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Treatment Strategies for Primarily Generalized Colorectal Cancer

NCT ID: NCT01056809

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Keywords

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Colorectal cancer Metastases Treatment strategies Colorectal cancer with synchronous metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional strategy

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

Group Type ACTIVE_COMPARATOR

Chemotherapy and surgery

Intervention Type PROCEDURE

Treatment not specified but in accordance with national guidelines

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

Group Type ACTIVE_COMPARATOR

Chemotherapy and surgery

Intervention Type PROCEDURE

Treatment not specified but in accordance with national guidelines

Interventions

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Chemotherapy and surgery

Treatment not specified but in accordance with national guidelines

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council of Southeast Sweden

OTHER_GOV

Sponsor Role collaborator

Vrinnevi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gunnar Arbman

Consultant surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Arbman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery in Östergötland

Per Sandström, MD, PhD

Role: STUDY_CHAIR

Department of Surgery in Östergötland

Hans Starkhammar, MD, PhD

Role: STUDY_CHAIR

Regional Oncologic Center, Linköping

Bengt Glimelius, Professor

Role: STUDY_CHAIR

University of Uppsala, The Karolinska University Hospital, Stockholm

Lars Lundell, Professor

Role: STUDY_CHAIR

The Karolinska University Hospital, Stockholm

Per-Olof Nyström, Professor

Role: STUDY_CHAIR

The Karolinska Universtiy Hospital, Stockholm

Ulf Gunnarsson, Professor

Role: STUDY_CHAIR

The Karolinska University hospital, Stockholm

Lars Påhlman, Professor

Role: STUDY_CHAIR

Uppsala University

Locations

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Höglandssjukhuset

Eksjö, , Sweden

Site Status

Department of Surgery

Gävle - Hudiksvall, , Sweden

Site Status

Länssjukhuset Ryhov

Jönköping, , Sweden

Site Status

Länssjukhuset

Kalmar, , Sweden

Site Status

Universitetssjukhuset

Linköping, , Sweden

Site Status

Vrinnevisjukhuset

Norrköping, , Sweden

Site Status

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Site Status

Akademiska sjukhuset

Uppsala, , Sweden

Site Status

Värnamo sjukhus

Värnamo, , Sweden

Site Status

Centrallasarettet

Västerås, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 16671066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10560850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16035135 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18662955 (View on PubMed)

Other Identifiers

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PGC-8

Identifier Type: -

Identifier Source: org_study_id