Treatment Strategies for Primarily Generalized Colorectal Cancer (PGC)

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Chemotherapy and surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Eksjö, Sweden, SE 57581
    • Höglandssjukhuset
  • Gävle - Hudiksvall, Sweden
    • Department of Surgery
  • Jönköping, Sweden, SE 55185
    • Länssjukhuset Ryhov
  • Kalmar, Sweden, SE 39185
    • Länssjukhuset
  • Linköping, Sweden, SE 58185
    • Universitetssjukhuset
  • Norrköping, Sweden, SE 601 82
    • Vrinnevisjukhuset
  • Stockholm, Sweden, SE 17176
    • Karolinska Universitetssjukhuset
  • Uppsala, Sweden, SE 75185
    • Akademiska Sjukhuset
  • Värnamo, Sweden, SE 33185
    • Värnamo sjukhus
  • Västerås, Sweden, SE 72189
    • Centrallasarettet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	3 years after completion of study

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Vrinnevi Hospital
• Collaborators: 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, Uppsala University

Publications and helpful links

General Publications

• Mentha G, Majno PE, Andres A, Rubbia-Brandt L, Morel P, Roth AD. Neoadjuvant chemotherapy and resection of advanced synchronous liver metastases before treatment of the colorectal primary. Br J Surg. 2006 Jul;93(7):872-8. doi: 10.1002/bjs.5346.
• Scoggins CR, Meszoely IM, Blanke CD, Beauchamp RD, Leach SD. Nonoperative management of primary colorectal cancer in patients with stage IV disease. Ann Surg Oncol. 1999 Oct-Nov;6(7):651-7. doi: 10.1007/s10434-999-0651-x.
• Benoist S, Pautrat K, Mitry E, Rougier P, Penna C, Nordlinger B. Treatment strategy for patients with colorectal cancer and synchronous irresectable liver metastases. Br J Surg. 2005 Sep;92(9):1155-60. doi: 10.1002/bjs.5060.
• Scheer MG, Sloots CE, van der Wilt GJ, Ruers TJ. Management of patients with asymptomatic colorectal cancer and synchronous irresectable metastases. Ann Oncol. 2008 Nov;19(11):1829-35. doi: 10.1093/annonc/mdn398. Epub 2008 Jul 28.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 31, 2012
• Last Update Submitted That Met QC Criteria: May 30, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Colorectal cancer; Metastases; Treatment strategies; Colorectal cancer with synchronous metastases
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PGC-8