Diagnostic value of (18)F-FDG PET for evaluation of paraaortic nodal metastasis in patients with cervical carcinoma: a metaanalysis.
Sokbom Kang, Seok-Ki Kim, Dae-Chul Chung...
https://pubmed.ncbi.nlm.nih.gov/20150275/Actively Recruiting
Led by Chongqing University Cancer Hospital · Updated on 2023-08-31
1956
Participants Needed
1
Research Sites
296 weeks
Total Duration
Researchers are evaluating whether surgery staging is better than image staging for women with locally advanced cervical cancer. This prospective, non-randomized controlled trial aims to compare the effects of these two staging methods on progression-free survival and overall survival. The study focuses on patients with specific cervical cancer stages and types, seeking to improve treatment outcomes by assessing different approaches to staging before chemoradiation therapy. Participants are assigned to one of two groups without randomization. One group receives standard image staging followed by concurrent chemoradiation, which includes pelvic or extended-field external beam radiation therapy EBRT, platinum-based chemotherapy, and brachytherapy. The other group undergoes surgery staging via open or minimally invasive para-aortic lymph node dissection up to at least the inferior mesenteric artery, followed by chemoradiation within 28 days. Chemoradiation protocols are consistent across groups, but extended-field EBRT is tailored based on pathological findings in the surgery group. During the study, participants will be closely monitored for disease progression and survival over three and five years. Researchers will assess progression-free survival at three years as the primary outcome and overall survival and complications at one and five years as secondary outcomes. The study involves regular imaging, biopsies, and clinical assessments to track responses and side effects. Participation lasts throughout treatment and includes follow-up visits to ensure safety and evaluate long-term results.
CONDITIONS
Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer
D
Dongling Zou, M.D.
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Chongqing University Cancer Hospital
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days post-surgery
Participants in the surgery staging group undergo open or minimally invasive para-aortic lymph node dissection. Chemoradiation starts within 28 days after surgery.
1 surgical procedure and follow-up visits as needed post-operation
Duration - Concurrent chemoradiation completed within 56 days; adjuvant chemotherapy cycles if applicable
Participants receive standard concurrent chemoradiation, including pelvic or extended-field external beam radiation therapy, brachytherapy, and weekly platinum-containing chemotherapy cycles. For some, additional adjuvant chemotherapy may be given depending on residual disease.
Weekly visits for up to 8 weeks including radiation and chemotherapy sessions
Duration - Up to 5 years
Participants are monitored for progression-free survival, overall survival, and complications up to 5 years after treatment.
Periodic follow-up visits for assessments over several years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor