Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant ChemotherapyPhase 1/2LYANANCT01724944
LYmphadenectomy After NeoAdjuvant Chemotherapy
A Phase 1/2 study testing Systematic pelvic and aortic lymphadenectomy in people with Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy
- What is being tested?
- Systematic pelvic and aortic lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2011to Feb 2013
- Phase
- Phase 1/2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Patients affected by advanced ovarian cancer (FIGO stage III-IV) who underwent > 2 to <7 cycles of neoadjuvant chemotherapy based on platinum and taxanes.
- Clinical response (instrumental and serological) complete or partial.
- Residual intra-abdominal tumor <1 cm.
- Absence of disease macroscopically evident in lymph nodes (> 1 cm)
- Life expectancy of at least 4 weeks
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- ECOG PS ≤ 2
- Adequate respiratory function, hepatic, cardiac, bone marrow and renal function (creatinine clearance> 60 mL / min according to the Cockroft formula)
- Patient psychologically able to follow the study procedures
Who cannot join
- Patients with severe impairment of lung function, or liver failure, such as not to allow access in safety in the operating room.
- Not epithelial ovarian neoplasms or borderline tumors
- Other invasive cancer in the last 5 years or signs of recurrence or activity
- Patients with intra-abdominal residual tumor> 1 cm
- Patients with the presence of bulky nodes (> 1 cm) in the intra-operative evaluation
- Diseases of the lymphatic system (including lymphatic edema of unknown origin)
Trial locations and contacts
1 site in 1 country.
Catholic University of Sacred Heart contact
Italy1 site, 1 recruiting
- Recruiting
Catholic University of Sacred Heart
Rome, Rome, 00100
Fagotti Anna, MD, PhD
Fanfani Francesco, MD
About this study
Official title: Lymphadenectomy After Neo-Adjuvant Chemotherapy in Ovarian Neoplasm
The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.
Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.
Read the detailed description
In patients with advanced ovarian cancer (FIGO stage III-IV), a percentage between 50% and 80% had lymph node metastases at diagnosis, mainly in para-aorto-caval (48 %) and iliac areas (49%). In 1988, FIGO has included lymph node metastasis in stage IIIC, although some authors argue that only node involvement constitutes a clinical course different from IIIC cancer patients with abdominal diffusion.
Although it has been demonstrated that lymphadenectomy is technically feasible and relatively safe in this subset of patients, however, it is burdened by a certain percentage of complications including limphocyst, lymphedema, hemorrhage, ranging from 6% to 45%. In addition, the actual therapeutic role is still controversial and it is not clear whether this surgical procedure should be part of the staging of these tumors. Retrospective studies have shown a benefit on overall survival in patients with ovarian cancer who underwent lymphadenectomy associated with optimal debulking (residual tumor <1 cm). In a recent publication by SEER is found that the number of lymph nodes removed during surgery for advanced ovarian cancer is an independent prognostic factor.
In the literature there is only one prospective randomized study on lymphadenectomy in advanced ovarian cancer without node lesions macroscopically observed (bulky nodes) during the first surgery. The authors reported a significant benefit in terms of disease free survival (DFS), but not in terms of overall survival (OS) in patients who underwent systematic lymphadenectomy and who had a residual tumor <1 cm. Patients with intra-abdominal residual tumor <1 cm could theoretically not benefit from a systematic lymphadenectomy since most of lymph node metastases undetectable to intraoperative assessment are smaller than 1 cm.
About 20% of ovarian cancer patients stage III-IV, however, are not operable at the time of diagnosis because of the spread of the disease. In these cases, the gold standard treatment consists of submitting the patient to Interval Debulking Surgery (IDS) after neoadjuvant chemotherapy. The prognosis of these patients compared to those who are subjected to primary surgery, with the same residual tumor after surgery, is currently a topic of controversial debate. Recently, a multicenter, randomized EORTC showed no difference in prognosis between primary surgery and Interval Debulking Surgery in a population stratified by residual tumor. There are few retrospective studies that consider the presence of lymph node metastases in patients undergoing Interval Debulking Surgery: the percentage of lymph node metastases in this subset varies from 37.5% to 75%.
