Treatment Strategies for Primarily Generalized Colorectal Cancer

NCT01056809 | Terminated

• 1 other identifier: PGC-8
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 10

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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Metastases; Treatment strategies; Colorectal cancer with synchronous metastases

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 years after completion of study

Secondary Outcomes (5)

• 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

Study Arms (2)

Traditional strategy

ACTIVE COMPARATOR

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

Procedure: Chemotherapy and surgery

Alternative strategy

ACTIVE COMPARATOR

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

Interventions

Chemotherapy and surgery PROCEDURE

Treatment not specified but in accordance with national guidelines

Alternative strategy; Traditional strategy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrinnevi Hospital: lead
• Medical Research Council of Southeast Sweden: collaborator

Study Sites (10)

Höglandssjukhuset

Eksjö, SE 57581, Sweden

Location

Department of Surgery

Gävle - Hudiksvall, Sweden

Location

Länssjukhuset Ryhov

Jönköping, SE 55185, Sweden

Location

Länssjukhuset

Kalmar, SE 39185, Sweden

Location

Universitetssjukhuset

Linköping, SE 58185, Sweden

Location

Vrinnevisjukhuset

Norrköping, SE 601 82, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, SE 17176, Sweden

Location

Akademiska sjukhuset

Uppsala, SE 75185, Sweden

Location

Värnamo sjukhus

Värnamo, SE 33185, Sweden

Location

Centrallasarettet

Västerås, SE 72189, Sweden

Location

Related Publications (4)

• 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.

  PMID: 16671066 BACKGROUND

• 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.

  PMID: 10560850 BACKGROUND

• 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.

  PMID: 16035135 BACKGROUND

• 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.

  PMID: 18662955 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Drug Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gunnar Arbman, MD, PhD

  Department of Surgery in Östergötland

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant surgeon

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

SE (10)