Surgical Interventions for Cervical Cancer

Not currently recruiting at 198 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Gynecologic Oncology Group

Disqualifiers: Stage IB2, Clear cell, Neuroendocrine, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate (surgical procedure)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand how surgery affects physical function and quality of life in patients with early-stage cervical cancer. It focuses on surgeries such as cone biopsy (conization), lymphadenectomy, or hysterectomy for treating stage I cervical cancer. This trial suits patients with stage IA1 under specific conditions or stage IA2 to IB1 cervical cancer (tumor size 2 cm or smaller) who have already undergone procedures like a cone biopsy. Participants must show no signs of cancer spread on recent scans. As an unphased trial, it offers patients the opportunity to contribute to valuable research that could improve 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 these surgical interventions are safe for cervical cancer patients?

Research shows that the surgical treatments studied in this trial, such as cone biopsy and lymphadenectomy, are generally safe for individuals with early-stage cervical cancer. Previous studies found that cone biopsy, which involves removing a small, cone-shaped piece of tissue from the cervix, is well-tolerated. About 80% of individuals cleared their HPV infection eight months after the procedure. Additionally, if the edges of the removed tissue are free of cancer, the risk of remaining cancer is low.

Lymphadenectomy, which involves removing lymph nodes to check for cancer spread, also appears safe and effective. Studies suggest that the results are similar whether patients undergo lymphadenectomy or a less invasive procedure called sentinel lymph node biopsy.

Overall, these surgical options have a good safety record and effectively treat early cervical cancer. However, like any surgery, they carry some risks, so it's important to weigh these against the potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical interventions for cervical cancer because they aim to refine existing surgical techniques to improve patient outcomes. Unlike traditional methods that may involve more extensive surgery, this approach focuses on less invasive procedures like cone biopsy and pelvic lymphadenectomy, which could potentially reduce recovery time and lower the risk of complications. By targeting the cancer more precisely, these techniques might also preserve more of the healthy tissue, offering a significant advantage over more radical surgeries like standard hysterectomies.

What evidence suggests that these surgical interventions are effective for cervical cancer?

This trial will evaluate different surgical interventions for cervical cancer. Studies have shown that conization, a surgery where a cone-shaped piece of tissue is removed from the cervix, can be effective for early-stage cervical cancer. Eight months after the procedure, 80% of patients cleared their HPV infection, which is often linked to cervical cancer. Additionally, about half of the women who tried to get pregnant after conization were successful. In this trial, some participants will undergo conization and pelvic lymphadenectomy. Lymphadenectomy, which involves removing lymph nodes, has also shown promising results. Research indicates that patients who underwent this procedure had a high survival rate, with no return of cancer in the lymph nodes. Both treatments have proven effective in managing early-stage cervical cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Allan L Covens

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for patients with early-stage cervical cancer (stage IA1 with LVSI+, IA2, IB1 with tumor ≤2cm). They must have had a cone biopsy or LEEP showing invasion ≤10mm and no metastasis on scans. Participants need to consent to surgery, have good performance status (0-2), and sign informed consent.

Inclusion Criteria

Patients who have met the pre-entry requirements

Patient must consent for the appropriate surgery

Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade

Exclusion Criteria

Patients with stage IA1 disease who are LVSI negative

Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm

Patients with >= stage IB2 disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy

Immediate (surgical procedure)

1 visit (in-person)

Initial Follow-up

Participants complete questionnaires at 4-6 weeks after surgery to assess quality of life and functional outcomes

4-6 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored every 3 months for 1 year, and then every 6 months for 2 years to assess long-term effects and recurrence

3 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Conization
• Quality-of-Life Assessment
• Questionnaire Administration
• Therapeutic Conventional Surgery
• Therapeutic Lymphadenectomy

Trial Overview The study focuses on the impact of surgery on physical function and quality of life in stage I cervical cancer patients. It involves assessments through questionnaires before and after surgical procedures like conization, lymphadenectomy, and other conventional surgeries.

How Is the Trial Designed?

Group I: Treatment (cone biopsy/lymphadenectomy or hysterectomy) Experimental Treatment 5 Interventions

Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.

