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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006787
Receipt No. R000008035
Scientific Title UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING PRIOR TO PRIMARY CHEMORADIATIONTHERAPY TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA >=;4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMA; SEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE); AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE)
Date of disclosure of the study information 2011/12/01
Last modified on 2019/03/13

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Basic information
Public title UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING PRIOR TO PRIMARY CHEMORADIATIONTHERAPY TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA >=;4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMA; SEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE); AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE)
Acronym UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX AND HIGH RISK ENDOMETRIAL CANCER
Scientific Title UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING PRIOR TO PRIMARY CHEMORADIATIONTHERAPY TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA >=;4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMA; SEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE); AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE)
Scientific Title:Acronym UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX AND HIGH RISK ENDOMETRIAL CANCER
Region
Japan Asia(except Japan) North America

Condition
Condition PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA >=;4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMA; SEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE); AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE)
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1)To evaluate the diagnostic sensitivity and specificity of preoperative FDGPET/ CT imaging in identifying metastases to abdominal (common iliac, paraaortic, and para-caval) lymph nodes in participants with locoregionally advanced cervical carcinoma.
2)To evaluate the diagnostic sensitivity and specificity of preoperative FDGPET/ CT imaging in identifying metastases to retroperitoneal abdominal lymph nodes in participants with high-risk endometrial cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1.
Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) GOG PS: 0, 1, or 2.
2) Participants should have creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2; there is no lower limit of normal for serum creatinine for this protocol.
3) Participants of child-bearing potential must have a negative urine or serum pregnancy test result within 7 days prior to undergoing PET/CT. In addition, they would undergo a urine test on the day of PET/CT examination. The urine test at the institution should detect hCG at the sensitivity of 25 mIU/mL. If the urine test does not have the required sensitivity, a negative serum test is required. Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not to be of child-bearing potential.
4) Participants must sign an IRB-approved informed consent and authorization permitting release of personal health information.
5) Participants must be enrolled at an ACRIN-affiliated institution that is accredited by GOG.

Cervical Cancer Only:
1) Participants must have primary, previously untreated, histologically confirmed, locoregionally advanced (IB2, IIA >=4cm, IIB-IVA), invasive carcinoma of the cervix (any cell type) and be considered for chemoradiation therapy.
2) Participants must be appropriate surgical candidates to undergo extra-peritoneal or laparoscopic lymph node sampling.

Endometrial Cancer Only:
1) Participants must have histologically confirmed Grade 3 endometrioid or nonendometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma as diagnosed from an endometrial biopsy or dilation and curettage or histologically confirmed Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage.
2) Participants must be appropriate surgical candidates to undergo hysterectomy and lymph node sampling.
Key exclusion criteria 1) Patients who had a prior pelvic or abdominal lymphadenectomy performed for any reason.
2) Patients who have received prior pelvic radiation therapy for any reason.
3) Patients with circumstances that will not permit completion of the imaging studies or required follow up.
4) Patients with renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, which would require modification of the lymphadenectomy.
5) Patients with a history of anaphylactic or life-threatening allergic reactions to any contrast media.
6) Patients who are pregnant or lactating or who suspect they might be pregnant.
7) GOG PS: 3 or 4
8) Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
9) Patients with a history of cirrhosis.
10) Patients with poorly controlled, insulin-dependent diabetes (fasting blood glucose level >200 mg/dL).
11) Patients weighing greater than that allowable by the PET/CT scanner.

Cervical Cancer Only:
1) Patients with recurrent invasive carcinoma of the uterine cervix regardless of previous treatment.
2) Patients who have known metastases to lungs, scalene lymph nodes, or metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis.
3) Patients with any stage of cervical cancer other than IB2, IIA >=4cm, and IIB-IVA.

Endometrial Cancer Only:
1) Patients with recurrent invasive carcinoma of the uterus regardless of previous treatment.
Target sample size 380

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mostafa Atri, MD, Dip, Epid
Organization Toronto General Hospital
Division name Department of Medical Imaging
Zip code
Address 585 University Avenue Toronto, ON Canada M5G 2N2
TEL +1-416-340-4880
Email support@gogstats.org

Public contact
Name of contact person
1st name
Middle name
Last name Shoji Nagao, MD,PhD
Organization Hyogo Cancer Center
Division name Department of Gynecology
Zip code
Address 13-70, Kitaoji-cho, Akashi, Hyogo
TEL 078-929-1151
Homepage URL http://www.gog.org
Email nrg-japan@newkast.or.jp

Sponsor
Institute National Cancer Institute
Institute
Department

Funding Source
Organization National Cancer Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00416455
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 10 Month 23 Day
Date of IRB
2013 Year 06 Month 06 Day
Anticipated trial start date
2013 Year 06 Month 06 Day
Last follow-up date
2016 Year 10 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 29 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008035

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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