Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326619
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-17
Brief Title:
Survival Benefit of Primary Tumour Resection Compared to Systemic Therapy Alone in Stage IV Colorectal Cancer Patients
Sponsor:
Medizinische Hochschule Brandenburg Theodor Fontane
Organization:
Medizinische Hochschule Brandenburg Theodor Fontane
Study Overview
Official Title:
Survival Benefit of Palliative Primary Tumor Resection and Systemic Therapy Versus Systemic Therapy Only Among Patients With Stage IV Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SurvSysT
Brief Summary:
About 20-25 percent of all colorectal cancer patients are diagnosed with International Union Against Cancer UICC stage IV disease The benefit of primary tumor resection in the palliative context is therefore of high concern However empirical evidence from randomized and observational studies is inconsistent
The objective of the present study is to compare the survival of palliative stage IV colorectal cancer patients selected for primary tumor resection and systemic treatment PTRSYST to patients with systemic treatment only SYST
The objective of the present study is to compare the survival of palliative stage IV colorectal cancer patients selected for primary tumor resection and systemic treatment PTRSYST to patients with systemic treatment only SYST
Detailed Description:
Mortality after PTRSYST compared to SYST alone was evaluated in a retrospective observational cohort of patients diagnosed from 2012-2020 in the cancer registry in the federal state of Brandenburg Germany excluding patients with rectal cancer of the lower two-thirds emergency procedures unknown Eastern Cooperative Oncology Group Score ECOG status ECOG2 unknown metastatic status or unclear grading
PTR was defined as resection of the primary tumor within 12 months after diagnosis German procedure codes Operationen- und Prozedurencodes OPS 5-455 5-456 5-484 5-485 Cases with additional but incomplete resection of metastases were included SYST was defined as the application of chemotherapy antibody or immunotherapy alone or in combination starting within 12 months after diagnosis
The primary study endpoint was mortality Survival of treatment groups PTRSYST vs SYST was compared using Kaplan-Meier survival plots and log-rank tests Follow-up started at diagnosis and ended at death or December 31 2020 whichever came first Hazard ratios HR were calculated with multivariate Cox regression adjusting for sex male female age at diagnosis in years ECOG status 0 1 2 localization and number of metastases according to TNM 8th edition M1a M1b M1c grading G1-2 G3-4 and localization of the primary tumor colon carcinoma on the right side colon carcinoma on the left side or rectum carcinoma upper third
Sensitivity analyses were performed to reduce indication bias Propensity score matching was conducted based on a propensity score determined by logistic regression of treatment PTRSYST vs SYST on the same variables as above plus radiotherapy yesno For each patient in the SYST group a patient from the PTRSYST group was randomly chosen with the same propensity score as the SYST patient within a certain margin The same analyses as above were performed on the matched patient groups Delayed entry was used to account for the fact that patients who underwent PTR must survive from the date of diagnosis to the date of surgery to be included in the PTRSYST group whereas no such requirement was made for patients in the SYST group Follow-ups started 3 6 9 and 12 months after diagnosis excluding patients who died prior to this time irrespective of treatment according to the landmark approach as described by Alawadi et al 2017
Registry quality assurance measures and procedures
Quality of German Clinical Cancer Registries have been analysed and described in detail by various publications for example PubMed-ID PMID 37568750 PMID 28639952 PMID 26474650 PMID 25523845 In summary the completeness and quality of the data can be rated as high to very high The basis for this are the statutory reporting requirements a high reporting fee by European standards for both the registries and the transmitting agent regular quality conferences highly standardised documentation requirements for the data transmission specifications on register-related quality indicators eg completeness internal data validation measures and a secure and independent funding basis
PTR was defined as resection of the primary tumor within 12 months after diagnosis German procedure codes Operationen- und Prozedurencodes OPS 5-455 5-456 5-484 5-485 Cases with additional but incomplete resection of metastases were included SYST was defined as the application of chemotherapy antibody or immunotherapy alone or in combination starting within 12 months after diagnosis
The primary study endpoint was mortality Survival of treatment groups PTRSYST vs SYST was compared using Kaplan-Meier survival plots and log-rank tests Follow-up started at diagnosis and ended at death or December 31 2020 whichever came first Hazard ratios HR were calculated with multivariate Cox regression adjusting for sex male female age at diagnosis in years ECOG status 0 1 2 localization and number of metastases according to TNM 8th edition M1a M1b M1c grading G1-2 G3-4 and localization of the primary tumor colon carcinoma on the right side colon carcinoma on the left side or rectum carcinoma upper third
Sensitivity analyses were performed to reduce indication bias Propensity score matching was conducted based on a propensity score determined by logistic regression of treatment PTRSYST vs SYST on the same variables as above plus radiotherapy yesno For each patient in the SYST group a patient from the PTRSYST group was randomly chosen with the same propensity score as the SYST patient within a certain margin The same analyses as above were performed on the matched patient groups Delayed entry was used to account for the fact that patients who underwent PTR must survive from the date of diagnosis to the date of surgery to be included in the PTRSYST group whereas no such requirement was made for patients in the SYST group Follow-ups started 3 6 9 and 12 months after diagnosis excluding patients who died prior to this time irrespective of treatment according to the landmark approach as described by Alawadi et al 2017
Registry quality assurance measures and procedures
Quality of German Clinical Cancer Registries have been analysed and described in detail by various publications for example PubMed-ID PMID 37568750 PMID 28639952 PMID 26474650 PMID 25523845 In summary the completeness and quality of the data can be rated as high to very high The basis for this are the statutory reporting requirements a high reporting fee by European standards for both the registries and the transmitting agent regular quality conferences highly standardised documentation requirements for the data transmission specifications on register-related quality indicators eg completeness internal data validation measures and a secure and independent funding basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None