Treatment Strategies for Primarily Generalized Colorectal Cancer (PGC)

This study has been terminated.
(Too slow recruitment)
Sponsor:
Collaborator:
Medical Research Council of Southeast Sweden
Information provided by (Responsible Party):
Gunnar Arbman, Vrinnevi Hospital
ClinicalTrials.gov Identifier:
NCT01056809
First received: January 25, 2010
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Colorectal Cancer
Procedure: Chemotherapy and surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies

Resource links provided by NLM:


Further study details as provided by Vrinnevi Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 years after completion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3 year survival for patients treated with curative intent [ Time Frame: 3 years after randomization ] [ Designated as safety issue: No ]
  • Palliative patients not receiving chemotherapy treated with the traditional strategy [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Every 6 months up to 3 years ] [ Designated as safety issue: No ]
  • Health care consumption [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Complications and side effects [ Time Frame: Completion of study ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: January 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional strategy
First resection of the primary colorectal tumour, then treatment of metastases with chemotherapy and if possible surgery.
Procedure: Chemotherapy and surgery
Treatment not specified but in accordance with national guidelines
Active Comparator: Alternative strategy
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
Procedure: Chemotherapy and surgery
Treatment not specified but in accordance with national guidelines

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056809

Locations
Sweden
Höglandssjukhuset
Eksjö, Sweden, SE 57581
Department of Surgery
Gävle - Hudiksvall, Sweden
Länssjukhuset Ryhov
Jönköping, Sweden, SE 55185
Länssjukhuset
Kalmar, Sweden, SE 39185
Universitetssjukhuset
Linköping, Sweden, SE 58185
Vrinnevisjukhuset
Norrköping, Sweden, SE 601 82
Karolinska Universitetssjukhuset
Stockholm, Sweden, SE 17176
Akademiska sjukhuset
Uppsala, Sweden, SE 75185
Värnamo sjukhus
Värnamo, Sweden, SE 33185
Centrallasarettet
Västerås, Sweden, SE 72189
Sponsors and Collaborators
Vrinnevi Hospital
Medical Research Council of Southeast Sweden
Investigators
Principal Investigator: Gunnar Arbman, MD, PhD Department of Surgery in Östergötland
Study Chair: Per Sandström, MD, PhD Department of Surgery in Östergötland
Study Chair: Hans Starkhammar, MD, PhD Regional Oncologic Center, Linköping
Study Chair: Bengt Glimelius, Professor University of Uppsala, The Karolinska University Hospital, Stockholm
Study Chair: Lars Lundell, Professor The Karolinska University Hospital, Stockholm
Study Chair: Per-Olof Nyström, Professor The Karolinska Universtiy Hospital, Stockholm
Study Chair: Ulf Gunnarsson, Professor The Karolinska University hospital, Stockholm
Study Chair: Lars Påhlman, Professor University of Uppsala
  More Information

Publications:
Responsible Party: Gunnar Arbman, Consultant surgeon, Vrinnevi Hospital
ClinicalTrials.gov Identifier: NCT01056809     History of Changes
Other Study ID Numbers: PGC-8
Study First Received: January 25, 2010
Last Updated: May 30, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Vrinnevi Hospital:
Colorectal cancer
Metastases
Treatment strategies
Colorectal cancer with synchronous metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 24, 2014