The purpose of the study is to assess whether systematic pelvic and aortic lymphadenectomy should be part of standard surgical procedures in patients with ovarian cancer who underwent surgery after neoadjuvant chemotherapy with intra-abdominal residual tumor <1 cm.
All patients candidate for Interval Debulking Surgery which do not present bulky nodes at surgery and which have an intra-abdominal residual tumor <1 cm at the end of the surgery will be enrolled in the study.
The baseline assessment of patients is to perform general blood tests, CA 125, CT thorax, abdomen, pelvis, anesthetic assessment and, if eligible, the patients will be subjected to the treatment above.
The enrollment period will last for 2 years until the achieving of 65 patients as the study population. The median follow-up of 6 months for all patients for the primary objectives and a median of 36 months for the secondary objectives.
- Being tested
- Systematic pelvic and aortic lymphadenectomy
- Keywords
- Interval debulking surgery, IDS, NACT, Neoadjuvant chemotherapy, Lymphadenectomy, Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic pelvic and aortic lymphadenectomyProcedure or surgery
Pelvic lymphadenectomy dissection began at the origin of the external iliac vessels and continued caudally along the medial border of the psoas muscle, with the lower limit of the external iliac lymphadenectomy being represented by the deep inferior epigastric vessels. The lateral boundaries of lymphadenectomy were delineated superficially by the fascia covering the psoas muscle and deeply by the fascia covering the internal obturator and levator ani muscles. Lymph nodes along the external iliac vessels were removed en bloc with those adjacent to the common iliac vessels. Aortic lymphadenectomy dissection began at the aortic bifurcation by removing the superficial intercavoaortic, precaval, and preaortic nodal groups. Lymph nodes located lateral to the vena (i.e., paracaval nodal group) were separated from the vena cava, then removed en bloc. Lymph nodes behind the vena cava are removed if enlarged. Removal of the lateroaortic nodes was performed up to the level of the left renal vein.
| Study group | Role | What they receive |
|---|---|---|
| Systematic Lymphadenectomy | Experimental | Not described Receives: Procedure: Systematic pelvic and aortic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of positive lymph nodes after neoadjuvant chemotherapy
Measured: 6 months
Evaluation of complications related to the surgical procedure
Measured: 6 months
Secondary outcomes (2)
Evaluation of disease-free interval (DFS)
Measured: 36 months
Assessment of overall survival (OS)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant ChemotherapyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724944
- Sponsor's protocol ID
- LYANA
- Acronym
- LYANA
- Status last verified
- Nov 2012
- First submitted
- 8 Nov 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphadenectomy After Neo-Adjuvant Chemotherapy in Ovarian Neoplasm
- ClinicalTrials.gov ID
- NCT01724944
- Acronym / sponsor ID
- LYANA / LYANA
- Keywords
- Interval debulking surgery, IDS, NACT, Neoadjuvant chemotherapy, Lymphadenectomy, Ovarian cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (estimated)
- First posted
- 12 Nov 2012 (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.
The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.
Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.
Detailed description
In patients with advanced ovarian cancer (FIGO stage III-IV), a percentage between 50% and 80% had lymph node metastases at diagnosis, mainly in para-aorto-caval (48 %) and iliac areas (49%). In 1988, FIGO has included lymph node metastasis in stage IIIC, although some authors argue that only node involvement constitutes a clinical course different from IIIC cancer patients with abdominal diffusion.
Although it has been demonstrated that lymphadenectomy is technically feasible and relatively safe in this subset of patients, however, it is burdened by a certain percentage of complications including limphocyst, lymphedema, hemorrhage, ranging from 6% to 45%. In addition, the actual therapeutic role is still controversial and it is not clear whether this surgical procedure should be part of the staging of these tumors. Retrospective studies have shown a benefit on overall survival in patients with ovarian cancer who underwent lymphadenectomy associated with optimal debulking (residual tumor <1 cm). In a recent publication by SEER is found that the number of lymph nodes removed during surgery for advanced ovarian cancer is an independent prognostic factor.
In the literature there is only one prospective randomized study on lymphadenectomy in advanced ovarian cancer without node lesions macroscopically observed (bulky nodes) during the first surgery. The authors reported a significant benefit in terms of disease free survival (DFS), but not in terms of overall survival (OS) in patients who underwent systematic lymphadenectomy and who had a residual tumor <1 cm. Patients with intra-abdominal residual tumor <1 cm could theoretically not benefit from a systematic lymphadenectomy since most of lymph node metastases undetectable to intraoperative assessment are smaller than 1 cm.
