Cervical CancerNCT01157962
Sentinel Concept in Early Stage Cervical Cancer
A study testing Lymphadenectomy in cervical cancer in people with Cervical Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative… 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?
- Lymphadenectomy in cervical cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky index
- Patients aged 18-70
- Histological assured cervix cancer (Squamous epithelium- or Adenoids cancer, adenosquamous cancer)
- Stadium FIGO from 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, till FIGO 1b1 L0 or L1 V0 ≤ 2cm
- Completed and signed consent form
- Cooperation qualities of patients
- Performed explanation patients and written consent
Who cannot join
- Tumour thickness > 2cm, FIGO- staging > 1b1
- Neuroendocrine tumoural or mixed types with neuroendocrine tissues
- Tumoural invasion in vascular system (V1)
- Pregnancy, during lactation women without reliable contraception during radiochemotherapy
- Existing malignant diseases (Exception: basalioma of the skin)
- Radiotherapy of pelvis in anamnesis
Show all 11Show fewer
- Severe internal associated diseases (Myocardial infarction, Heart pathology, Heart insufficiency NYHA III/IV, Severe chronic obstructive bronchopulmonary disease, kidney insufficiency, diabetes mellitus poorly regulated, uncontrolled infections) Anaesthesia not allowed
- Psychiatric diseases, which put off participating and after care
- HIV infection, or rather AIDS disease
- Drug addicted
- Precedent motorial or sensorial Polyneuropathies>CTC grade 1
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University of Berlin
Berlin, State of Berlin, 10117
Achim Schneider, Professor, +49 30 450 564 172, achim.schneider@charite.de
Achim Schneider, Professor
About this study
Official title: Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm
Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection.
For this purpose were randomized about 1200 patients with histological assured cervix carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy.
Primary end point is overall survival; this for both groups must be equal. Secondary end point is peri- and postoperative morbidity inclusive quality of life, the benefits for women must be evident with sentinel- lymph node dissection, don't have to show for both groups any significant difference.
Read the detailed description
After randomization and assignment to experimental or control group lymphadenectomy is carried out.
Four different techniques can be used: 1) laparoscopic transperitoneal 2) laparoscopic retroperitoneal 3) open extraperitoneal 4) open transperitoneal. Radioactive labeling of sentinel-lymph nodes with 99technetium-marked colloid and/or patent blue is carried out. On the day prior to the operation 50mBq 99technetium or on the day of operation 10 mBq 99technetium is injected subepithelially in the cervix at 12, 3, 6 and 9 o'clock. Preoperatively 4 cc patent blue are injected in the same manner subepithelially. At the beginning of surgery parametrial tumor involvement, intrabdominal tumor dissemination, invasion of vesica-cervical and recto-vaginal septum are excluded. A lavage of cul-de-sac for cytological analysis is performed. The retroperitoneum is opened lateral of iliac vessels and blue colored lymph or radioactive nodes are removed. Sentinel- lymph node's radioactive signal is documented in counts per second (cps).
If no sentinel-lymph node is detected, complete pelvic lymph node dissection is carried out. If tumor involved pelvic lymph nodes are shown, paraaortic lymph node dissection is carried out. If sentinel- or pelvic lymph nodes are quoted as tumor free at frozen sections, radical hysterectomy or radical trachelectomy is performed. Radical hysterectomy follows in an extension a type-2 variation. In patients with positive lymph nodes in frozen section or in definitive histo-pathology primary chemoradiation is performed.
- Conditions
- Cervical Cancer
- Being tested
- Lymphadenectomy in cervical cancer
- Keywords
- Sentinel Concept, Lymphadenectomy, Early Stage Cervical Cancer, Overall Survive, Improvement Therapy
- 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.
Lymphadenectomy in cervical cancerProcedure or surgery
Also called Sentinel node dissection and radical pelvic dissection
Sentinel lymphadenectomy vs systematic pelvic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Group A Sentinel lymphadenectomy | Experimental | In group A exclusively sentinel lymphadenectomy is performed Receives: Procedure: Lymphadenectomy in cervical cancer |
| Group B radical pelvine lymphadenectomy | Active comparator | in group B radical systematic pelvic lymphadenectomy is done. In patients with tumor free lymph nodes either radical hysterectomy or, in women seeking parenthood, radical trachelectomy is performed. If lymph nodes are tumor-involved systematic pelvic and paraaortic lymphadenectomy followed by primary chemoradiation is recommended. Receives: Procedure: Lymphadenectomy in cervical cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Primary study end point is that overall survival of patients with sentinel-concept, has not to differentiate from that one of patients with systematic lymph node dissection.
Measured: one year
Secondary outcomes (1)
morbidity
Secondary study end points are peri- und postoperative complications percentage and life quality after EORTC QLQ C-30 and local control. Local control percentage must exhibit no difference for both groups. Complications percentage and life quality must be significative better in branch with sentinel-lymph node dissection.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2014 (estimated)
- Study completionJan 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.
