Surgical Interventions for Cervical Cancer

Recruiting at 185 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)

224 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.

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 for cervical cancer?

The surgical management of cervical cancer, including procedures like radical hysterectomy and lymphadenectomy, has shown 5-year survival rates of 75% to 90% for certain stages, which is comparable to radiotherapy. Advances in surgical techniques have improved survival and quality of life for women with cervical cancer. ^{1 2 3 4 5}

Is surgical intervention for cervical cancer generally safe?

Surgical interventions for cervical cancer, including minimally invasive and open radical hysterectomy, have been studied for safety. Evidence suggests that less radical surgeries can be safe for smaller tumors, and robotic surgery may offer safety benefits compared to traditional methods. However, ongoing studies are needed to confirm these findings. ^{6 7 8 9 10}

How does the treatment Therapeutic Conventional Surgery differ from other treatments for cervical cancer?

Therapeutic Conventional Surgery, also known as Transoral Surgical Resection, is unique because it offers a minimally invasive approach that can preserve fertility in women of reproductive age, unlike traditional radical hysterectomy. This approach minimizes surgical complications while maintaining effective outcomes, providing an alternative to more invasive surgeries or chemoradiation. ^{2 4 7 11 12}

Research Team

Allan L Covens

Principal Investigator

NRG Oncology

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

European Society of Gynaecological Oncology quality indicators for surgical treatment of cervical cancer. [2020]

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

Surgical management of stage IB-IIA cervical carcinoma. [2019]

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

Surgical management of advanced and recurrent cervical cancer. [2022]

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

Surgical management of cervical carcinoma. [2012]

5. Japan pubmed.ncbi.nlm.nih.gov

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

6. Japan pubmed.ncbi.nlm.nih.gov

Retrospective comparison of clinical outcome between radiotherapy alone and surgery plus postoperative radiotherapy in the treatment of stages IB-IIB cervical squamous cell carcinoma. [2019]

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

New developments in the surgical therapy of cervical carcinoma. [2008]

8. United States 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. [2021]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Tailoring radicality in early cervical cancer: how far can we go? [2020]

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

Superiority of robotic surgery for cervical cancer in comparison with traditional approaches: A systematic review and meta-analysis. [2022]

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

Comparative analysis of robotic vs laparoscopic radical hysterectomy for cervical cancer. [2020]

12. Romania pubmed.ncbi.nlm.nih.gov

[Laparoscopy-assisted total vaginal hysterectomy with transperitoneal lymphadenectomy for early cervical cancer--surgical technique]. [2014]