Survival Benefit of Primary Tumour Resection Compared to Systemic Therapy Alone in Stage IV Colorectal Cancer Patients

NCT06326619 | Completed

• 1 other identifier: SurvSysT
• Study Type: observational
• Target: 480
• Locations: 0 countries
• Sites: N/A

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 (PTR+SYST) to patients with systemic treatment only (SYST).

Conditions

Colorectal Cancer; Neoadjuvant Systemic Therapy

Keywords

Survival Analysis; Palliative Care; Primary Tumor Resection

Outcome Measures

Primary Outcomes (1)

• Survival

  No mortality; no death by any cause; overall survival

  5-year follow up

Study Arms (2)

SYST

Systemic treatment only. Systemic treatment was defined as the application of chemotherapy, antibody, or immunotherapy (alone or in combination) starting within 12 months after diagnosis (definition for both groups)

Procedure: Systemic Therapy

PTR+SYST

primary tumor resection and systemic treatment At least one of the following surgical procedures were performed: German procedure codes OPS 5-455.\*, 5-456.\*, 5-484.\*, 5-485.\*

Procedure: Primary tumor resection; Procedure: Systemic Therapy

Interventions

Primary tumor resection PROCEDURE

In addition to systemic therapy a primary tumor resection was performed.

PTR+SYST

Systemic Therapy PROCEDURE

chemotherapy, antibody, or immunotherapy (alone or in combination) starting within 12 months after diagnosis

PTR+SYST; SYST

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Complete residential population of the federal states Brandenburg and Berlin, Germany.

You may qualify if:

• diagnosed colorectal carcinoma
• stage IV
• systemic therapy, starting within 12 months after diagnosis

You may not qualify if:

• rectal cancer of the lower two-thirds
• emergency procedures
• unknown Eastern Cooperative Oncology Group (ECOG) performance status
• ECOG\>2
• unknown metastatic status
• unclear grading

Sponsors & Collaborators

• Medizinische Hochschule Brandenburg Theodor Fontane: lead
• Clinical-Epidemiological Cancer Registry Brandenburg-Berlin: collaborator

Related Publications (1)

• Mantke R, Schneider C, von Ruesten A, Hauptmann M. Patients with stage IV colorectal carcinoma selected for palliative primary tumor resection and systemic therapy survive longer compared with systemic therapy alone: a retrospective comparative cohort study. Int J Surg. 2024 Oct 1;110(10):6493-6500. doi: 10.1097/JS9.0000000000001838.

  PMID: 38935125 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rene Mantke, M.D.

  Medizinische Hochschule Brandenburg CAMPUS GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: January 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share