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

Trial Summary

What is the purpose of this trial?

This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility.

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 data supports the effectiveness of the treatment Hysteroscopic uterine resection for fertility-sparing surgery in endometrial cancer?

Research shows that hysteroscopic endometrial resection can be effective in conservatively treating early endometrial cancer in women who want to preserve their fertility. It has been used successfully in some cases to manage early-stage endometrial cancer, allowing women to achieve pregnancy with assisted reproductive technology. ^{1 2 3 4 5}

Is hysteroscopic surgery generally safe for humans?

Hysteroscopic surgery is generally considered safe with rare complications, but as procedures become more complex, complications like bleeding, uterine perforation, and fluid overload can occur. Awareness and prevention of these issues help ensure patient safety. ^{2 6 7 8 9}

How is hysteroscopic uterine resection different from other treatments for endometrial cancer?

Hysteroscopic uterine resection is unique because it allows for the conservative management of early-stage endometrial cancer while preserving fertility, unlike the standard treatment of hysterectomy, which results in infertility. This approach combines surgery with hormone therapy and can lead to a faster return to fertility and shorter remission times. ^{1 2 4 10 11}

Research Team

Mark Carey, MD

Principal Investigator

Vancouver Coastal Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The use of hysteroscopic endometrectomy in the conservative treatment of early endometrial cancer and atypical hyperplasia in fertile women. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Transcervical endometrial resection in women with menorrhagia: long-term follow-up. [2006]

3. France pubmed.ncbi.nlm.nih.gov

[Failure factors in endometrial resection. 196 cases]. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Hysteroscopic resection in the management of early-stage endometrial cancer: report of 2 cases and review of the literature. [2018]

5. France pubmed.ncbi.nlm.nih.gov

[Long-term results of hysteroscopic resection of endometrial polyps in 367 patients. Role of associated endometrial resection]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Complications of hysteroscopic and uterine resectoscopic surgery. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Complications of Hysteroscopic and Uterine Resectoscopic Surgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Hysteroscopic resection of endometrial hyperplasia. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Complications in operative hysteroscopy - is prevention possible? [2017]

10. England pubmed.ncbi.nlm.nih.gov

Hysteroscopic surgery for conservative management in endometrial cancer: a review of the literature. [2020]

11. China (Republic : 1949- ) 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. [2019]