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Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies


N/A
N/A
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies


Patients are randomized between the two treatment strategies mentioned above. After initial
treatment the patients are categorized as palliative or treated with curative intent.
Patients are followed with quality of life evaluations every 6 months. Outpatient visits,
hospital care, examinations and treatment are recorded as well as complications and side
effects. Survival is recorded and for those patients treated with curative intent the tumour
situation 3 years after randomization is evaluated.


Inclusion Criteria:



- Patients with primarily generalized colorectal cancer diagnosed by pathology or
typical appearance on x-ray or at endoscopy and where there is uncertainty regarding
best treatment strategy

Exclusion Criteria:

- Patients not willing to participate or unable to sign informed consent.

- Patients with other malignancy with metastatic potential

- Patients where synchronous resection of primary tumour and metastases is planned

- Patients not fit for chemotherapy or surgery

- Patients with locally unresectable primary tumours

- Patients with symptoms from primary colorectal tumour necessitating resection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

3 years after completion of study

Safety Issue:

No

Principal Investigator

Gunnar Arbman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery in Östergötland

Authority:

Sweden: The National Board of Health and Welfare

Study ID:

PGC-8

NCT ID:

NCT01056809

Start Date:

January 2010

Completion Date:

May 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Metastases
  • Treatment strategies
  • Colorectal cancer with synchronous metastases
  • Colorectal Neoplasms

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