Trachelectomy for Cervical Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
L'Hôtel-Dieu de Québec, Québec, Canada
Cervical Cancers+1 More
Trachelectomy - Procedure
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

This study is evaluating whether neo-adjuvant chemotherapy can maintain fertility in women with invasive cervical cancer.

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Eligible Conditions

  • Cervical Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cervical Cancers

Study Objectives

This trial is evaluating whether Trachelectomy will improve 1 primary outcome and 7 secondary outcomes in patients with Cervical Cancers. Measurement will happen over the course of 2 years.

2 years
Number of side effects
Rate of completion of neo-adjuvant chemotherapy
Rate of fertility sparing surgery
Rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy
Response rate following neo-adjuvant chemotherapy
Surgical complication rate following fertility sparing surgery
3 years
Overall survival for patients who undergo neo-adjuvant chemotherapy followed by fertility sparing surgery
Rate of recurrence-free survival

Trial Safety

Safety Progress

1 of 3

Other trials for Cervical Cancers

Trial Design

1 Treatment Group

Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant Chemotherapy
1 of 1
Experimental Treatment

This trial requires 90 total participants across 1 different treatment group

This trial involves a single treatment. Trachelectomy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Neo-Adjuvant Chemotherapy, Surgery, and Adjuvant ChemotherapyParticipants 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
Paclitaxel
FDA approved
Cisplatin
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Closest Location

L'Hôtel-Dieu de Québec - Québec, Canada

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient may not have had any prior therapy to treat their cancer lesion when they registered. show original
The patient has a performance status of ≤ 2 as assessed by the Eastern Cooperative Group (ECOG). show original
No evidence of an active infection that is not being controlled (patients on antibiotics are eligible). show original
The patient should be able to understand the consent form and be willing to sign it. show original
The patient must have a cancer that can be measured using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. show original
Study participants must use effective contraception before and during the study, as well as for a year after the treatment show original
To be eligible for neoadjuvant chemotherapy, a patient must have a histologic diagnosis of stage II or III breast cancer show original
Patients who have been diagnosed with invasive cervical cancer and meet certain size requirements are eligible to participate in this study show original
Women who are premenopausal and want to keep their fertility can be patients. show original
Within 7 days of proposed start of treatment, patients must have normal organ and marrow function or they may not be able to start treatment. show original

Patient Q&A Section

What are the signs of uterine cervical neoplasms?

"Cervical lesions have a number of signs, including dysplasia, cervical discharge and abnormalities on cervical cytology. Cervical cancer is rare in this population and other common symptoms will often be present, although the individual may lack awareness of the symptom pattern." - Anonymous Online Contributor

Unverified Answer

What are common treatments for uterine cervical neoplasms?

"The most common treatment for uterine cervical neoplasms is surgical excision. Surgical procedure usually is followed by a long course of post-operative radiotherapy. A number of nonsurgical treatments are also employed to treat cervical neoplasms, such as cryosurgery, chemotherapy, or radiotherapy." - Anonymous Online Contributor

Unverified Answer

Can uterine cervical neoplasms be cured?

"Patients with CIN who receive definitive surgical treatment for SCC and those with CIS can expect to have improved long-term survival. If the initial treatment of these patients consists of hysterectomy or excision followed by radiation and/or chemotherapy, then some patients can be cured. However, these patients are also aware that they will most likely never be normal and only have a 50% chance of cure." - Anonymous Online Contributor

Unverified Answer

How many people get uterine cervical neoplasms a year in the United States?

"Based on the above estimates, nearly 1 million women in the United States [get] uterine cervical cytologic abnormalities and most (about 90%) would be diagnosed with invasive carcinoma of the uterine cervix per year." - Anonymous Online Contributor

Unverified Answer

What causes uterine cervical neoplasms?

"What causes uterine cervical neoplasms? A close association with papillomaviridae exists. Moreover, the papillomavirus is found by different authors in both CIN and SCC of the uterine cervix. These two lesions seems to be a consequence of the same virus." - Anonymous Online Contributor

Unverified Answer

What is uterine cervical neoplasms?

"Cervical neoplasms appear as solid or cystic masses and usually cause abnormal bleeding. The most common histology is an adenocarcinoma and the most common symptom is abnormal uterine bleeding. The definitive diagnosis is by means of cytology or histopathology." - Anonymous Online Contributor

Unverified Answer

Has trachelectomy proven to be more effective than a placebo?

"The improvement of patient's cough after trachelectomy, and its reduction of the need for medical, psychological, and occupational therapy may be considered as a positive effect of the surgical procedure, thus the patient and the general practitioners can start the rehabilitation program earlier." - Anonymous Online Contributor

Unverified Answer

Is trachelectomy safe for people?

"The rate of mortality after trachelectomy for cancer was low, and the survival curves for the different cohorts were not significantly different. Results from a recent clinical trial justify proceeding with trachelectomy for cancer with high grade dysplasia because of low incidence and mortality." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving trachelectomy?

"Clinical trials involving trachelectomy have been published in peer-reviewed journals and have demonstrated survival benefits. However, because trachelectomy is a "low-volume" surgical procedure, there are limited numbers of patients, trials, and studies; thus, the results and data should be regarded with great caution." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of uterine cervical neoplasms?

"The main risk factor for developing cervical neoplasm is poor hygiene. Smoking (especially during pregnancy), use of oral contraceptives and hormonal replacement therapy, early age at first coitus, and chronic diseases such as diabetes were also risk factors. The main risk factor for cervical carcinoma was a positive family history of cervical neoplasms." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of trachelectomy?

"Trachelectomy is a safe and effective surgical procedure, with acceptable morbidity and low mortality. Trachelectomy is associated with common adverse effects: dyspnea, hoarseness, and dysphagia. Patients must be informed of the side effects of trachelectomy before the surgery, and must anticipate that the dysphagia will be persistent for some time after the operation. We emphasize that patients should not be anxious or distressed during rehabilitation because this has no effect on the final voice quality." - Anonymous Online Contributor

Unverified Answer

What is trachelectomy?

"The current data show that the peritracheal approach provides a significant improvement in ease of trachelectomy and less blood loss when compared with the anterior cervical approach. However, further prospective studies are necessary to confirm these initial results." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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