Ovarian Cancer Clinical Trial
Official title:
Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Ovarian Cancer and Peritoneal Metastasis
Verified date | April 2015 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the
diagnosis is often been made in an advanced cancer stage with metastases throughout the
peritoneum.
An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for
the first time that patients in such an advanced stage of ovarian cancer who received first
three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking
surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had
fewer complications than patients treated with primary debulking surgery followed by
chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The
most important prognostic marker appeared to be whether patients with primary or interval
surgery no longer had a visible residual tumor after the treatment. Patients who had only
small metastases in the peritoneum, seemed to be better treated with primary surgery
(neoadjuvant Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian
Crystallising, N Engl J Med 363 (1910): 943 - 953).
Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation
where they assess which of the two treatments is the best option.
The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a
non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal
metastases. This is to assess which of the two treatments (primary debulking surgery
followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval
debulking surgery, followed in turn by chemotherapy) is the best option for a particular
type of patient.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with stage IIIC or IV epithelial ovarian cancer in the presence of peritoneal metastasis are, on a voluntary basis, enrolled in the study. These are patients who 'll either underwent primary debulking surgery followed by at least six courses of platinum-based chemotherapy or patients who will be assigned to three courses of neoadjuvant platinum-based chemotherapy followed by interval debulking surgery, followed in turn by at least three courses of platinum-based chemotherapy. Exclusion Criteria: - Patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients) will be excluded from this study. And so are patients with contra-indications to Gadolinium-based contrast agents and patients with a known restricted renal function (GFR < 30 ml/min). |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Gasthuisberg | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of WB-DWI as a noninvasive method to assess which kind of treatment fits best for a particular patient with ovarian cancer in the presence of peritoneal metastasis | The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI)as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to evaluate which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient. | 2011-2015 continuously | No |
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