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Cervical Canceruterus11NCT01049100

Surgical Staging in Cervical Cancer Prior to Chemoradiation

A study testing lymphadenectomy and Standard Staging in people with Cervical Cancer, run by Charite University, Berlin, Germany at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival. 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 and Standard Staging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
2 sitesGermany
Study dates
Apr 2009to Apr 2017
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 =/> 70,
  • age between 18 - 70 years
  • histological assured cervical cancer (by biopsy)
  • FIGO stages II B - IV
  • written informed consent
  • patient's ability to cooperate

Who cannot join

  • neuroendocrine tumors or histological mixed types containing neuroendocrine fractions
  • pregnancy, lactation,
  • distant metastases, except paraaortal metastases
  • other malignant diseases in anamnesis
  • pelvic radiotherapy in anamnesis
  • severe internal diseases
Show all 10Show fewer
  • psychiatric diseases which might query the trial attendance or follow-up
  • HIV-Infection or AIDS
  • drug addiction
  • existing motoric or sensoric polyneuropathy > CTC Grad 1

Trial locations and contacts

2 sites in 1 country.

Simone Marnitz, PD contact

004930450627162

simone.marnitz@charite.de

Germany2 sites, 2 recruiting

  • Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin

    Berlin, 10117

    Christhardt Köhler, Professor, 004930450564091, christhardt.koehler@charite.de

    Anja Dittgen, 004930450664434, anja.dittgen@charite.de

    Recruiting

  • Department of Radiooncology, Charité Campus Mitte und Campus Virchow

    Berlin, 10117

    Simone Marnitz, PD, 004930450527162, simone.marnitz@charite.de

    Anja Dittgen, 004930450664434, anja.dittgen@charite.de

    Recruiting

Other trials in Germany

About this study

Official title: Prospective, Randomised and Multi-centric Therapy Optimisation Study for Examining the Influence of Surgical Staging on the Oncological Results for Patients With Cervix Carcinoma of the FIGO Stages IIB-IV After Chemoradiation

The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

Read the detailed description

The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

To this end, 250 patients with histologically verified cancer of the cervix uteri of the stages IIB-IV shall be randomised to a standard arm (ARM B), whereby the therapy shall be conducted on the basis of the clinical FIGO stage.

The patients randomised to the test arm (Arm A), after determining the clinical FIGO stage, shall initially receive an operative staging in the form of a pelvine paraaortal lymphadenectomy (laparoscopic or open). On the basis of the operatively obtained findings, a ("surgically") modified tumour stage shall be determined. This "surgical" tumour stage, which shall take into account the affection of the lymph nodes, the infiltration of the neighbouring organs and the intraperitoneal spread, shall serve as the basis for the execution of primary, combined radio-chemotherapy. The primary end-point is the disease-free survival of both groups, the secondary endpoints are overall survival, the local control of both groups, as well as the determination of toxicity and the quality of life.

Conditions
Cervical Cancer
Being tested
lymphadenectomy, Standard Staging
Keywords
Surgical Staging, Cervical Cancer, Chemoradiation, Outcome, Toxicity
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.

  • lymphadenectomyProcedure or surgery

    Also called debulking, surgical staging

    paraaortal and pelvic lymphadenectomy laparoscopic or open

  • Standard StagingOther

    Also called FIGO Staging

    clinical Staging (FIGO) (examination in narcosis, biopsy, cystoscopy, rectoscopy) X-Ray Radiograph of Thorax, Ultrasound of abdomen, CT abdomen / pelvis positive, suspicious lymphnodes--> CT controlled biopsy

Study groups in NCT01049100
Study groupRoleWhat they receive
operative staging (A)Experimentaloperative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open
Receives: Procedure: lymphadenectomy
Standard (B)No interventionNo surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--> CT controlled biopsy and histological analysis.
Receives: Other: Standard Staging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DFS (disease-free survival)

    Measured: 4 years

Secondary outcomes (1)

  1. OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionApr 2013 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

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
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01049100
Sponsor's protocol ID
108771
Acronym
uterus11
Status last verified
Aug 2009
First submitted
13 Jan 2010
Last updated
15 Jan 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Sakuragi N. Up-to-date management of lymph node metastasis and the role of tailored lymphadenectomy in cervical cancer. Int J Clin Oncol. 2007 Jun;12(3):165-75. doi: 10.1007/s10147-007-0661-2. Epub 2007 Jun 27.

    PubMed 17566838

  • Subak LL, Hricak H, Powell CB, Azizi L, Stern JL. Cervical carcinoma: computed tomography and magnetic resonance imaging for preoperative staging. Obstet Gynecol. 1995 Jul;86(1):43-50. doi: 10.1016/0029-7844(95)00109-5.

    PubMed 7784021

  • Marnitz S, Kohler C, Roth C, Fuller J, Bischoff A, Wendt T, Schneider A, Budach V. Stage-adjusted chemoradiation in cervical cancer after transperitoneal laparoscopic staging. Strahlenther Onkol. 2007 Sep;183(9):473-8. doi: 10.1007/s00066-007-1675-4.

    PubMed 17762920

  • Bye A, Trope C, Loge JH, Hjermstad M, Kaasa S. Health-related quality of life and occurrence of intestinal side effects after pelvic radiotherapy--evaluation of long-term effects of diagnosis and treatment. Acta Oncol. 2000;39(2):173-80. doi: 10.1080/028418600430734.

    PubMed 10859007

  • Nag S, Erickson B, Thomadsen B, Orton C, Demanes JD, Petereit D. The American Brachytherapy Society recommendations for high-dose-rate brachytherapy for carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):201-11. doi: 10.1016/s0360-3016(00)00497-1.

    PubMed 10924990

  • Lai CH, Huang KG, Hong JH, Lee CL, Chou HH, Chang TC, Hsueh S, Huang HJ, Ng KK, Tsai CS. Randomized trial of surgical staging (extraperitoneal or laparoscopic) versus clinical staging in locally advanced cervical cancer. Gynecol Oncol. 2003 Apr;89(1):160-7. doi: 10.1016/s0090-8258(03)00064-7.

    PubMed 12694671

  • Denschlag D, Gabriel B, Mueller-Lantzsch C, Tempfer C, Henne K, Gitsch G, Hasenburg A. Evaluation of patients after extraperitoneal lymph node dissection for cervical cancer. Gynecol Oncol. 2005 Mar;96(3):658-64. doi: 10.1016/j.ygyno.2004.08.053.

    PubMed 15721408

Questions about this trial

What is this clinical trial studying?

A study testing lymphadenectomy and Standard Staging in people with Cervical Cancer, run by Charite University, Berlin, Germany at 2 sites 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 6 inclusion and 10 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 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact Simone Marnitz, PD (004930450627162, simone.marnitz@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (disease-free survival) (time frame: 4 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 NCT01049100, which also lists 7 linked publications.

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 Jan 2010.

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