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Treatment Strategies for Primarily Generalized Colorectal Cancer (PGC)

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Chemotherapy and surgery
Sponsored by
Vrinnevi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Metastases, Treatment strategies, Colorectal cancer with synchronous metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Höglandssjukhuset
  • Department of Surgery
  • Länssjukhuset Ryhov
  • Länssjukhuset
  • Universitetssjukhuset
  • Vrinnevisjukhuset
  • Karolinska Universitetssjukhuset
  • Akademiska sjukhuset
  • Värnamo sjukhus
  • Centrallasarettet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Traditional strategy

Alternative strategy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

3 year survival for patients treated with curative intent
Palliative patients not receiving chemotherapy treated with the traditional strategy
Quality of life
Health care consumption
Complications and side effects

Full Information

First Posted
January 25, 2010
Last Updated
May 30, 2012
Sponsor
Vrinnevi Hospital
Collaborators
Medical Research Council of Southeast Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01056809
Brief Title
Treatment Strategies for Primarily Generalized Colorectal Cancer
Acronym
PGC
Official Title
Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Too slow recruitment
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrinnevi Hospital
Collaborators
Medical Research Council of Southeast Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Metastases, Treatment strategies, Colorectal cancer with synchronous metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional strategy
Arm Type
Active Comparator
Arm Description
First resection of the primary colorectal tumour, then treatment of metastases with chemotherapy and if possible surgery.
Arm Title
Alternative strategy
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy and surgery
Intervention Description
Treatment not specified but in accordance with national guidelines
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years after completion of study
Secondary Outcome Measure Information:
Title
3 year survival for patients treated with curative intent
Time Frame
3 years after randomization
Title
Palliative patients not receiving chemotherapy treated with the traditional strategy
Time Frame
Completion of study
Title
Quality of life
Time Frame
Every 6 months up to 3 years
Title
Health care consumption
Time Frame
Completion of study
Title
Complications and side effects
Time Frame
Completion of study

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Arbman, MD, PhD
Organizational Affiliation
Department of Surgery in Östergötland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per Sandström, MD, PhD
Organizational Affiliation
Department of Surgery in Östergötland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hans Starkhammar, MD, PhD
Organizational Affiliation
Regional Oncologic Center, Linköping
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bengt Glimelius, Professor
Organizational Affiliation
University of Uppsala, The Karolinska University Hospital, Stockholm
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lars Lundell, Professor
Organizational Affiliation
The Karolinska University Hospital, Stockholm
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Per-Olof Nyström, Professor
Organizational Affiliation
The Karolinska Universtiy Hospital, Stockholm
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulf Gunnarsson, Professor
Organizational Affiliation
The Karolinska University hospital, Stockholm
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lars Påhlman, Professor
Organizational Affiliation
Uppsala University
Official's Role
Study Chair
Facility Information:
Facility Name
Höglandssjukhuset
City
Eksjö
ZIP/Postal Code
SE 57581
Country
Sweden
Facility Name
Department of Surgery
City
Gävle - Hudiksvall
Country
Sweden
Facility Name
Länssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
SE 55185
Country
Sweden
Facility Name
Länssjukhuset
City
Kalmar
ZIP/Postal Code
SE 39185
Country
Sweden
Facility Name
Universitetssjukhuset
City
Linköping
ZIP/Postal Code
SE 58185
Country
Sweden
Facility Name
Vrinnevisjukhuset
City
Norrköping
ZIP/Postal Code
SE 601 82
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
SE 17176
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
SE 75185
Country
Sweden
Facility Name
Värnamo sjukhus
City
Värnamo
ZIP/Postal Code
SE 33185
Country
Sweden
Facility Name
Centrallasarettet
City
Västerås
ZIP/Postal Code
SE 72189
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16671066
Citation
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.
Results Reference
background
PubMed Identifier
10560850
Citation
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.
Results Reference
background
PubMed Identifier
16035135
Citation
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.
Results Reference
background
PubMed Identifier
18662955
Citation
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.
Results Reference
background

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Treatment Strategies for Primarily Generalized Colorectal Cancer

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