Cervical CancerPALANCT04392895
Para Aortic Lymphadenectomy : Always ?
An observational study of Cervical Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Para Aortic Lymphadenectomy (PAL) by laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 30 Jun 2020
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced cervical cancer, who had undergone a PAL after a negative paraaortic PET CT, between January 2015 and december 2019
Who may be able to join
- Patients with :
- locally advanced cervical cancer,
- who undergone PAL
- with pre operative PET CT, between January 2015 and december 2019
Who cannot join
- patients aged under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.
Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.
- Conditions
- Cervical Cancer
- Being tested
- Para Aortic Lymphadenectomy (PAL) by laparoscopy
- Keywords
- Locally advanced cervical cancer, more than IB3 stage FIGO 2018, Para aortic lymphadenectomy, Laparoscopy, PET/CT
- 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.
Para Aortic Lymphadenectomy (PAL) by laparoscopyProcedure or surgery
Para Aortic Lymphadenectomy (PAL) by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Patients with locally advanced cervical cancer | Patients with locally advanced cervical cancer, who had undergone a PAL Receives: Procedure: Para Aortic Lymphadenectomy (PAL) by laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.
The intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions.
Measured: 1 day
Secondary outcomes (1)
morbidity of PAL
morbidity of PAL
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jan 2017
- Primary completion29 May 2020
- Study completion30 Jun 2020
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha DURAES, Md, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392895
- Sponsor's protocol ID
- RECHMPL20_0296
- Acronym
- PALA
- Status last verified
- Jul 2020
- First submitted
- 13 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.
- ClinicalTrials.gov ID
- NCT04392895
- Acronym / sponsor ID
- PALA / RECHMPL20_0296
- Conditions
- Cervical Cancer
- Keywords
- Locally advanced cervical cancer, more than IB3 stage FIGO 2018, Para aortic lymphadenectomy, Laparoscopy, PET/CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 May 2020 (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.
Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with locally advanced cervical cancer | – | Procedure: Para Aortic Lymphadenectomy (PAL) by laparoscopyPatients with locally advanced cervical cancer, who had undergone a PAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced cervical cancer, who had undergone a PAL after a negative paraaortic PET CT, between January 2015 and december 2019
Key inclusion criteria (4 listed)
- Patients with :
- locally advanced cervical cancer,
- who undergone PAL
- with pre operative PET CT, between January 2015 and december 2019
Key exclusion criteria (1 listed)
- patients aged under 18
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 |
|---|---|---|
| Para Aortic Lymphadenectomy (PAL) by laparoscopyPara Aortic Lymphadenectomy (PAL) by laparoscopy | Procedure or surgery | Patients with locally advanced cervical cancer |
Primary outcome
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.
Time frame: 1 day
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes. The intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions.
1 secondary outcome
morbidity of PAL
Time frame: 1 day
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 29 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Cervical Cancer
RecruitingPhase 3
Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Advanced Head and Neck Cancer Who Cannot Receive Cisplatin
Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma
Active, not recruitingPhase 2
Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
RecruitingPhase 3
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
Oral Cavity Carcinoma, Flap
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.
Martha DURAES, Md principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 1 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 29 Jul 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 France. 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.
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?
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes. (time frame: 1 day). 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 29 Jul 2020.