About 20% of ovarian cancer patients stage III-IV, however, are not operable at the time of diagnosis because of the spread of the disease. In these cases, the gold standard treatment consists of submitting the patient to Interval Debulking Surgery (IDS) after neoadjuvant chemotherapy. The prognosis of these patients compared to those who are subjected to primary surgery, with the same residual tumor after surgery, is currently a topic of controversial debate. Recently, a multicenter, randomized EORTC showed no difference in prognosis between primary surgery and Interval Debulking Surgery in a population stratified by residual tumor. There are few retrospective studies that consider the presence of lymph node metastases in patients undergoing Interval Debulking Surgery: the percentage of lymph node metastases in this subset varies from 37.5% to 75%.
The purpose of the study is to assess whether systematic pelvic and aortic lymphadenectomy should be part of standard surgical procedures in patients with ovarian cancer who underwent surgery after neoadjuvant chemotherapy with intra-abdominal residual tumor <1 cm.
All patients candidate for Interval Debulking Surgery which do not present bulky nodes at surgery and which have an intra-abdominal residual tumor <1 cm at the end of the surgery will be enrolled in the study.
The baseline assessment of patients is to perform general blood tests, CA 125, CT thorax, abdomen, pelvis, anesthetic assessment and, if eligible, the patients will be subjected to the treatment above.
The enrollment period will last for 2 years until the achieving of 65 patients as the study population. The median follow-up of 6 months for all patients for the primary objectives and a median of 36 months for the secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systematic Lymphadenectomy | Experimental | Procedure: Systematic pelvic and aortic lymphadenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 75 years
- Patients affected by advanced ovarian cancer (FIGO stage III-IV) who underwent > 2 to <7 cycles of neoadjuvant chemotherapy based on platinum and taxanes.
- Clinical response (instrumental and serological) complete or partial.
- Residual intra-abdominal tumor <1 cm.
- Absence of disease macroscopically evident in lymph nodes (> 1 cm)
Key exclusion criteria (6 listed)
- Patients with severe impairment of lung function, or liver failure, such as not to allow access in safety in the operating room.
- Not epithelial ovarian neoplasms or borderline tumors
- Other invasive cancer in the last 5 years or signs of recurrence or activity
- Patients with intra-abdominal residual tumor> 1 cm
- Patients with the presence of bulky nodes (> 1 cm) in the intra-operative evaluation
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 |
|---|---|---|
| Systematic pelvic and aortic lymphadenectomyPelvic lymphadenectomy dissection began at the origin of the external iliac vessels and continued caudally along the medial border of the psoas muscle, with the lower limit of the external iliac lymphadenectomy being represented by the deep inferior epigastric vessels. The lateral boundaries of lymphadenectomy were delineated superficially by the fascia covering the psoas muscle and deeply by the fascia covering the internal obturator and levator ani muscles. Lymph nodes along the external iliac vessels were removed en bloc with those adjacent to the common iliac vessels. Aortic lymphadenectomy dissection began at the aortic bifurcation by removing the superficial intercavoaortic, precaval, and preaortic nodal groups. Lymph nodes located lateral to the vena (i.e., paracaval nodal group) were separated from the vena cava, then removed en bloc. Lymph nodes behind the vena cava are removed if enlarged. Removal of the lateroaortic nodes was performed up to the level of the left renal vein. | Procedure or surgery | Systematic Lymphadenectomy |
Primary outcome
Percentage of positive lymph nodes after neoadjuvant chemotherapy
Time frame: 6 months
Evaluation of complications related to the surgical procedure
Time frame: 6 months
2 secondary outcomes
Evaluation of disease-free interval (DFS)
Time frame: 36 months
Assessment of overall survival (OS)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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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.
Catholic University of Sacred Heart contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Systematic pelvic and aortic lymphadenectomy in people with Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 9 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 12 Nov 2012. 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 Italy. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Catholic University of Sacred Heart (+39 063 015 627 9), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of positive lymph nodes after neoadjuvant chemotherapy (time frame: 6 months). The study lists 2 primary outcomes in all. 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 12 Nov 2012.