Less Invasive Surgery for Early Stage Cervical Cancer

Not currently recruiting at 24 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a less invasive surgery for patients with early-stage cervical cancer, potentially leading to fewer side effects and quicker recovery. It focuses on conservative surgery, including procedures like lymph node assessment and possibly a hysterectomy if future fertility isn't a concern. The trial suits those with stage IA2 or IB1 cervical cancer, tumors 2 cm or smaller, and no signs of cancer spreading. Participants must have specific types of cervical cancer confirmed and be willing to sign a consent form. As an unphased trial, it offers patients the chance to contribute to innovative surgical approaches that could enhance future treatment options.

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 prior data suggests that this conservative surgery is safe for early stage cervical cancer?

Research has shown that conservative surgery for early-stage, low-risk cervical cancer is generally safe and effective. This surgery is less invasive, involving smaller cuts, which may lead to quicker recovery and fewer side effects. One study found that this surgery is not only safe but also feasible for patients with this type of cancer. Another study demonstrated that patients who underwent conservative surgery had good long-term survival rates, with 93.9% of those who had a simple hysterectomy living for at least 7 years. Overall, evidence suggests that conservative surgery is well-tolerated and a safe option for those with early-stage cervical cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about conservative surgery for early-stage cervical cancer because it aims to be less invasive while still being effective. Unlike traditional surgeries that often involve extensive removal of tissues, this approach focuses on precise lymphatic mapping and sentinel lymph node biopsy. This means less tissue is removed, potentially preserving fertility and leading to a quicker recovery. This technique not only reduces the surgical footprint but also aligns with the growing trend towards personalized, patient-centered care.

What evidence suggests that conservative surgery is effective for early stage cervical cancer?

Research shows that conservative surgery, which participants in this trial will undergo, might be a good option for treating early-stage cervical cancer. Studies have found it to be as safe and effective as more extensive surgeries, with similar survival rates. Being less invasive, conservative surgery may cause fewer side effects and allow for quicker recovery. In some studies, patients who underwent this type of surgery experienced good results and maintained their quality of life. This approach could be especially helpful for women who wish to preserve their ability to have children. ^{2 4 6 7 8}

Who Is on the Research Team?

Kathleen M Schmeler

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

Patients unwilling or unable to provide informed consent for the study

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

Presence of LVSI

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12248819/

Current Updates on Surgical Management of Patients with ... The results demonstrated that minimally invasive surgery was associated with worse disease-free and overall survival, leading to guidelines ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24004894

ConCerv: a prospective trial of conservative surgery for low ... The objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4260451/

Conservative management of early stage cervical cancer Multiple studies have reported that radical trachelectomy is feasible, safe and has equivalent disease-free and overall survival rates when compared to radical ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009082582500808X

Oncologic outcomes of minimally invasive surgery vs. ... This study compared the oncologic outcomes of MIS and abdominal hysterectomy in patients with low-risk, early-stage cervical cancer, based on the SHAPE trial ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01048853

Conservative Surgery in Treating Patients With Low-Risk ... Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery. Detailed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11091289/

Efficacy and safety analysis of non-radical surgery for early ... This study aims to conduct an in-depth evaluation of the effectiveness and safety of non-radical surgery as an alternative treatment for patients with early- ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834115

Long-Term Survival in Patients With Low-Risk Cervical ... This cohort study assesses long-term survival and postoperative metrics in patients with early-stage cervical carcinoma who underwent simple ...

8. cancertherapyadvisor.com cancertherapyadvisor.com/news/conservative-surgery-low-risk-cervical-cancer/

Data Support Conservative Surgery for Low-Risk Cervical ... The 7-year survival rate was 93.9% in patients who underwent simple hysterectomy and 95.3% in patients who underwent radical or modified radical ...