Therapeutic Conventional Surgery is already approved in United States, European Union for the following indications:

Approved in United States as Therapeutic Conventional Surgery for:

• Resectable p16+ Locally Advanced Oropharynx Cancer

Approved in European Union as Transoral Surgical Resection for:

• HPV-positive oropharyngeal cancer

Who Is Running the Clinical Trial?

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Recruited

65,400+

GOG Foundation

Lead Sponsor

Trials

48

Recruited

18,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Neoadjuvant chemotherapy (NAC) before surgery may improve survival for cervical cancer patients with stage Ib2, while concurrent chemoradiotherapy (CCRT) has shown a significant survival benefit in advanced stages (III/IVA) with a 28%-50% reduction in death risk based on five large randomized clinical trials.

A meta-analysis of 19 RCTs involving 4580 patients indicated that CCRT significantly improves overall survival and progression-free survival, leading to its recommendation as the standard therapy for advanced cervical cancer in the U.S., although further research is needed to optimize treatment protocols for different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoradiotherapy for uterine cancer: current status and perspectives. Kuzuya, K.[2012]

Robotic radical hysterectomy (RRH) resulted in a significantly lower complication rate (9.65%) compared to laparoscopic radical hysterectomy (LRH) (17.59%), indicating that RRH may be a safer surgical option for cervical cancer patients.

Both RRH and LRH showed similar overall survival rates and progression-free survival times, suggesting that while RRH may reduce complications, it does not compromise long-term outcomes compared to LRH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of robotic vs laparoscopic radical hysterectomy for cervical cancer. Chen, L., Liu, LP., Wen, N., et al.[2020]

In a study involving 631 women with early cervical cancer, minimally invasive radical hysterectomy showed a similar overall incidence of intraoperative and postoperative adverse events compared to open radical hysterectomy, indicating comparable safety profiles for both surgical approaches.

Despite the similar rates of adverse events, the trial was suspended due to an increased risk of recurrence and death in the minimally invasive surgery group, highlighting potential concerns regarding long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial. Obermair, A., Asher, R., Pareja, R., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5649875/

Outcomes of Laser Conization for Cervical Intraepithelial ... Positive margins increased with the extent of disease and were observed in 5.5%, 8.9% and 16.4% patients with CIN 2, CIN 3 and MIC, respectively, while residual ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10701928/

Post-conization surveillance in an organized cervical ... Eight months post-conization, 80% of the individuals had cleared their HPV infection. In a mean follow-up time of 32.1 months post-conization, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825000745

Evaluation of efficacy and fertility after nonradical surgical ... Of 31 patients attempting pregnancy after cone biopsy, 16 pregnancies were achieved. •. 3 recurrences occurred in the cervix, in the cone biopsy group, all were ...

4. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-025-03769-1

Outcomes following conization and factors on HPV regression ... A total of 400 patients aged 18 to 35 were included, with 354 (88.5%) undergoing cervical biopsy and 92 (23%) undergoing cervical conization.

5. nature.com nature.com/articles/s41598-021-02635-y

Clinical effects of cervical conization with positive margins ... The aim of this study was to investigate the clinical outcomes of positive margins at conization in cervical cancer.

6. nature.com nature.com/articles/s41598-020-75512-9

Oncologic and obstetric outcomes after conization for ... Conization is safe for young women with AIS, stage IA1 SCC and ADC who desire future fertility, and the associated HSIL recurrence rate is low.

7. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/23381-cone-biopsy

Cone Biopsy (Conization): Procedure, Recovery & Results Cone biopsy is safe but comes with risks. Talk to your ... Yes, a cone biopsy can remove early-stage cervical cancer. Results ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9807369/

Comparison of the safety between cervical conization and ... Our data and results from other studies suggest that the risk of residual lesions and residual invasive cancer was low after CC provided the margin was negative ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24020322

Cervical conization and lymph node assessment for early ... The live birth rate was 85% and 16 (94%) of 17 patients had live births at term. Conclusion. Cervical conization with SLN biopsy appears to be a safe treatment ...