Clinical trial NCT01056809: Treatment Strategies for Primarily Generalized Colorectal Cancer
Official title: Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Metastases
Treatment strategies
Colorectal cancer with synchronous metastases
Lead sponsor: Vrinnevi Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Council of Southeast Sweden
First posted: 2010-01-26
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: 3 years after completion of study
Secondary outcomes:
measure: 3 year survival for patients treated with curative intent
timeFrame: 3 years after randomization
measure: Palliative patients not receiving chemotherapy treated with the traditional strategy
timeFrame: Completion of study
measure: Quality of life
timeFrame: Every 6 months up to 3 years
measure: Health care consumption
timeFrame: Completion of study
measure: Complications and side effects
timeFrame: Completion of study
Other outcomes:
Locations:
city: Eksjö
country: Sweden
facility: Höglandssjukhuset
city: Gävle - Hudiksvall
country: Sweden
facility: Department of Surgery
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Kalmar
country: Sweden
facility: Länssjukhuset
city: Linköping
country: Sweden
facility: Universitetssjukhuset
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Värnamo
country: Sweden
facility: Värnamo sjukhus
city: Västerås
country: Sweden
facility: Centrallasarettet
Study officials:
affiliation: Department of Surgery in Östergötland
name: Gunnar Arbman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery in Östergötland
name: Per Sandström, MD, PhD
role: STUDY_CHAIR
affiliation: Regional Oncologic Center, Linköping
name: Hans Starkhammar, MD, PhD
role: STUDY_CHAIR
affiliation: University of Uppsala, The Karolinska University Hospital, Stockholm
name: Bengt Glimelius, Professor
role: STUDY_CHAIR
affiliation: The Karolinska University Hospital, Stockholm
name: Lars Lundell, Professor
role: STUDY_CHAIR
affiliation: The Karolinska Universtiy Hospital, Stockholm
name: Per-Olof Nyström, Professor
role: STUDY_CHAIR
affiliation: The Karolinska University hospital, Stockholm
name: Ulf Gunnarsson, Professor
role: STUDY_CHAIR
affiliation: Uppsala University
name: Lars Påhlman, Professor
role: STUDY_CHAIR
References:
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.
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.
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.
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.