Health Condition 1: C56- Malignant neoplasm of ovary
Conditions
Interventions
Intervention1: CCRT after surgical debulking of bulky LNs or multiple LNs: within 2 weeks after enrollment to end of treatment- CCRT is to be performed after bulky or multiple LN debulking. CCRT cons
Sponsors
Korean Gynecologic Oncology Group
Eligibility
Inclusion criteria
Inclusion criteria: (1) Women =20 years and = 70 years of age 1) Newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 2) When the radiology examinations such as CT, MRI, or PET-CT show the short-axis of the pelvic LN or paraaortic LN under the renal vein is = 2cm, or 3 or more LNs with a short axis = 1 cm 3) When CCRT is planned as a treatment for cervical cancer 4) A patient whose competency is ECOG performance score 0-1 5) A patient which has signed the approved informed consent form for study subjects 6) A patient for which it is determined that surgical debulking is possible for LN metastasis as confirmed by radiological examination
Exclusion criteria
Exclusion criteria: (1) A patient who has been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) A patient that is pregnant or plans to become pregnant during the clinical study period (3) A patient with any active infectious disease or incurable severe inflammation. (4) When surgery is not possible due to internal or surgical disease (5) When chemotherapy is impossible due to internal or surgical disease (6) A patient with a history of pelvic radiation therapy (7) A patient with a history of subtotal hysterectomy (7)A patient with a remote metastasis (e.g., lung, supraclavicular lymph node,inguinal lymph node, etc.) other than a pelvic lymph node or paraaortic lymph node metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to check the progression-free survival rateTimepoint: Starting from baseline,(after patient registration) for up to 3 years after the patient is registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare treatment-related complicationsTimepoint: 1-4 years;- To evaluate the diagnostic accuracy of imaging examination for the diagnosis of bulky LNs or multiple LNsTimepoint: 1-4 years | — |
Countries
India
Contacts
Public ContactDona Chakraborty
KolGOTrg
Outcome results
None listed