Fertility-Sparing Surgery for Endometrial Cancer

(FETCH Trial)

Overseen By Neeraj Mehra, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Vancouver Coastal Health Research Institute

Must be taking: High-dose progestin

Disqualifiers: Age 40+, Grade 2/3 cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a surgical method called hysteroscopic uterine resection to assist women with certain types of early-stage endometrial cancer or pre-cancer who wish to preserve fertility. It focuses on women who have tried anti-hormone treatments for at least six months without success. Women under 40, who want to maintain fertility and have a specific type of early cancer or pre-cancer, might be suitable candidates. The goal is to determine if this surgery can be a safe and effective option for them. As an unphased trial, this study provides a unique opportunity for women to explore a fertility-preserving surgical option that might not be available elsewhere.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have already tried anti-hormone therapy, like high-dose progestin, for at least 6 months before participating.

What prior data suggests that this surgical technique is safe for fertility preservation?

Research has shown that hysteroscopic uterine resection offers a safe and less invasive treatment for certain uterine conditions. Studies have found that this procedure typically involves fewer risks and a quicker recovery time compared to more invasive surgeries. Most patients tolerate it well. Reports indicate that serious complications are rare, though risks such as bleeding or infection can occur, as with any surgery. Overall, evidence suggests this is a well-tolerated option for preserving fertility while managing endometrial conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hysteroscopic uterine resection is unique because it offers a fertility-sparing option for women with endometrial cancer, unlike the traditional approach of a full hysterectomy, which removes the uterus and eliminates the possibility of future pregnancies. This technique involves the precise removal of cancerous tissue using a hysteroscope, a thin tube with a camera and surgical tools, which allows for a minimally invasive procedure. Researchers are excited about this treatment because it aims to effectively treat cancer while preserving fertility, offering hope to women who wish to maintain their ability to have children.

What evidence suggests that hysteroscopic uterine resection is effective for preserving fertility in endometrial cancer?

Research has shown that hysteroscopic uterine resection, which participants in this trial will undergo, can be effective for women with early-stage endometrial cancer who wish to preserve fertility. One study found that this procedure, when combined with a hormonal therapy device, yielded promising results in treating early-stage cancer. Other studies suggest that hysteroscopic procedures carry less risk and offer similar cancer outcomes compared to traditional methods. However, some findings indicate that hysteroscopic resection alone might not completely remove the cancer. Overall, hysteroscopy is considered a promising option for those seeking to balance treatment with fertility preservation. ^{2 3 4 6 7}

Who Is on the Research Team?

Mark Carey, MD

Principal Investigator

Vancouver Coastal Health

Are You a Good Fit for This Trial?

This trial is for women under 40 with early-stage endometrial cancer or atypical hyperplasia who haven't improved with hormone therapy and want to keep their fertility. They should have less than a third of the uterus affected, no severe health issues that could complicate surgery, and a reasonable chance to conceive as assessed by a fertility specialist.

Inclusion Criteria

I have been on progesterone therapy for at least 6 months.

Progestin therapy did not work for my uterine condition or I couldn't tolerate its side effects.

My biopsy shows early-stage endometrial cancer with limited spread.

Exclusion Criteria

I am unable to understand and give consent for my treatment.

I don't have any other cancers or conditions that could affect surgery outcomes.

My Grade I endometrial cancer affects more than one-third of the uterus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hysteroscopic endomyometrial resection to treat atypical hyperplasia or Grade I endometrial cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for local disease control and complications post-resection

3 months

Multiple visits (in-person)

Long-term Follow-up

Participants are monitored for distant disease control and conception rates

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Hysteroscopic uterine resection

Trial Overview The study tests hysteroscopic resection—a surgical procedure using an instrument inserted through the vagina to remove abnormal tissue from the uterus—in patients desiring fertility preservation after unsuccessful hormone treatment for certain uterine conditions.

How Is the Trial Designed?

Group I: Hysteroscopic uterine resection Experimental Treatment 1 Intervention

This is a prospective single-arm surgical intervention trial.

Hysteroscopic uterine resection is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hysteroscopic surgery for:

• Abnormal uterine bleeding
• Endometrial hyperplasia
• Endometrial cancer
• Fibroids
• Polyps
• Uterine adhesions

Approved in United States as Hysteroscopic surgery for:

• Abnormal uterine bleeding
• Endometrial hyperplasia
• Endometrial cancer
• Fibroids
• Polyps
• Uterine adhesions
• Sterilization

Approved in Canada as Hysteroscopic surgery for:

• Abnormal uterine bleeding
• Endometrial hyperplasia
• Endometrial cancer
• Fibroids
• Polyps
• Uterine adhesions

Who Is Running the Clinical Trial?

Vancouver Coastal Health Research Institute

Lead Sponsor

Trials

30

Recruited

5,600+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

Hysteroscopic endometrial resection followed by progestin therapy is an effective conservative treatment for early endometrial cancer and atypical hyperplasia in women of reproductive age, with 10 out of 11 patients showing no residual disease after 12 months.

The treatment does not appear to negatively impact fertility, as 54.5% of patients achieved pregnancies, including successful deliveries, indicating that this approach can be a viable option for women wishing to conceive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of hysteroscopic endometrectomy in the conservative treatment of early endometrial cancer and atypical hyperplasia in fertile women. Atallah, D., El Kassis, N., Safi, J., et al.[2021]

In a study of 111 premenopausal women with menorrhagia, 77.4% experienced a normal menstrual pattern or amenorrhea after undergoing hysteroscopic endometrial resection, indicating its long-term efficacy as a treatment option.

The success rate was significantly higher in women over 49 years old (94%) compared to younger women (70%), suggesting that age may influence the effectiveness of this conservative surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcervical endometrial resection in women with menorrhagia: long-term follow-up. Litta, P., Merlin, F., Pozzan, C., et al.[2006]

Conservative management of stage IA endometrial cancer using hysteroscopic surgery combined with medical therapy can effectively preserve fertility, as demonstrated in two cases, including one successful pregnancy through assisted reproductive technology.

Incorporating hysteroscopic resection into treatment may enhance response and reduce recurrence rates, while also facilitating quicker remission and faster return to fertility, highlighting the importance of a skilled interdisciplinary team and thorough patient counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic resection in the management of early-stage endometrial cancer: report of 2 cases and review of the literature. Arendas, K., Aldossary, M., Cipolla, A., et al.[2018]

Endometrial cancer, the most common gynecologic cancer, can affect younger women, with 2-14% of cases occurring in those under 45 years old.

Conservative treatment options, such as hysteroscopic resection, are being explored to preserve fertility in selected patients with endometrial cancer, highlighting the importance of tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic surgery for conservative management in endometrial cancer: a review of the literature. Alonso, S., Castellanos, T., Lapuente, F., et al.[2020]

In a study involving six young women with early-stage endometrial cancer, hysteroscopic tumor resection followed by progestin therapy resulted in complete tumor remission for all patients, demonstrating its efficacy as a conservative treatment option.

This approach not only effectively treated the cancer but also allowed one patient to achieve a successful pregnancy and delivery, highlighting its potential for fertility preservation in young women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fertility-preserving treatment of stage IA, well-differentiated endometrial carcinoma in young women with hysteroscopic resection and high-dose progesterone therapy. Yang, HC., Liu, JC., Liu, FS.[2019]

Operative hysteroscopy is a minimally invasive and cost-effective procedure for treating benign uterine disorders, offering a safe alternative to major surgeries with low complication rates.

Awareness and management of potential complications, such as bleeding and uterine perforation, are essential for optimizing patient care and improving the safety of hysteroscopic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in operative hysteroscopy - is prevention possible? Aas-Eng, MK., Langebrekke, A., Hudelist, G.[2017]

In a retrospective study of 196 patients who underwent hysteroscopic endometrial resection, an 82% satisfaction rate was reported, although many experienced abnormal bleeding again, sometimes after 2 years of remission.

