Treatment Strategies for Primarily Generalized Colorectal Cancer (PGC)

Vrinnevi Hospital

Status: Terminated

Conditions: Colorectal Cancer

Treatments: Procedure: Chemotherapy and surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01056809

PGC-8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Traditional strategy

Active Comparator group

Description:

First resection of the primary colorectal tumour, then treatment of metastases with chemotherapy and if possible surgery.

Treatment:

Procedure: Chemotherapy and surgery

Alternative strategy

Active Comparator group

Description:

First treatment of metastases with chemotherapy and if possible surgery, later resection of primary colorectal tumour if hope for cure or if symptoms develope that necessitates treatment

Treatment:

Procedure: Chemotherapy and surgery