UMIN-CTR Clinical Trial

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

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

Obstetrics and Gynecology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Cancer Institute

Institute

Department

Personal name

Organization

National Cancer Institute

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2011

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

11

Month

29

Day

Last modified on

2024

Year

02

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008035