Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2002-01-31
2007-12-31
Brief Summary
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Detailed Description
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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 MRI/CT 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Interventions
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18F-fluorodeoxyglucose positron emission tomography
Eligibility Criteria
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Inclusion Criteria
* Histologically proven cervical carcinoma (including histologic types of squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, adenoid cystic carcinoma, lymphoepithelial-like carcinoma and malignant mixed mullerian tumor)
* Presence of at least one enlarged pelvic lymph node (\>=1.0 cm in its maximal dimension), or group of small pelvic nodes (size \<1 cm), and without suspicious para-aortic lymph node metastasis or any lesion outside the pelvis by conventional MRI or CT study
* Karnofsky performance scale \>=60
* Available for concurrent chemoradiation therapy of curative intent
Exclusion Criteria
* Other serious illness or medical condition which would interfere with extended field irradiation or chemotherapy
* Past or current history of malignancy, except for curatively treated non-melanoma skin cancer
* Patients not suitable to receive PET study either by technical or psychological reasons
* Patients who are judged to be noncompliant to treatment or not accessible for follow up
0 Years
FEMALE
No
Sponsors
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National Science and Technology Council, Taiwan
OTHER_GOV
Chang Gung Memorial Hospital
OTHER
Principal Investigators
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Chien-Sheng Tsai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Chang Gung Memorial Hospital
Tin-Chang Chang, M.D., MPH.
Role: STUDY_DIRECTOR
Director of Division of Gynecologic Oncology, Chang Gung Memorial Hospital, Linkou Medical Center
Chyong-Huey Lai, M.D.
Role: STUDY_CHAIR
Chairman of Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical Center
Locations
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Department of Radiation Oncology, Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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References
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Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.
Other Identifiers
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NSC 92-2314-B-182A-084
Identifier Type: -
Identifier Source: secondary_id
CTRP024
Identifier Type: -
Identifier Source: org_study_id