Uterine Cervical NeoplasmsLESSERNCT02613286
LESs Surgical Radicality for EaRly Stage Cervical Cancer
A study testing Extrafascial Hysterectomy and Modified radical hysterectomy in people with Uterine Cervical Neoplasms, run by Hospital de Câncer de Pernambuco.
Trial summary
This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage IA2-IB1… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Extrafascial Hysterectomy and Modified radical hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2015to 10 May 2022
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix by LEEP, cone or cervical biopsy;
- Aged between 18 and 70 years;
- performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
- FIGO early stage IA2-IB1 ≤ 2cm;
- Appropriated cardio-respiratory, hepato-renal and hematological reserves; and
- Signing of the Consent Form.
Who cannot join
- Limiting systemic comorbidities including neuro-psychiatric disorders or obesity;
- Apparent or confirmed uncontrolled infections;
- Other malignancies in activity;
- Previous radiation or chemotherapy treatment or major pelvic surgery;
- History of drug allergies, and pregnancy or breast feeding; and
- Evidence of more extensive disease at the time of surgery.
About this study
Official title: A Proof of Concept Non-inferiority Trial Evaluating the Safety and Efficacy of Extrafascial Hysterectomy Plus Pelvic Lymph-node Dissection in Patients With Stage IA2-IB1 Cervical Cancer ≤ 2cm
This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of extrafascial hysterectomy compared with modified radical hysterectomy, both plus level 1 pelvic lymph-node dissection, in patients with early stage IA2-IB1 cervical cancer ≤ 2cm. The experimental procedure will be considered to be promising for treatment of stage IA2-IB1 cervical cancer ≤ 2cm if the Bayesian posterior probability of "the difference of the 3-y DFS rate is less than the non-inferiority margin of 5%" is at least 50%. Thus, using this proof of concept design, the planned sample size is 40, with 20 cases per arm, which provides 72% chance of satisfying the above criteria, under the hypothesis that the lowest 3-y DFS rate in each arm is 90%. As required, adjuvant therapy will include cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Extrafascial Hysterectomy, Modified radical 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.
Extrafascial HysterectomyProcedure or surgery
Hysterectomy plus Pelvic Lymph-Node Dissection
Modified radical hysterectomyProcedure or surgery
Hysterectomy plus Pelvic Lymph-Node Dissection
| Study group | Role | What they receive |
|---|---|---|
| Extrafascial Hysterectomy | Experimental | Type A hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification. Receives: Procedure: Extrafascial Hysterectomy |
| Modified radical hysterectomy | Active comparator | Type B2 hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification. Receives: Procedure: Modified radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (3-y DFS)
Time from surgery to recurrence
Measured: 3 years
Secondary outcomes (4)
Treatment-related adverse events (surgical)
Surgical morbidity and mortality
Measured: 90 days
Patient reported QoL
QoL according to EORTC C30 questionnaire (v3.0)
Measured: Base-line and 6 months.
Rates of using adjuvant therapy
Cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria
Measured: 90 days
Overall survival (3-y OS)
Time from surgery to death of any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2018
- Study completion10 May 2022
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 Uterine Cervical NeoplasmsStudies 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
- Model description
- Proof of concept design (phase II non-inferiority trial)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Câncer de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Maceió, Professor Fernando Figueira Integral Medicine Institute
- Responsible party
- Principal investigator, Thales Paulo Batista, Hospital de Câncer de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613286
- Sponsor's protocol ID
- CAAE: 42981715.7.0000.5205
- Other IDs
- U1111-1176-6929
- Acronym
- LESSER
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2015
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Carneiro VCG, Batista TP, Andrade MR, Barros AV, Camara LHLD, Ramalho NM, Lucena MA, Fontao DFS, Tancredi R, Silva Junior TC, Bezerra ALR, Baiocchi G. Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer </=2 cm (LESSER). Int J Gynecol Cancer. 2023 Apr 3;33(4):498-503. doi: 10.1136/ijgc-2022-004092.
PubMed 36696980
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Non-inferiority Trial Evaluating the Safety and Efficacy of Extrafascial Hysterectomy Plus Pelvic Lymph-node Dissection in Patients With Stage IA2-IB1 Cervical Cancer ≤ 2cm
- ClinicalTrials.gov ID
- NCT02613286
- Acronym / sponsor ID
- LESSER / CAAE: 42981715.7.0000.5205
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de Câncer de PernambucoUniversity, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Maceió, Professor Fernando Figueira Integral Medicine Institute
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 24 Nov 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.
This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of extrafascial hysterectomy compared with modified radical hysterectomy, both plus level 1 pelvic lymph-node dissection, in patients with early stage IA2-IB1 cervical cancer ≤ 2cm. The experimental procedure will be considered to be promising for treatment of stage IA2-IB1 cervical cancer ≤ 2cm if the Bayesian posterior probability of "the difference of the 3-y DFS rate is less than the non-inferiority margin of 5%" is at least 50%. Thus, using this proof of concept design, the planned sample size is 40, with 20 cases per arm, which provides 72% chance of satisfying the above criteria, under the hypothesis that the lowest 3-y DFS rate in each arm is 90%. As required, adjuvant therapy will include cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Proof of concept design (phase II non-inferiority trial)
| Arm | Type | Receives |
|---|---|---|
| Extrafascial Hysterectomy | Experimental | Procedure: Extrafascial HysterectomyType A hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification. |
| Modified radical hysterectomy | Active comparator | Procedure: Modified radical hysterectomyType B2 hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix by LEEP, cone or cervical biopsy;
- Aged between 18 and 70 years;
- performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
- FIGO early stage IA2-IB1 ≤ 2cm;
- Appropriated cardio-respiratory, hepato-renal and hematological reserves; and
Key exclusion criteria (6 listed)
- Limiting systemic comorbidities including neuro-psychiatric disorders or obesity;
- Apparent or confirmed uncontrolled infections;
- Other malignancies in activity;
- Previous radiation or chemotherapy treatment or major pelvic surgery;
- History of drug allergies, and pregnancy or breast feeding; and
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 |
|---|---|---|
| Extrafascial HysterectomyHysterectomy plus Pelvic Lymph-Node Dissection | Procedure or surgery | Extrafascial Hysterectomy |
| Modified radical hysterectomyHysterectomy plus Pelvic Lymph-Node Dissection | Procedure or surgery | Modified radical hysterectomy |
Primary outcome
Disease Free Survival (3-y DFS)
Time frame: 3 years
Time from surgery to recurrence
4 secondary outcomes
Treatment-related adverse events (surgical)
Time frame: 90 days
Patient reported QoL
Time frame: Base-line and 6 months.
Rates of using adjuvant therapy
Time frame: 90 days
Overall survival (3-y OS)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 36696980Carneiro VCG, Batista TP, Andrade MR, Barros AV, Camara LHLD, Ramalho NM, Lucena MA, Fontao DFS, Tancredi R, Silva Junior TC, Bezerra ALR, Baiocchi G. Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer </=2 cm (LESSER). Int J Gynecol Cancer. 2023 Apr 3;33(4):498-503. doi: 10.1136/ijgc-2022-004092.
- Individual participant dataSharing planned: No
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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 Extrafascial Hysterectomy and Modified radical hysterectomy in people with Uterine Cervical Neoplasms, run by Hospital de Câncer de Pernambuco.
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 6 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: finished, as of the sponsor's last update on 15 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease Free Survival (3-y DFS) (time frame: 3 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 NCT02613286, 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 15 Jun 2022.