggest that TC may be a safe and effective alternative to TP for the treatment of advanced or recurrent cervical cancer. Impact Statement What is already known on this subject: Paclitaxel plus cisplatin (TP) is regarded as the standard regimen for cervical cancer, nevertheless, cisplatin is always associated with nephrotoxicity and requires hydration therapy. Carboplatin is a platinum analogue with milder nephrotoxicity than cisplatin. It is reported that carboplatin may be a viable and less toxic alternative to cisplatin in the management of advanced or recurrent cervical cancer, but another study shows that the therapeutic efficacy of paclitaxel plus carboplatin (TC) is non-inferior to that of TP. What the results of this study add: This study compared the efficacy and safety of TC and TP, and found that the TC and TP groups had similar overall response and disease-control rates and survival, but the TC group was better tolerated with a markedly lower incidence of Grades III-IV gastrointestinal toxicity reactions and had a shorter hospitalisation stay than the TP group. What the implications are of these findings for clinical practice and/or further research: TC may be a safe and effective alternative to TP for the treatment of advanced or recurrent cervical cancer in clinical practice.
Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. [2022]Purpose We compared the efficacy and toxicity of neoadjuvant chemotherapy followed by radical surgery versus standard cisplatin-based chemoradiation in patients with locally advanced squamous cervical cancer. Patients and Methods This was a single-center, phase III, randomized controlled trial ( ClinicalTrials.gov identifier: NCT00193739). Eligible patients were between 18 and 65 years old and had stage IB2, IIA, or IIB squamous cervical cancer. They were randomly assigned, after stratification by stage, to receive either three cycles of neoadjuvant chemotherapy using paclitaxel and carboplatin once every 3 weeks followed by radical hysterectomy or standard radiotherapy with concomitant cisplatin once every week for 5 weeks. Patients in the neoadjuvant group received postoperative adjuvant radiation or concomitant chemotherapy and radiotherapy, if indicated. The primary end point was disease-free survival (DFS), defined as survival without relapse or death related to cancer, and secondary end points included overall survival and toxicity. Results Between September 2003 and February 2015, 635 patients were randomly assigned, of whom 633 (316 patients in the neoadjuvant chemotherapy plus surgery group and 317 patients in the concomitant chemoradiation group) were included in the final analysis, with a median follow-up time of 58.5 months. The 5-year DFS in the neoadjuvant chemotherapy plus surgery group was 69.3% compared with 76.7% in the concomitant chemoradiation group (hazard ratio, 1.38; 95% CI, 1.02 to 1.87; P = .038), whereas the corresponding 5-year OS rates were 75.4% and 74.7%, respectively (hazard ratio, 1.025; 95% CI, 0.752 to 1.398; P = .87). The delayed toxicities at 24 months or later after treatment completion in the neoadjuvant chemotherapy plus surgery group versus the concomitant chemoradiation group were rectal (2.2% v 3.5%, respectively), bladder (1.6% v 3.5%, respectively), and vaginal (12.0% v 25.6%, respectively). Conclusion Cisplatin-based concomitant chemoradiation resulted in superior DFS compared with neoadjuvant chemotherapy followed by radical surgery in locally advanced cervical cancer.
Neoadjuvant chemotherapy with cisplatin, ifosfamide and paclitaxel for locally advanced squamous-cell cervical cancer. [2020]Neoadjuvant chemotherapy is increasingly being used for the treatment of bulky and locally-advanced cervical cancer. Cisplatin and ifosfamide are known to be effective in cervical cancer, while paclitaxel is one of the promising new drugs for the treatment of this neoplasm.