- More trials run by Charite University, Berlin, GermanyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157962
- Sponsor's protocol ID
- EA1/207/09
- Status last verified
- Dec 2009
- First submitted
- 22 Jun 2010
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Altgassen C, Hertel H, Brandstadt A, Kohler C, Durst M, Schneider A; AGO Study Group. Multicenter validation study of the sentinel lymph node concept in cervical cancer: AGO Study Group. J Clin Oncol. 2008 Jun 20;26(18):2943-51. doi: 10.1200/JCO.2007.13.8933.
PubMed 18565880
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm
- ClinicalTrials.gov ID
- NCT01157962
- Acronym / sponsor ID
- EA1/207/09
- Conditions
- Cervical Cancer
- Keywords
- Sentinel Concept, Lymphadenectomy, Early Stage Cervical Cancer, Overall Survive, Improvement Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 8 Jul 2010 (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.
Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection.
For this purpose were randomized about 1200 patients with histological assured cervix carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy.
Primary end point is overall survival; this for both groups must be equal. Secondary end point is peri- and postoperative morbidity inclusive quality of life, the benefits for women must be evident with sentinel- lymph node dissection, don't have to show for both groups any significant difference.
Detailed description
After randomization and assignment to experimental or control group lymphadenectomy is carried out.
Four different techniques can be used: 1) laparoscopic transperitoneal 2) laparoscopic retroperitoneal 3) open extraperitoneal 4) open transperitoneal. Radioactive labeling of sentinel-lymph nodes with 99technetium-marked colloid and/or patent blue is carried out. On the day prior to the operation 50mBq 99technetium or on the day of operation 10 mBq 99technetium is injected subepithelially in the cervix at 12, 3, 6 and 9 o'clock. Preoperatively 4 cc patent blue are injected in the same manner subepithelially. At the beginning of surgery parametrial tumor involvement, intrabdominal tumor dissemination, invasion of vesica-cervical and recto-vaginal septum are excluded. A lavage of cul-de-sac for cytological analysis is performed. The retroperitoneum is opened lateral of iliac vessels and blue colored lymph or radioactive nodes are removed. Sentinel- lymph node's radioactive signal is documented in counts per second (cps).
If no sentinel-lymph node is detected, complete pelvic lymph node dissection is carried out. If tumor involved pelvic lymph nodes are shown, paraaortic lymph node dissection is carried out. If sentinel- or pelvic lymph nodes are quoted as tumor free at frozen sections, radical hysterectomy or radical trachelectomy is performed. Radical hysterectomy follows in an extension a type-2 variation. In patients with positive lymph nodes in frozen section or in definitive histo-pathology primary chemoradiation is performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Sentinel lymphadenectomy | Experimental | Procedure: Lymphadenectomy in cervical cancerIn group A exclusively sentinel lymphadenectomy is performed |
| Group B radical pelvine lymphadenectomy | Active comparator | Procedure: Lymphadenectomy in cervical cancerin group B radical systematic pelvic lymphadenectomy is done. In patients with tumor free lymph nodes either radical hysterectomy or, in women seeking parenthood, radical trachelectomy is performed. If lymph nodes are tumor-involved systematic pelvic and paraaortic lymphadenectomy followed by primary chemoradiation is recommended. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Karnofsky index
- Patients aged 18-70
- Histological assured cervix cancer (Squamous epithelium- or Adenoids cancer, adenosquamous cancer)
- Stadium FIGO from 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, till FIGO 1b1 L0 or L1 V0 ≤ 2cm
- Completed and signed consent form
Key exclusion criteria (11 listed)
- Tumour thickness > 2cm, FIGO- staging > 1b1
- Neuroendocrine tumoural or mixed types with neuroendocrine tissues
- Tumoural invasion in vascular system (V1)
- Pregnancy, during lactation women without reliable contraception during radiochemotherapy
- Existing malignant diseases (Exception: basalioma of the skin)
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 |
|---|---|---|
| Lymphadenectomy in cervical cancerAlso: Sentinel node dissection and radical pelvic dissectionSentinel lymphadenectomy vs systematic pelvic lymphadenectomy | Procedure or surgery | Group A Sentinel lymphadenectomy, Group B radical pelvine lymphadenectomy |
Primary outcome
overall survival
Time frame: one year
Primary study end point is that overall survival of patients with sentinel-concept, has not to differentiate from that one of patients with systematic lymph node dissection.
1 secondary outcome
morbidity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Results publication: PubMed 18565880Altgassen C, Hertel H, Brandstadt A, Kohler C, Durst M, Schneider A; AGO Study Group. Multicenter validation study of the sentinel lymph node concept in cervical cancer: AGO Study Group. J Clin Oncol. 2008 Jun 20;26(18):2943-51. doi: 10.1200/JCO.2007.13.8933.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphadenectomy in cervical cancer in people with Cervical Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
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 7 inclusion and 11 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 1 Jul 2011. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: one year). 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 NCT01157962, 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 1 Jul 2011.