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| Name | Class |
|---|---|
| Medical Research Council of Southeast Sweden | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional strategy | Active Comparator | First resection of the primary colorectal tumour, then treatment of metastases with chemotherapy and if possible 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy and surgery | Procedure | Treatment not specified but in accordance with national guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years after completion of study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Höglandssjukhuset | Eksjö | SE 57581 | Sweden | |||
| Department of Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16671066 | Background | 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. | |
| 10560850 | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Quality of life |
| Every 6 months up to 3 years |
| Health care consumption | Completion of study |
| Complications and side effects | Completion of study |
| Gävle - Hudiksvall |
| Sweden |
| Länssjukhuset Ryhov | Jönköping | SE 55185 | Sweden |
| Länssjukhuset | Kalmar | SE 39185 | Sweden |
| Universitetssjukhuset | Linköping | SE 58185 | Sweden |
| Vrinnevisjukhuset | Norrköping | SE 601 82 | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | SE 17176 | Sweden |
| Akademiska sjukhuset | Uppsala | SE 75185 | Sweden |
| Värnamo sjukhus | Värnamo | SE 33185 | Sweden |
| Centrallasarettet | Västerås | SE 72189 | Sweden |
| 16035135 | 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. |
| 18662955 | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |