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Health Condition(s) or Problem
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Ovarian Cancer
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Lay Summary
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Background:
Previous studies have shown significant survival benefit in patients with complete macroscopic cytoreduction whilst the AGO score appears to reliably predict complete resectability in this population of patients. However, it is unclear if both the AGO score or complete resectability at late cytoreduction merely reflect a less aggressive biological variable of the tumour and thus might achieve the same outcome with chemotherapy alone. The alternative is that surgery confers a real benefit.
Aims:
1. To compare overall survival in patients with platinum sensitive recurrent ovarian cancer with a positive AGO-score randomized to tumour debulking surgery followed by chemotherapy of physician’s choice versus chemotherapy of physician’s choice alone.
2. Quality of Life. To compare progression-free-survival in treatment groups. To analyze complications associated with surgery and perioperative mortality in patients with relapsed ovarian cancer in a multicenter setting. Exploratory analysis of surgical and treatment characteristics.
Summary of proposed study:
This is an open-label, prospective, randomized, international, multicentre phase III surgery trial following an international protocol developed in Germany. 408 patients (204/group) will be randomized to experimental or control treatment in a 1:1 ratio over a period of 30 months. All participants will be followed up until observation of 244 events, which is expected at 36 months after randomization of the last patient (i.e. 72 months after start of the trial). The UK is expected to recruit approximately 100 of the total patients. (from UKCRN Portfolio)
Additional lay summaries...
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Who can enter the trial
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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 off < 500 ml: radiological or ultrasound estimation).
4. Women aged more than or equal to 18 years
5. Complete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by magetic resonance imaging (MRI) / computerised tomography (CT) if other surgical approaches for isolated extra-abdominal recurrences are planned
6. Patients who have given their signed and written informed consent and their consent to data transmission and -processing
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Who cannot enter the trial
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1. Patients with non-epithelial tumors as well as borderline tumors
2. Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
3. More than one prior chemotherapy
4. Patients with second, third, or later recurrence
5. Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected
6. Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum containing therapy
7. Only palliative surgery planned
8. Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible)
9. Any concomitant disease not allowing surgery and / or chemotherapy
10. Any medical history indicating excessive peri-operative risk
11. Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)
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What will happen
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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.
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Primary aim
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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.
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Secondary Aim
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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)
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Participant Information Sheet
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Not available in web format, please use the contact details below to request a patient information sheet
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Birmingham
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