Cervical CancerPhase 2NCT03295526
Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer
A Phase 2 study testing Lymph nodes debulking surgery. in people with Cervical Cancer, run by Fudan University at 1 site in China.
Trial summary
Test name: Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3 years Test objectives： The primary goal：The overall therapeutic effect of patients with selective lymphadenectomy was not… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Lymph nodes debulking surgery.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Sep 2022
- Phase
- Phase 2
- 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
- histology confirmed as cervical adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma.
- histological grading of cervical cancer is 1, 2, 3 or not.
- patients in the group must have no reproductive function requirements.
- Patients must be ≥ 18 years of age.
- preoperative: pelvic CT / MR or PET / CT suggest pelvic lymph node enlargement. Intraoperative: Patients with pelvic lymph node metastasis confirmed by freezing.
- Signed informed consent.
- Surgery should be completed within 4 weeks after the first diagnosis.
- patients can receive treatment and follow-up.
Who cannot join
- abdominal CT, PET / CT suggest that patients with para aortic lymph node metastasis.
- other history of the tumor, but does not include: received appropriate treatment of non-melanoma skin cancer, has been cured of other solid tumors, has been cured or non Hodgkin's lymphoma and Hodgkin's lymphoma 5 years without recurrence.
- Those who have received or will receive neoadjuvant chemotherapy.
- patients with preoperative limb lymphedema or lower extremity venous and lymphatic reflux disorders.
- pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan university
Shanghai, Shanghai Municipality, 021
Liang shanhui, Dr, 008618616890863, dr_liangshanhui@163.com
About this study
Official title: Study on Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer
Test name:
Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3 years Test objectives： The primary goal：The overall therapeutic effect of patients with selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy.
Read more
Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of postoperative lower limb lymphedema.
The study was designed for prospective, randomized, controlled clinical trials. The number of subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The control group was treated with systematic pelvic lymph node dissection group.
Follow-up time: 3 years Sample size: 200 cases
End of the trial:
Primary end-poin:t three-year survival (overall survival, progression-free survival) Secondary end point: lower limb lymph node lymphedema
Read the detailed description
Overall objective For cervical cancer patients with confirmed lymph node metastasis by intraoperative frozen pathology, the overall treatment effect of radical hysterectomy and selective enlarged lymph node dissection is not inferior to systematic pelvic lymphadenectomy and can reduce postoperative lower limb lymphedema incidence and severity.
- The purpose of this study
- to assess whether the progression free survival of patients with selective enlarged pelvic lymph node resection is better than patients with systematic pelvic lymph node dissection.
- to evaluate differences of the incidence and severity of lymphedema between the two group patients using Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.
- Preoperative evaluation LEEP, conization or biopsy Vagino-recto-abdominal examination + Vaginal / vaginal colposcopy examination History of Medical, surgical and childbearing Complications Physical condition Height and weight History of smoking Pregnancy test Chest X-ray or chest CT or general PET/CT Abdominal CT or general PET/CT Pelvic MRI/CT or general PET/CT
3.Protocol Patients with stage IB-IIa cervical cancer were randomly divided into two groups(Control group and Experimental group).Frozen pathological examination will be performed during the operation, and patients with positive lymph node metastasis will undergo radical hysterectomy and systematic pelvic lymphadenectomy or radical hysterectomy and selective enlarged lymph node dissection according to the patient's group.
- Postoperative adjuvant therapy All patients with pelvic lymph node metastasis are required to receive DDP based concurrent chemoradiotherapy.
5.Efficacy evaluation Overall survival (OS): The period from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).
Progression free survival (PFS): The duration from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.
Assessment of lymphedema in lower extremities: Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology were used :
Stage 0 Subclinical with possible clinical evolution Stage I Edema regressing with treatments with positive pitting test Stage II Edema partially regressing with treatments with negative pitting test Stage III Elephantiasis with cutaneous complications and recurrent infections.
- Follow up The patients were followed up every 3 months for the first year, every 4 months for the second year and every 6 months from the third year.
In addition to routine oncologic follow-up, the stage of patients̛ lower extremity lymphedema should also be evaluated.
- Conditions
- Cervical Cancer
- Being tested
- Lymph nodes debulking surgery.
- Keywords
- Cervical Cancer, Lymph nodes debulking surgery
- 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.
Lymph nodes debulking surgery.Procedure or surgery
Radical hysterectomy and selective enlarged lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy |
| Experimental group | Experimental | IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection. Receives: Procedure: Lymph nodes debulking surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The period(months) from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).
Measured: 3 year
Secondary outcomes (2)
Progression-Free-Survival (PFS)
The period(months) from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.
