Treatment Strategies for Primarily Generalized Colorectal Cancer

Colorectal Cancer Clinical Trial

— PGC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01056809
• Other study ID #: PGC-8
• Status: Terminated
• Phase: N/A
• First received: January 25, 2010
• Last updated: May 30, 2012
• Start date: January 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Vrinnevi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Chemotherapy and surgery
Treatment not specified but in accordance with national guidelines

Locations

Country	Name	City	State
Sweden	Höglandssjukhuset	Eksjö
Sweden	Department of Surgery	Gävle - Hudiksvall
Sweden	Länssjukhuset Ryhov	Jönköping
Sweden	Länssjukhuset	Kalmar
Sweden	Universitetssjukhuset	Linköping
Sweden	Vrinnevisjukhuset	Norrköping
Sweden	Karolinska Universitetssjukhuset	Stockholm
Sweden	Akademiska sjukhuset	Uppsala
Sweden	Värnamo sjukhus	Värnamo
Sweden	Centrallasarettet	Västerås

Sponsors (2)

Lead Sponsor	Collaborator
Vrinnevi Hospital	Medical Research Council of Southeast Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years after completion of study	No
Secondary	3 year survival for patients treated with curative intent		3 years after randomization	No
Secondary	Palliative patients not receiving chemotherapy treated with the traditional strategy		Completion of study	No
Secondary	Quality of life		Every 6 months up to 3 years	No
Secondary	Health care consumption		Completion of study	No
Secondary	Complications and side effects		Completion of study	Yes