Cervical CancerNCT02368574
Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
A study testing Class II hysterectomy in people with Cervical Cancer, run by Chinese Gynecological Oncology Group.
Trial summary
Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion). Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Class II hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Stage IA2 and small IB1 <2 cm
- Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen
- Squamous OR adenocarcinoma OR adenosquamous
- Grade 1, 2 and 3
- Lymph-vascular space invasion (LVSI): presence or absence
- Diagnosis confirmed by LEEP/cone/cervical biopsy
Show all 11Show fewer
- Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only
- Abdomino-pelvic CT scan in patients with negative LEEP-cone margins
- No contraindications to surgery
- No desire to preserve fertility
- Informed consent
Who cannot join
- High-risk histology types (clear cell, small cell etc)
- Evidence of lymph node metastasis on preoperative imaging
- Stage 1A1
- Neo-adjuvant chemotherapy
- Pregnancy
- Desire to preserve fertility
About this study
Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).
Read the detailed description
This is a 1:1 multi-center randomized trial with class II hysterectomy plus node dissection as the experimental arm, and class III hysterectomy plus pelvic node dissection as the control arm. Primary endpoints are: (1). 3-year diseases-free survival (DFS) rate; (2) the rates of treatment-related toxicity; (3) post-operation QoL (including sexual function) and (4) treatment costs. Secondary endpoints are：(1) the rates of pelvic and/or extra-pelvic relapse; (2) overall survival(OS) rate; (3) the numbers of retroperitoneal node dissection, and (4) the rates of parametrial, margins and pelvic/para-aortic nodes involvement.
- Conditions
- Cervical Cancer
- Being tested
- Class II hysterectomy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class II hysterectomyProcedure or surgery
Class II hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Class III hysterectomy Arm | No intervention | Class III hysterectomy (radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. Perivesical space and perirectal space should be opened, and the ureteral tunnel is completely separated and pushed down to the junction of ureter and urinary bladder. The uterine arteries are ligated at the level of internal iliac artery, and all the supporting ligaments and connective tissues around the uterus should be separated and abscised. The uterosacral ligament is removed near the sacrum, the cardinal ligament is removed near the pelvic wall, and the vagina is removed after the excision of peivaginal connective tissues, about 3-4cm from the cervical lesion. The pelvic lymph nodes are usually dissected at the same time. |
| Class II hysterectomy Arm | Experimental | Class II hysterectomy (modified radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. The scope of surgery is more extensive than Class I epifascial panhysterectomy, demanding the excision of more parametrium but reservation of the blood supply for distal ureter and urinary bladder. The ureter is separated from the ureteral tunnel, the vesicouterine ligament should be intact, and 1/2 uterosacral ligament and 1cm vagina are excised. The pelvic lymph nodes are usually dissected at the same time. Receives: Procedure: Class II hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival (DFS) rate
Measured: up to 4 years
Secondary outcomes (7)
Treatment-related toxicity
Measured: up to 4 years
Post-operation quality of life
Measured: up to 4 years
Cost effective
Measured: up to 4 years
Pelvic and/or extra-pelvic relapse rate
Measured: up to 4 years
Overall survival
Measured: up to 4 years
Node number involved in retroperitoneal node dissection
Measured: up to 4 years
Rates of parametrial, margins and pelvic/para-aortic nodes involvement
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Gynecological Oncology Group
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368574
- Sponsor's protocol ID
- CGOG-001
- Status last verified
- Feb 2015
- First submitted
- 18 Jan 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sun H, Cao D, Shen K, Yang J, Xiang Y, Feng F, Wu L, Zhang Z, Ling B, Song L. Piver Type II vs. Type III Hysterectomy in the Treatment of Early-Stage Cervical Cancer: Midterm Follow-up Results of a Randomized Controlled Trial. Front Oncol. 2018 Nov 28;8:568. doi: 10.3389/fonc.2018.00568. eCollection 2018.
PubMed 30555800
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
- ClinicalTrials.gov ID
- NCT02368574
- Acronym / sponsor ID
- CGOG-001
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese Gynecological Oncology GroupOther government
- Study start
- Mar 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).
Detailed description
This is a 1:1 multi-center randomized trial with class II hysterectomy plus node dissection as the experimental arm, and class III hysterectomy plus pelvic node dissection as the control arm. Primary endpoints are: (1). 3-year diseases-free survival (DFS) rate; (2) the rates of treatment-related toxicity; (3) post-operation QoL (including sexual function) and (4) treatment costs. Secondary endpoints are：(1) the rates of pelvic and/or extra-pelvic relapse; (2) overall survival(OS) rate; (3) the numbers of retroperitoneal node dissection, and (4) the rates of parametrial, margins and pelvic/para-aortic nodes involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Class III hysterectomy Arm | No intervention | –Class III hysterectomy (radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. Perivesical space and perirectal space should be opened, and the ureteral tunnel is completely separated and pushed down to the junction of ureter and urinary bladder. The uterine arteries are ligated at the level of internal iliac artery, and all the supporting ligaments and connective tissues around the uterus should be separated and abscised. The uterosacral ligament is removed near the sacrum, the cardinal ligament is removed near the pelvic wall, and the vagina is removed after the excision of peivaginal connective tissues, about 3-4cm from the cervical lesion. The pelvic lymph nodes are usually dissected at the same time. |
| Class II hysterectomy Arm | Experimental | Procedure: Class II hysterectomyClass II hysterectomy (modified radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. The scope of surgery is more extensive than Class I epifascial panhysterectomy, demanding the excision of more parametrium but reservation of the blood supply for distal ureter and urinary bladder. The ureter is separated from the ureteral tunnel, the vesicouterine ligament should be intact, and 1/2 uterosacral ligament and 1cm vagina are excised. The pelvic lymph nodes are usually dissected at the same time. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Stage IA2 and small IB1 <2 cm
- Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen
- Squamous OR adenocarcinoma OR adenosquamous
- Grade 1, 2 and 3
- Lymph-vascular space invasion (LVSI): presence or absence
Key exclusion criteria (6 listed)
- High-risk histology types (clear cell, small cell etc)
- Evidence of lymph node metastasis on preoperative imaging
- Stage 1A1
- Neo-adjuvant chemotherapy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Class II hysterectomyClass II hysterectomy | Procedure or surgery | Class II hysterectomy Arm |
Primary outcome
3-year disease-free survival (DFS) rate
Time frame: up to 4 years
7 secondary outcomes
Treatment-related toxicity
Time frame: up to 4 years
Post-operation quality of life
Time frame: up to 4 years
Cost effective
Time frame: up to 4 years
Pelvic and/or extra-pelvic relapse rate
Time frame: up to 4 years
Overall survival
Time frame: up to 4 years
Node number involved in retroperitoneal node dissection
Time frame: up to 4 years
Rates of parametrial, margins and pelvic/para-aortic nodes involvement
Time frame: up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Derived from this study: PubMed 30555800Sun H, Cao D, Shen K, Yang J, Xiang Y, Feng F, Wu L, Zhang Z, Ling B, Song L. Piver Type II vs. Type III Hysterectomy in the Treatment of Early-Stage Cervical Cancer: Midterm Follow-up Results of a Randomized Controlled Trial. Front Oncol. 2018 Nov 28;8:568. doi: 10.3389/fonc.2018.00568. eCollection 2018.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Class II hysterectomy in people with Cervical Cancer, run by Chinese Gynecological Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (DFS) rate (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.