Clinical trial · Interventional
Usefulness of FDG-PET for Advanced Cervical Cancer
A Phase III Randomized Trial of FDG-PET in the Management of Advanced Cervical Cancer With Enlarged Pelvic Lymph Node on MRI Image
NCT00146458CI-TRIAL-00000454unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-fluorodeoxyglucose positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The difference of disease-free-survival and overall-survival with/ without FDG-PET at two years after treatment
Secondary outcomes (1)
- measure
- The incidence of additional extra-pelvic tumor metastasis detected by FDG-PET study, and its influence on the design of appropriate radiotherapy treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 0 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTTsai 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. PMID 15050330