Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146458
Status:
UNKNOWN
Last Update Posted:
2006-09-20
First Post:
2005-09-06
Brief Title:
Usefulness of FDG-PET for Advanced Cervical Cancer
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
A Phase III Randomized Trial of FDG-PET in the Management of Advanced Cervical Cancer With Enlarged Pelvic Lymph Node on MRI Image
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determinate whether the adding of FDG-PET is helpful in the treatment of advanced cervical cancer with concurrent chemoradiation
Detailed Description:
Concurrent radiotherapy and chemotherapy is the standard treatment for locally advanced cervical cancer The radiation field should be adjusted according to the extension of disease especially the presence of metastatic lymph nodes At present CT MRI have been applied for the detection of enlarged lymph nodes as the reference of radiation field However not infrequently a small-sized lymph node on CTMRI may be metastatic while an enlarged node may be resulted from reactive hyperplasia
Unlike CT MRI 18F-FDG positron emission tomography FDG-PET provides a novel means of imaging malignancy and could differentiate benign tumor from malignancy by functional assessment Recent studies demonstrated higher accuracy of FDG-PET scan for the evaluation of metastasis in patients with several types of cancers when compared with CT scan or MRI But only a few reports concerned the usefulness of FDG-PET in cervical carcinoma
Our hypothesis is that adding FGD-PET study to a thorough MRI can provide better staging especially on the identification of metastatic pelvic or para-aortic lymph nodes In addition this whole body scan may also detect occult distant metastases that are not detectable by standard workup Our initial result of a phase II study---A Preliminary Report of Using FDG-PET to Detect Extra-pelvic Lesions in Cervical Cancer Patients with Enlarged Pelvic Lymph Nodes Shown on MRICT Images indicated that FDG-PET helped to detect occult or small metastatic lesions and resulted in a change of radiation treatment plan Nevertheless for high-risk group patients distant metastasis still occurred in a short period after treatment Therefore it is also our question that whether the enhancement of detection provided by FDG-PET can be translated into improvement of final overall survival
To answer these questions the Gynecologic Oncology Study Group in Chang Gung Memorial Hospital has designed a phase III clinical study Patients with enlarged pelvic lymph node detected on MRI imaging are enrolled and randomized into two groups before the initiation of concurrent chemoradiation
Unlike CT MRI 18F-FDG positron emission tomography FDG-PET provides a novel means of imaging malignancy and could differentiate benign tumor from malignancy by functional assessment Recent studies demonstrated higher accuracy of FDG-PET scan for the evaluation of metastasis in patients with several types of cancers when compared with CT scan or MRI But only a few reports concerned the usefulness of FDG-PET in cervical carcinoma
Our hypothesis is that adding FGD-PET study to a thorough MRI can provide better staging especially on the identification of metastatic pelvic or para-aortic lymph nodes In addition this whole body scan may also detect occult distant metastases that are not detectable by standard workup Our initial result of a phase II study---A Preliminary Report of Using FDG-PET to Detect Extra-pelvic Lesions in Cervical Cancer Patients with Enlarged Pelvic Lymph Nodes Shown on MRICT Images indicated that FDG-PET helped to detect occult or small metastatic lesions and resulted in a change of radiation treatment plan Nevertheless for high-risk group patients distant metastasis still occurred in a short period after treatment Therefore it is also our question that whether the enhancement of detection provided by FDG-PET can be translated into improvement of final overall survival
To answer these questions the Gynecologic Oncology Study Group in Chang Gung Memorial Hospital has designed a phase III clinical study Patients with enlarged pelvic lymph node detected on MRI imaging are enrolled and randomized into two groups before the initiation of concurrent chemoradiation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NSC 92-2314-B-182A-084 | None | None | None |