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LOROCSON study: Late Onset Recurrent Ovarian Cancer: Surgery Or Not.


- candidate number0
- NTR NumberNTR344
- ISRCTNISRCTN50678517
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR13-okt-2005
- Secondary IDsMEC 2005-128 
- Public TitleLOROCSON study: Late Onset Recurrent Ovarian Cancer: Surgery Or Not.
- Scientific TitleA randomized phase III study for the treatment of recurrent epithelial ovarian cancer: chemotherapy alone versus chemotherapy followed by secondary cytoreductive surgery in patients with a disease-free interval of more than 6 months.
- ACRONYMLOROCSON
- hypothesisThe median progression-free survival in the chemotherapy- alone arm is assumed to be 13 months. It is assumed that the addition of surgery increases the median progression-free survival with four months.
- Healt Condition(s) or Problem(s) studiedOvarian cancer
- Inclusion criteriaRecurrence of epithelial ovarian cancer, after first line chemotherapy with a disease-free interval of at least 6 months, age> 18 years, WHO Performance status 0-2. The first-line therapy should have consisted of at least 4 courses of either cisplatin or carboplatin.
- Exclusion criteriaMore than one line chemotherapy, complete bowel obstruction, metastasized carcinoma (other tumor), leptomeningeal or brain metastases.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate1-okt-2010
- Target number of participants700
- InterventionsAfter registration the patient will immediately start the first course of chemotherapy. After the induction chemotherapy the response to therapy will be evaluated. In case of progressive disease the patient will go off treatment. The other patients will be randomized to either continuation of the chemotherapy without surgery (treatment A) versus secondary cytoreductive surgery followed by chemotherapy (treatment B).
- Primary outcomeProgression-free survival.
- Secondary outcomeSurvival, toxicity, surgical treatment related complications and quality of life.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P.M.L.H. Vencken
- CONTACT for SCIENTIFIC QUERIES A. Logmans
- Sponsor/Initiator Erasmus Medical Center, Department of Obstetrics and Gynecology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryA randomized phase III study for the treatment of recurrent epithelial ovarian cancer: chemotherapy alone versus chemotherapy followed by secondary cytoreductive surgery in patients with a disease-free interval of more than 6 months: LOROCSON Late Onset Recurrent Ovarian Cancer: Surgery Or Not Objectives: The general purpose of the study is to evaluate the benefits and risks of secondary cytoreductive surgery in patients with late onset recurrent epithelial ovarian cancer. The study will be prospective, multi-center, Study endpoints are primary: progression-free survival and secondary: survival, toxicity, surgical treatment related complications and quality of life. Patient selection criteria: * Inclusion: recurrence of epithelial ovarian cancer, after first line chemotherapy with a disease-free interval of at least 6 months, age> 18 years, WHO Performance status 0-2. The first-line therapy should have consisted of at least 4 courses of either cisplatin or carboplatin. * Exclusion: more than one line chemotherapy, complete bowel obstruction, metastasized carcinoma (other tumor), leptomeningeal or brain metastases. Randomization: * Stage at initial diagnosis (early I-IIa vs. advanced stage IIb-IV). * Length of disease free interval between the time of curation and registration to this protocol (between 6 months and 2 years versus more than 2 years). * Response to 2nd line induction chemotherapy, i.e. first three cycles of this trial (no change versus partial remission versus complete remission). * Number of measurable tumor lesions at registration (1 versus more than 1). * Largest tumor size of recurrence at registration (< 5 cm vs. > 5cm). * Institution. * Peritonitis or ascites present at initial surgery. * Tumor-diameter after initial surgery (no, 0-1 cm, >1 cm). Trial design: After registration the patient will immediately start the first course of chemotherapy. After the induction chemotherapy the response to therapy will be evaluated. In case of progressive disease the patient will go off treatment. The other patients will be randomized to either continuation of the chemotherapy without surgery (treatment A) versus secondary cytoreductive surgery followed by chemotherapy (treatment B). Clinical evaluation, laboratory tests and follow up: During the course of the study the following examinations will be done: history and general physical examination, gynecological examination and ultrasound, WHO performance status, laboratory analysis ( serum CA 125, Hb, Ht and albumine) abdominal-pelvic computed tomography (CAT scan) and the QLQ OV 28. Patient registration The following items will be registered: institution and responsible physician, initials of the patient, birthday and hospital record number, date of last chemotherapy cycle (and type of chemotherapy), date of diagnosis of recurrence, stage of disease at initial diagnosis (FIGO), number of measurable lesions and largest diameter, WHO performance status, peritonitis or ascites present at initial surgery and tumor-diameter after initial surgery (no, 0-1 cm, >1 cm) Statistical considerations With a power analysis we calculated that 522 patients must be randomized in a period of 5 years. Assuming that 75% of the patients will reach the randomization procedure 700 patients should be registered. This means that 140 patients should be registered each year.
- Main changes (audit trail)
- RECORD17-okt-2005 - 7-mrt-2006


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