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Hysterectomy Techniques for Cervical Cancer (SHAPE Trial)

N/A
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix diagnosed by LEEP, cone, or cervical biopsy and reviewed by local gynecological pathologist
Patients who have undergone physical examination, recto-vaginal examination, and visualization of the cervix by speculum or colposcopic examination
Must not have
Patients with FIGO 1A1 disease
History of other malignancies except specified exceptions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a hysterectomy is as effective as a radical hysterectomy in preventing the return of cervical cancer, with the hope that it will have fewer side-effects.

Who is the study for?
Women over 18 with low-risk early-stage cervical cancer confirmed by biopsy, who are not pregnant, have no plans for radiation/chemotherapy post-surgery, and do not wish to preserve fertility. They must be fit for surgery without a history of other malignancies (except certain treated cancers) or evidence of lymph node metastasis.
What is being tested?
The study is comparing the effectiveness of two surgical procedures: radical hysterectomy versus simple hysterectomy combined with pelvic lymph node dissection in preventing the return of cervical cancer. It also examines if the simpler surgery results in fewer side effects.
What are the potential side effects?
Potential side effects may include pain, bleeding, infection at the surgery site, urinary problems, bowel issues and sexual dysfunction. Long-term risks could involve impacts on bladder and bowel function as well as changes related to sexual health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cervical cancer diagnosis was confirmed through a biopsy.
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I have had a full pelvic exam, including a visual check of my cervix.
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I am 18 years old or older.
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I am okay with surgery that may affect my ability to have children.
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My cervical cancer is early-stage and considered low-risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is early-stage cervical cancer (FIGO 1A1).
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I have had cancer before, but it fits the exceptions.
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My cancer has spread to my lymph nodes.
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I have had or will have chemotherapy before surgery.
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I am scheduled for additional treatment after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pelvic recurrence rate at 3 years
Secondary study objectives
Efficacy comparison between treatment arms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Simple HysterectomyExperimental Treatment1 Intervention
Group II: Radical HysterectomyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
131 Previous Clinical Trials
68,847 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,385 Previous Clinical Trials
26,515,235 Total Patients Enrolled
Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom GermanyUNKNOWN

Media Library

Radical Hysterectomy + pelvic lymph node dissection Clinical Trial Eligibility Overview. Trial Name: NCT01658930 — N/A
Cervical Cancer Research Study Groups: Radical Hysterectomy, Simple Hysterectomy
Cervical Cancer Clinical Trial 2023: Radical Hysterectomy + pelvic lymph node dissection Highlights & Side Effects. Trial Name: NCT01658930 — N/A
Radical Hysterectomy + pelvic lymph node dissection 2023 Treatment Timeline for Medical Study. Trial Name: NCT01658930 — N/A
~55 spots leftby Nov 2025
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