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Less Invasive Surgery for Early Stage Cervical Cancer

N/A

Waitlist Available

Led By Kathleen M Schmeler

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Imaging with positron emission tomography (PET) scan, computed tomography (CT) scan of the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment

International Federation of Gynecology and Obstetrics (FIGO) stage IA2 or IB1 disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial studies a less invasive type of surgery for early stage cervical cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include typical surgical risks such as pain, infection, bleeding, or reactions to anesthesia. There might also be specific complications related to removal of lymph nodes or reproductive organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My recent scans show no signs of cancer spread.

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My cervical cancer is in the early stages (IA2 or IB1).

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My cervical cancer is confirmed as squamous cell or grade 1/2 adenocarcinoma.

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My tumor is 2 cm or smaller, confirmed by exams and imaging.

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My cervical cancer has invaded less than 10 mm into the stroma.

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My recent cervical cancer tests show no signs of invasive cancer or severe precancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of study treatment by determining the immediate failure rate, defined as residual disease in the sample hysterectomy specimen

Female Sexual Functioning Index (FSFI) Questionnaires

Functional Assessment of Cancer Therapy-Cervix [FACT-CX] Questionnaires

+5 more

Secondary outcome measures

Cervix Cancer Recurrence Rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (conservative surgery)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sentinel Lymph Node Biopsy

2004

Completed Phase 3

~330

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850