To compare the Efficacy of additional Tumor DebulKing Surgery versus chemotherapy alone in recurrent Platinum-sensitive Ovarian cancer

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: DESKTOP III is a surgery based trial and does not involve any Investigational medicinal products (IMPs): Patients will be randomised into one of two treatment groups: Group A: Surgery (with the aim of complete tumour removal) followed by chemotherapy. The extent of surgery in Group A is difficult to estimate beforehand as it depends how much the tumour has spread. However, the aim is complete tumour removal. These tumours can spread into the whole abdominal cavity, the peritoneum, the intestine, the organs of the upper abdomen and also into the lymph nodes. Secondary surgery may therefore include the removal of these affected parts or further actions if it is an extensive tumour. Patients randomised to Group A, will recover from surgery and will receive chemotherapy. After surgery, patients in Group A will receive the normal treatment and care under the attending doctor. Group B: Chemotherapy only. Patients in Group B will have their treatment and care carried out as normal (as if they weren't in the trial) under the medical care of their attending doctor. For Group B patients, if after chemotherapy it is thought that they may still benefit from surgery, this will certainly be possible. Patients will be interviewed 60 days after the start of the treatment and then followed up by a doctor. The follow up process will be quarterly for 2 years, 6 monthly for 5 years and then annually. CONDITION: Ovarian Cancer ; Cancer ; Malignant neoplasm of ovary PRIMARY OUTCOME: Overall survival (OS) in patients with platinum‐sensitive recurrent ovarian cancer with a positive AGO‐score randomized to cytoreductive surgery followed by chemotherapy of the physician's choice versus chemotherapy of the physician's choice alone (recommended: platinum combination therapy). Overall survival is defined as the interval between date of randomisation and date of death. SECONDARY OUTCOME: 1. Quality of Life at baseline, 6, and 12 months after randomization assessed by EORTC QLQ 30 and FACT NCCN Ovarian Symptom Index (if available in the language of the participating centre).; 2. Progression‐free‐survival in treatment groups. Progression free survival is defined as interval between date of randomisation and 2nd relapse/progression or death (whatever occurs first). Tumor progression is defined as progressive disease according to Response Evaluation Criteria In Solid Tumors (RECIST) or Gynecologic Cancer Intergroup (GCIG) criteria or death without progression or clinical deterioration of performance status with associated signs of disease (e.g. bowel obstruction and non‐measurable disease).; 3. Rate of complete resection as prognostic factor; 4. Complication rate associated with surgery until definitive hospital discharge (Reattendance within 1 week for surgical complications counts as one hospital stay).; 5. Exploratory analysis of surgical characteristics and applied chemotherapy; 6. Predictive and prognostic value of cancer antigen‐125 (CA‐125) INCLUSION CRITERIA: 1. Patients with first recurrence of platinum sensitive, invasive epithelial ovarian‐, fallopian tube‐ or primary peritoneal cancer of any initial stage 2. Progression‐free interval of at least 6 months after end of last platinum‐containing therapy, or recurrence within 6 months or later after primary surgery if the patient has not received prior chemotherapy in patients with International Federation of Gynecology and Obstetrics (FIGO) stage I. Non cytostatic maintenance therapy not containing platinum will not be considered for this calculation 3. A positive AGO‐score. Obligatory requirements for a positive AGO recurrence score in platinum‐sensitive disease: Performance status Eastern Cooperative Oncology Group (ECOG) 0. No residual tumor after primary surgery (if unknown, alternatively primary FIGO stage I / II). If report from 1st surgery is not available contact study chairman who will decide whether inclusion is possible or not. Absence of ascites (cut of
Epistemonikos ID: dcbdd3f5e65204eb107d8901dbe1a1b759664cc8
First added on: Aug 22, 2024