Measured: 3 year
Lower extremities lymphedema
Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Wu MD, Fudan University
- Investigators
- Xiaohua WU, PhD & MD, Principal investigator, Fudan university shanghai cancer center, Deparment of gynecologic oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295526
- Sponsor's protocol ID
- STCSM2016-6-17-1.1
- Status last verified
- Aug 2020
- First submitted
- 12 Sep 2017
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer
- ClinicalTrials.gov ID
- NCT03295526
- Acronym / sponsor ID
- STCSM2016-6-17-1.1
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Lymph nodes debulking surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 Sep 2017 (actual)
- 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.
Test name:
Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3 years Test objectives： The primary goal：The overall therapeutic effect of patients with selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy.
Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of postoperative lower limb lymphedema.
The study was designed for prospective, randomized, controlled clinical trials. The number of subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The control group was treated with systematic pelvic lymph node dissection group.
Follow-up time: 3 years Sample size: 200 cases
End of the trial:
Primary end-poin:t three-year survival (overall survival, progression-free survival) Secondary end point: lower limb lymph node lymphedema
Detailed description
Overall objective For cervical cancer patients with confirmed lymph node metastasis by intraoperative frozen pathology, the overall treatment effect of radical hysterectomy and selective enlarged lymph node dissection is not inferior to systematic pelvic lymphadenectomy and can reduce postoperative lower limb lymphedema incidence and severity.
- The purpose of this study
- to assess whether the progression free survival of patients with selective enlarged pelvic lymph node resection is better than patients with systematic pelvic lymph node dissection.
- to evaluate differences of the incidence and severity of lymphedema between the two group patients using Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.
- Preoperative evaluation LEEP, conization or biopsy Vagino-recto-abdominal examination + Vaginal / vaginal colposcopy examination History of Medical, surgical and childbearing Complications Physical condition Height and weight History of smoking Pregnancy test Chest X-ray or chest CT or general PET/CT Abdominal CT or general PET/CT Pelvic MRI/CT or general PET/CT
3.Protocol Patients with stage IB-IIa cervical cancer were randomly divided into two groups(Control group and Experimental group).Frozen pathological examination will be performed during the operation, and patients with positive lymph node metastasis will undergo radical hysterectomy and systematic pelvic lymphadenectomy or radical hysterectomy and selective enlarged lymph node dissection according to the patient's group.
- Postoperative adjuvant therapy All patients with pelvic lymph node metastasis are required to receive DDP based concurrent chemoradiotherapy.
5.Efficacy evaluation Overall survival (OS): The period from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).
Progression free survival (PFS): The duration from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.
Assessment of lymphedema in lower extremities: Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology were used :
Stage 0 Subclinical with possible clinical evolution Stage I Edema regressing with treatments with positive pitting test Stage II Edema partially regressing with treatments with negative pitting test Stage III Elephantiasis with cutaneous complications and recurrent infections.
- Follow up The patients were followed up every 3 months for the first year, every 4 months for the second year and every 6 months from the third year.
In addition to routine oncologic follow-up, the stage of patients̛ lower extremity lymphedema should also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy |
| Experimental group | Experimental | Procedure: Lymph nodes debulking surgery.IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histology confirmed as cervical adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma.
- histological grading of cervical cancer is 1, 2, 3 or not.
- patients in the group must have no reproductive function requirements.
- Patients must be ≥ 18 years of age.
- preoperative: pelvic CT / MR or PET / CT suggest pelvic lymph node enlargement. Intraoperative: Patients with pelvic lymph node metastasis confirmed by freezing.
Key exclusion criteria (5 listed)
- abdominal CT, PET / CT suggest that patients with para aortic lymph node metastasis.
- other history of the tumor, but does not include: received appropriate treatment of non-melanoma skin cancer, has been cured of other solid tumors, has been cured or non Hodgkin's lymphoma and Hodgkin's lymphoma 5 years without recurrence.
- Those who have received or will receive neoadjuvant chemotherapy.
- patients with preoperative limb lymphedema or lower extremity venous and lymphatic reflux disorders.
- pregnant women
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 |
|---|---|---|
| Lymph nodes debulking surgery.Radical hysterectomy and selective enlarged lymph node dissection | Procedure or surgery | Experimental group |
Primary outcome
Overall survival (OS)
Time frame: 3 year
The period(months) from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).
2 secondary outcomes
Progression-Free-Survival (PFS)
Time frame: 3 year
Lower extremities lymphedema
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- 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.
Xiaohua WU, PhD & MD principal investigator
Fudan university shanghai cancer center, Deparment of gynecologic oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lymph nodes debulking surgery. in people with Cervical Cancer, run by Fudan University at 1 site in China.
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 8 inclusion and 5 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shanhui Liang, Dr (008618616890863, dr_lianshanhui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2020.