To compare the Efficacy of additional Tumor DebulKing Surgery versus chemotherapy alone in recurrent Platinum-sensitive Ovarian cancer
| ISRCTN | ISRCTN39361386 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39361386 |
| ClinicalTrials.gov number | NCT01166737 |
| Secondary identifying numbers | AGO-OVAR-ID:AGO-OVAR OP.4 (DESKTOP III) |
- Submission date
- 24/05/2011
- Registration date
- 04/08/2011
- Last edited
- 01/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof David Luesley
Scientific
Scientific
Reproductive and Child Health
Pan-Birmingham Gynae. Cancer Centre
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
| davidluesley@nhs.net |
Study information
| Study design | Open label prospective randomised multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised multicentre study to compare the Efficacy of additional Tumor DebulKing Surgery versus chemotherapy alone in recurrent Platinum-sensitive Ovarian cancer |
| Study acronym | DESKTOP III |
| Study objectives | The hypothesis H0: "no difference in the survival probability between treatment groups at any time" will be tested against the alternative H1: "difference in survival probability between groups". |
| Ethics approval(s) | Approval pending as of 25/05/2011 |
| Health condition(s) or problem(s) studied | Ovarian Cancer |
| 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 01/10/2011 |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 408 |
| Total final enrolment | 407 |
| Key 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 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 |
| Key exclusion criteria | 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) |
| Date of first enrolment | 01/10/2011 |
| Date of final enrolment | 01/10/2014 |
Locations
Countries of recruitment
- England
- Germany
- United Kingdom
Study participating centre
City Hospital
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Sponsor information
AGO Research GmbH (Germany)
Industry
Industry
c/o Philipp Harter, MD
Kaiser-Friedrich-Ring 71
Wiesbaden
65185
Germany
| office-wiesbaden@ago-ovar.de | |
| Website | http://www.ago-ovar.de |
"ROR" |
https://ror.org/01jdhsq12 |
Funders
Funder type
Charity
Clinical Trials Awards and Advisory Committee (CTAAC) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at ASCO | 20/05/2017 | 15/04/2019 | No | No |
| Plain English results | 01/07/2021 | No | Yes |
Editorial Notes
01/07/2021: Cancer Research UK lay results summary link added to Results (plain English).
15/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added.
3. The Clinicaltrials.gov number has been added.
