Less Invasive Surgery for Early Stage Cervical Cancer

Recruiting at 21 trial locations

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: High-risk histologies, Grade 3 adenocarcinoma, Stage IA1, others

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 7 days

137 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Conservative Surgery for early-stage cervical cancer?

Research suggests that less radical or conservative surgeries for early-stage cervical cancer can be effective without compromising cancer outcomes. Studies have shown that these surgeries can preserve fertility and have comparable oncological results to more traditional, radical approaches. ^{1 2 3 4 5}

Is less invasive surgery for early-stage cervical cancer safe?

Research shows that minimally invasive surgery for early-stage cervical cancer may have more complications and a higher risk of cancer returning compared to traditional open surgery. However, specific safety data for conservative surgery in early-stage cervical cancer is limited. ^{6 7 8 9 10}

How is conservative surgery different from other treatments for early-stage cervical cancer?

Conservative surgery for early-stage cervical cancer is less invasive than traditional radical hysterectomy, aiming to reduce surgical complications while preserving fertility. It involves procedures like conization (removal of a cone-shaped section of the cervix) and trachelectomy (removal of the cervix while keeping the uterus), often combined with lymph node assessment, and is considered safe for selected patients. ^{2 6 11 12 13}

What is the purpose of this trial?

This clinical trial studies conservative surgery in treating patients with low-risk stage IA2 or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery.

Research Team

Kathleen M Schmeler

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women with early-stage cervical cancer (stage IA2 or IB1) that's less than 2 cm in size, without high-risk features like certain aggressive cell types or deep invasion into the cervix. Participants should not have had previous major treatments for their condition and must test negative for cancer spread.

Inclusion Criteria

My recent scans show no signs of cancer spread.

No lymphovascular space invasion (LVSI) present on biopsy or previous cone

Patients must sign an approved informed consent document

Exclusion Criteria

My biopsy shows early-stage cervical cancer or pre-cancer.

Patients unwilling or unable to provide informed consent for the study

My cancer is at an early or advanced stage, but not the earliest.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.

Up to 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then yearly for 3 years

Treatment Details

Interventions

• Conservative Surgery

Trial Overview The study tests conservative surgery options including sentinel lymph node biopsy and salpingo-oophorectomy to treat low-risk cervical cancer. It aims to see if these surgeries can effectively manage the disease while offering a better quality of life and quicker recovery.

Participant Groups

Group I: Treatment (conservative surgery) Experimental Treatment 5 Interventions

Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Minimally invasive hysterectomy for stage IA cervical carcinoma: a survival analysis of the National Cancer Database. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Is It Possible to Perform Less Radical Surgery for Invasive Uterine Cervical Cancer? [2018]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

[Fertility sparing surgery in early cervical cancer today and tomorrow]. [2016]

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

Is less more in the surgical treatment of early-stage cervical cancer? [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effect of modified radical laparoscopic hysterectomy versus open radical hysterectomy on short-term clinical outcomes in early-stage cervical cancer: a single-center, prospective, randomized controlled trial. [2023]

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

Ten-year outcomes following laparoscopic and open abdominal radical hysterectomy for "low-risk" early-stage cervical cancer: A propensity-score based analysis. [2023]

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

Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. [2017]

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

Thirty-day Postoperative Adverse Events in Minimally Invasive versus Open Abdominal Radical Hysterectomy for Early-stage Cervical Cancer. [2023]

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

Recurrence during pregnancy of a conservatively treated early-stage cervical squamous cell carcinoma. [2011]

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

The efficacy of pre-operative conization in patients undergoing surgical treatment for early-stage cervical cancer: A meta-analysis. [2023]

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

Conservative approaches in early stages of cervical cancer. [2007]

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

Surgical management of early cervical cancer: the shape of future studies. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

A Case for the Conservative Management of Stage IA Cervical Cancer. [2023]