- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01218490
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer (CARACO)
May 14, 2019 updated by: Institut Cancerologie de l'Ouest
Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Amiens, France, 80000
- Clinique Sainte Thérèse
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Angers, France, 49000
- Centre Paul Papin
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Angers, France, 49000
- Hospital
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Brest, France, 29609
- Hospital
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Dijon, France, 21079
- Centre G F Leclerc
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Lyon, France, 69437
- Hospital
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Marseille, France, 13009
- Institut Paoli Calmette
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Montpellier, France, 34298
- Centre Val D'Aurelle
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Paris, France, 75010
- Hôpital Lariboisière
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Paris, France, 75000
- Hôpital Européen Georges Pompidou
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Paris, France, 75020
- Hôpital des Diaconesses
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Rennes, France, 35000
- Clinique Mutualiste
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Rennes, France, 35000
- Hopital
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Saint Cloud, France, 92210
- Centre René Huguenin
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Saint Herblain, France, 44805
- Institut Cancerologie de l'Ouest
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Strasbourg, France, 67065
- Centre Paul Strauss
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Toulouse, France, 31052
- Institut Claudius Regaud
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Tours, France, 37044
- Hôpital Bretonneau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age> 18 years
- Karnofsky> 80, or ASA I-II
- Primary ovarian adenocarcinoma, or primitive peritoneal
- No retroperitoneal lymph node> 2cm (CT; MRI)
- Complete surgical staging
- Stage III-IV FIGO classification
- Indication of systemic chemotherapy before surgery or post surgery
Exclusion Criteria:
- Non Invasive Cancer
- non-epithelial or borderline cancer
- Pregnancy
- Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer
- Contraindication to Platinum and Paclitaxel
- Borderline Ovarian Tumor
- tumor recurrence
- Incomplete surgery, resectable lesion, Surgery sub optimal (R> 1cm)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lymphadenectomy
after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy
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No Intervention: no lymphadectomy
after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival with out recurrence
Time Frame: 5 years
|
5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2008
Primary Completion (Anticipated)
May 1, 2026
Study Completion (Anticipated)
May 1, 2026
Study Registration Dates
First Submitted
October 8, 2010
First Submitted That Met QC Criteria
October 8, 2010
First Posted (Estimate)
October 11, 2010
Study Record Updates
Last Update Posted (Actual)
May 16, 2019
Last Update Submitted That Met QC Criteria
May 14, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- SC 07/12-H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
Clinical Trials on ovarian cancer surgery
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Azienda Ospedaliera di PadovaUniversity of PadovaRecruiting
-
Min WangFirst Hospital of China Medical UniversityUnknown
-
University of UdineRecruitingOvarian Cancer Stage IV | Ovarian Cancer Stage IIIItaly
-
Lei LiUnknownOvarian High Grade Serous Carcinoma | Immune Repertoire | T Lymphocyte Receptor | B Lymphocyte ReceptorChina
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
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Taipei Veterans General Hospital, TaiwanUnknown
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Stiftung Swiss Tumor InstituteKlinik Hirslanden, Zurich; Manja Gideon FoundationTerminatedOvarian Neoplasms | Patient Reported Outcome MeasuresSwitzerland
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Saad AmerUniversity Hospitals of Derby and Burton NHS Foundation TrustUnknown
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AGO Study GroupCancer Research UK; ARCAGY/ GINECO GROUP; Grupo Español de Investigación en Cáncer... and other collaboratorsCompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cavity CancerSpain, France, Denmark, Belgium, Germany, Austria, China, Italy, Korea, Republic of, Norway, Sweden, United Kingdom
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Azienda Ospedaliera San Giovanni BattistaHumanitas Hospital, ItalyUnknown