Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Metastases, Treatment strategies, Colorectal cancer with synchronous metastases
Brief summary
For patients with primarily generalized colorectal cancer two treatment strategies are compared to establish which strategy gives best overall survival. The traditional strategy is to first resect the primary colorectal tumour and then treat the metastases with chemotherapy followed if possible by surgery. The alternative strategy is to first treat the metastases with chemotherapy followed if possible by surgery and only resect the primary colorectal tumour if there is hope for cure or if symptoms develop that necessitates treatment.
Detailed description
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.
Interventions
PROCEDUREChemotherapy and surgery
Treatment not specified but in accordance with national guidelines
Sponsors
Medical Research Council of Southeast Sweden
Vrinnevi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years after completion of study |
Secondary
| Measure | Time frame |
|---|---|
| 3 year survival for patients treated with curative intent | 3 years after randomization |
| Palliative patients not receiving chemotherapy treated with the traditional strategy | Completion of study |
| Quality of life | Every 6 months up to 3 years |
| Health care consumption | Completion of study |
| Complications and side effects | Completion of study |
Countries
Sweden
Outcome results
None listed