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ID
Source
Brief title
Health condition
Colorectal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main aim of this study is to determine whether prophylactic bilateral salpingo-oophorectomy conducted in postmenopausal patients aged ≥60 years during surgery for primary CRC reduces the incidence of ovarian malignancies (metastatic or primary) during a three-year follow-up period. Moreover, this study will provide the data necessary to calculate the number needed to treat (NNT) in order to prevent one case of ovarian cancer (metastatic or primary).
Secondary outcome
What is the effect of PSO on disease-free survival (DFS) after 3-years of follow-up? What is the concomitant NNT to gain one year of DFS.
What is the effect of PSO on surgery-related morbidity?
In the non-PSO group, what is the incidence and pattern of intra-abdominal relapse, including CRC ovarian metastases and primary ovarian cancer, requiring renewed surgical intervention?
During primary surgery, how often are abnormal ovaries found that require resection?
What is the incidence of (micro)metastatic disease in the ovaries of patients with primary CRC?
What is the effect of PSO on quality of life as assessed using health-related quality of life (HRQL) questionnaires, and on long-term effects such as surgery for abdominal adhesions occurring within 3 years?
What is the effect of PSO on 3-year survival?
What is the percentage of patients who have a preference for PSO (or no PSO) when scheduled for surgery for primary CRC? Within 3 years of their index surgery, how many patients revise their initial decision of no PSO and subsequently undergo PSO?
Are there differences in the baseline characteristics between patients who choose PSO compared to those who do not?
The baseline patient characteristics include age, ASA-classification, BMI, previous unilateral oophorectomy, comorbidities, and neo-adjuvant therapy.
Background summary
Background: The mean incidence of ovarian metastases (OM) in patients with colorectal cancer (CRC) is 3.4%. The 5-year survival of these patients, even when operated with curative intent, is remarkably low. The lifetime risk of ovarian cancer is approximately 1.3%. Prophylactic salpingo-oophorectomy (PSO, or surgical removal of the ovaries and fallopian tubes) could reduce the number of CRC patients that develop OM after removal of the primary tumor, as well as preventing the occurrence of primary ovarian cancer. Recently, the care pathway for CRC has been changed in several hospitals in line with the updated Dutch guideline. The possibility of PSO is now discussed with postmenopausal CRC patients in these hospitals. The aims of the current study are firstly to estimate the incidence of OM and primary ovarian cancer in postmenopausal patients with CRC, and secondly to evaluate the effect of PSO in these patients.
Methods/design: An information bulletin and decision guide on this topic was implemented in several Dutch hospitals in 2020. Post-decision outcomes will be collected prospectively. The study population consists of postmenopausal (≥ 60 years of age) patients that are operated with curative intent for CRC. Based on their own preference, patients will be divided into two groups: those who choose to undergo PSO and those who do not. The main study parameters are the reduction in incidence of ovarian malignancies (metastatic or primary) following PSO, and the number needed to treat (NNT) by PSO to prevent one case of ovarian malignancy.
Discussion: This will be the first study to evaluate the effect of PSO in postmenopausal CRC patients that is facilitated by an altered CRC care pathway. The results of this study are expected to provide relevant information on whether PSO adds significant value to postmenopausal patients with CRC.
Study objective
Patients who received prophylactic salpingo-oophorectomy will have a better 3-year disease free survival compared to patients who didn't receive prophylactic salpingo-oophorectomy
Study design
- August 2020: start of gathering data
- december 2023: final inclusion
Intervention
This study evaluates the effect of an existing procedure implemented in the local CRC pathway as follows: prophylactic salpingo-oophorectomy versus standard care in a female population with colorectal cancer.
Richard van der Meer
0408888550
richard.van.der.meer@mmc.nl
Richard van der Meer
0408888550
richard.van.der.meer@mmc.nl
Inclusion criteria
1. Female gender
2. Age ≥60 years at the time of CRC diagnosis
3. Intended curative resection of colon or rectal cancer, with no evidence of incurable distant metastases
4. informed consent or consent by opt-in form
Exclusion criteria
1. No signed informed consent and no consent by opt-in form
2. surgery with palliative intent
3. Known distant metastases preoperatively, or evidence of distant or intraperitoneal metastases during operation, except when curative metastasectomy is considered possible
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7870 |
| Other | METC MMC : 2021-MMC-058 |