Usefulness of FDG-PET for Advanced Cervical Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Chang Gung Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00146458
First received: September 6, 2005
Last updated: September 19, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Procedure: 18F-fluorodeoxyglucose positron emission tomography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • The difference of disease-free-survival and overall-survival with/ without FDG-PET at two years after treatment

Secondary Outcome Measures:
  • The incidence of additional extra-pelvic tumor metastasis detected by FDG-PET study, and its influence on the design of appropriate radiotherapy treatment

Estimated Enrollment: 200
Study Start Date: January 2002
Estimated Study Completion Date: December 2007
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 CT/MRI 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 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed cervical cancer clinical stage FIGO I –IVA
  • 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:

  • Cervical tumor with histologic diagnosis of verrucous carcinoma or small cell carcinoma
  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00146458

Locations
Taiwan
Department of Radiation Oncology, Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Chien-Sheng Tsai, M.D. Department of Radiation Oncology, Chang Gung Memorial Hospital
Study Director: Tin-Chang Chang, M.D., MPH. Director of Division of Gynecologic Oncology, Chang Gung Memorial Hospital, Linkou Medical Center
Study Chair: Chyong-Huey Lai, M.D. Chairman of Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00146458     History of Changes
Other Study ID Numbers: CTRP024, NSC 92-2314-B-182A-084
Study First Received: September 6, 2005
Last Updated: September 19, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Cervical cancer
FDG-PET
Lymph node metastasis
Radiotherapy
Chemotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014