Key risk factors for treatment failure included enlarged uterine size and the presence of adenomyosis, highlighting the need for long-term follow-up to monitor for late recurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Failure factors in endometrial resection. 196 cases]. Raiga, J., Bowen, J., Glowaczower, E., et al.[2010]

Adverse events from hysteroscopic procedures are generally rare but are becoming more common as the complexity of these surgeries increases, with complications ranging from anesthesia issues to specific injuries like perforation.

Special attention is needed for premenopausal women, as they may experience unique responses to fluid absorption and complications from monopolar resectoscopes, highlighting the importance of understanding these risks to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of hysteroscopic and uterine resectoscopic surgery. Munro, MG.[2019]

In a pilot study involving 73 women, hysteroscopic resection of endometrial hyperplasia without atypia was effective, resulting in complete remission of uterine bleeding in 44 cycling women and no cases of persistent hyperplasia during follow-up.

The procedure demonstrated a good safety profile, with only four women requiring hysterectomy, indicating that hysteroscopic resection can effectively treat endometrial hyperplasia while minimizing the need for more invasive surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic resection of endometrial hyperplasia. Cianferoni, L., Giannini, A., Franchini, M.[2019]

Hysteroscopic resection of endometrial polyps is highly effective, with a success rate of 96.4% observed in a study of 367 patients over a median follow-up of 40 months.

Patients who underwent associated endometrial resection alongside polyp removal had an even higher success rate of 98.3%, suggesting that this approach may be beneficial for older patients or those not concerned about preserving fertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term results of hysteroscopic resection of endometrial polyps in 367 patients. Role of associated endometrial resection]. Polena, V., Mergui, JL., Zérat, L., et al.[2022]

Adverse events from hysteroscopic procedures are rare but are becoming more common with increased complexity, including risks like perforation and injuries to surrounding structures.

Understanding the unique responses of premenopausal women to fluid absorption during hysteroscopy and the potential for thermal injuries from monopolar devices can help surgeons minimize risks and improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Hysteroscopic and Uterine Resectoscopic Surgery. Munro, MG., Christianson, LA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6543116/

Conservative hysteroscopic treatment of stage I well ... The alternative treatment with endo-myometrial hysteroscopic resection and LNG-IUD in women with stage IA, grade 1 endometrioid EC showed initial encouraging ...

2. ar.iiarjournals.org ar.iiarjournals.org/content/36/8/4341

Outcome and Follow-up of Patients with Endometrial ... Two deaths were observed and were attributed to endometrial cancer. Conclusion: Operative hysteroscopy does not appear to influence stage of EC nor cause ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465017304405

Hysterscopic Resection of Premalignant and Malignant ... Our results indicate that hysteroscopic evaluation of the uterine cavity and polyp resection are not enough for the eradication of premalignant and malignant ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/ijgo.70320

Conservative hysteroscopic treatment of endometrial ... In conclusion, mHTR systems for endo-myometrial resection demonstrate comparable oncologic outcomes to resectoscopic hysteroscopy for patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8799018/

Hysteroscopy in the management of endometrial hyperplasia ... Studies comparing D&C with hysteroscopically-guided endometrial biopsy have demonstrated that hysteroscopy is a less risky procedure with higher diagnostic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4335962/

Hysteroscopic surgery for conservative management in ... In this article, we review the literature to evaluate the results of conservative treatment of endometrial cancer with hysteroscopic resection.

7. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/03/the-use-of-hysteroscopy-for-the-diagnosis-and-treatment-of-intrauterine-pathology

The Use of Hysteroscopy for the Diagnosis and Treatment ... Potential advantages of hysteroscopic tissue removal systems are shorter operative time and higher likelihood of complete lesion removal (endometrial polyp, ...