Secondary cytoreductive surgery added to chemotherapy will increase progression free survival in selected patients with first platinum sensitive recurrence of ovarian cancer with a minimal negative effect on their health-related quality of life.
ID
Bron
Verkorte titel
Aandoening
Ovarian cancer Platinum sensitive Recurrence Cytoreductive surgery/debulking Ovariumcarcinoom Platinum sensitief Recidief Cytoreductieve chirurgie/debulking
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Progression free survival.
Achtergrond van het onderzoek
Recruitment: The Netherlands.
Summary:
There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. The most active chemotherapy in platinum sensitive recurrent ovarian cancer provides only a limited activity with a median overall survival of 29 months. When tumor resection was complete, survival rates up to 62 months are reported, in series with highly selected patients with recurrent ovarian cancer. Whether cytoreductive surgery in recurrent ovarian cancer is valuable even in less highly selected patients is questionable. A randomized controlled trial, to investigate if secondary cytoreductive surgery added to chemotherapy will increase progression free survival in selected patients with first recurrence of ovarian cancer, is needed.
Doel van het onderzoek
Secondary cytoreductive surgery added to chemotherapy will increase progression free survival in selected patients with first platinum sensitive recurrence of ovarian cancer with a minimal negative effect on their health-related quality of life.
Onderzoeksopzet
1. Progression free survival: Defined as the interval between date of randomization and date of progressive disease or death of any cause, whatever occurs first;
2. Overall survival: time between the day of randomization and death of any cause
quality of life;
3. Tumor response: GCIG criteria and RECIST criteria;
4. Peri-operative morbidity and mortality: Any undesirable experience occurring to a subject during surgery and/or follow-up (within 6 weeks after surgery), whether or not considered related to secondary cytoreductive surgery. All adverse events reported spontaneously by the subject or observed by the investigator or his staff will be reported;
5. Quality of life: For the evaluation of health-related quality of life, the EORTC (European Organization for Research and Treatment of Cancer) Core Questionnaire, the QLQ-C30 version 3.0 the supplemental ovarian cancer-specific module, the QLQ-OV28 (19) and EQ-5D-3L (31) will be used. The pre-treatment questionnaire must be filled in at baseline, after informed consent and preferably before randomization. In the experimental arm the subsequent questionnaire is filled in after secondary cytoreductive surgery just before the start of the first cycle of chemotherapy. In both arms subsequent questionnaires are filled in after the 6th cycle of chemotherapy and 3, 6, 9, 12, 18 and 24 months following treatment.
Onderzoeksproduct en/of interventie
Patients in the control arm receive the standard treatment for recurrent ovarian cancer of at least six cycles of intravenous platinum containing chemotherapy.
In the experimental arm treatment consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum containing chemotherapy.
Publiek
Dept of gynecology<br>
G.Grooteplein 10
R. Laar, van de
Nijmegen 6525 GA
The Netherlands
+31 (0)24 3614755
r.vandelaar@obgyn.umcn.nl
Wetenschappelijk
Dept of gynecology<br>
G.Grooteplein 10
R. Laar, van de
Nijmegen 6525 GA
The Netherlands
+31 (0)24 3614755
r.vandelaar@obgyn.umcn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ≥ 18 years;
2. First recurrence of histologically or cytologically proven epithelial ovarian cancer, primaryperitoneal cancer or fallopian tube cancer of FIGO stage Ic-IV (FIGO system 1988);
3. First-line treatment consisted of complete or optimal (≤ 1 cm) cytoreductive surgery and a minimum of six courses (neo-adjuvant) platinum-taxol based chemotherapy;
4. A clinically disease-free interval of at least 6 months after end of first-line treatment, the latter defined as the day the last chemotherapy was administered;
5. First recurrence defined as clinical and radiological signs (CT-scan) of recurrence or elevated CA 125 (GCIG criteria) and radiological signs (CT-scan);
6. If there is any doubt whether or not an abnormal finding on CT-scan is recurrent ovarian cancer, confirmation of recurrence with cytological or histological investigation is warranted;
7. Good performance status (ECOG 0-1);
8. Ascites < 500 ml (pocket < 8 cm on ultrasound examination);
9. Complete resection seems possible (estimated by a gynecologic oncologist);
10. Adequate hematological, renal, and hepatic function to permit platinum based chemotherapy: WBC > 3.0 x 10⁹/L, platelets > 100 x 10⁹/L, serum creatinine < 1.25 x upper normal range (40-90 micromol/L), serum bilirubin < 1.25 x upper normal range (< 17 micromol/L);
11. Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution before randomization;
12. Quality of life baseline questionnaires should be filled in after informed consent, preferably before randomization but at least before start treatment.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Participation in interfering trial;
2. Non-epithelial or borderline ovarian tumours;
3. Other primary malignancy except for carcinoma in situ and basal or squamous cell carcinoma of the skin;
4. Patients with platinum-refractory or resistant tumours;
5. Intra-abdominal metastatic disease that hampers complete cytoreduction;
6. Extra-abdominal metastatic disease that hampers complete cytoreduction;
7. Palliative surgery already planned (e.g. bowel surgery);
8. Patients with secondary, third and later recurrence;
9. Any disease, medical history or medication not allowing surgery and/or platinum based chemotherapy;
10. Prior therapy with respect to recurrence.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3137 |
| NTR-old | NTR3337 |
| CCMO | NL36413.091.11 |
| OMON | NL-OMON35952 |