Colorectal CancerPGCNCT01056809
Treatment Strategies for Primarily Generalized Colorectal Cancer
A study testing Chemotherapy and surgery in people with Colorectal Cancer, run by Vrinnevi Hospital at 10 sites in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Chemotherapy and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesSweden
- Study dates
- Jan 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Sweden10 sites
Höglandssjukhuset
Eksjö, SE 57581
Department of Surgery
Gävle - Hudiksvall
Länssjukhuset Ryhov
Jönköping, SE 55185
Länssjukhuset
Kalmar, SE 39185
Universitetssjukhuset
Linköping, SE 58185
Vrinnevisjukhuset
Norrköping, SE 601 82
Karolinska Universitetssjukhuset
Stockholm, SE 17176
Akademiska sjukhuset
Uppsala, SE 75185
Värnamo sjukhus
Värnamo, SE 33185
Centrallasarettet
Västerås, SE 72189
About this study
Official title: Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Chemotherapy and surgery
- Keywords
- Colorectal cancer, Metastases, Treatment strategies, Colorectal cancer with synchronous metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy and surgeryProcedure or surgery
Treatment not specified but in accordance with national guidelines
| Study group | Role | What they receive |
|---|---|---|
| Traditional strategy | Active comparator | First resection of the primary colorectal tumour, then treatment of metastases with chemotherapy and if possible surgery. Receives: Procedure: Chemotherapy and 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 Receives: Procedure: Chemotherapy and surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years after completion of study
Secondary outcomes (5)
3 year survival for patients treated with curative intent
Measured: 3 years after randomization
Palliative patients not receiving chemotherapy treated with the traditional strategy
Measured: Completion of study
Quality of life
Measured: Every 6 months up to 3 years
Health care consumption
Measured: Completion of study
Complications and side effects
Measured: Completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Too slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrinnevi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden
- Responsible party
- Principal investigator, Gunnar Arbman, Vrinnevi Hospital
- Investigators
- Gunnar Arbman, MD, PhD, Principal investigator, Department of Surgery in ÖstergötlandPer Sandström, MD, PhD, Study chair, Department of Surgery in ÖstergötlandHans Starkhammar, MD, PhD, Study chair, Regional Oncologic Center, LinköpingBengt Glimelius, Professor, Study chair, University of Uppsala, The Karolinska University Hospital, StockholmLars Lundell, Professor, Study chair, The Karolinska University Hospital, StockholmPer-Olof Nyström, Professor, Study chair, The Karolinska Universtiy Hospital, StockholmUlf Gunnarsson, Professor, Study chair, The Karolinska University hospital, StockholmLars Påhlman, Professor, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056809
- Sponsor's protocol ID
- PGC-8
- Acronym
- PGC
- Status last verified
- May 2012
- First submitted
- 25 Jan 2010
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16671066Scoggins 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.
PubMed 10560850Benoist 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.
PubMed 16035135Scheer 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.
PubMed 18662955
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies
- ClinicalTrials.gov ID
- NCT01056809
- Acronym / sponsor ID
- PGC / PGC-8
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Metastases, Treatment strategies, Colorectal cancer with synchronous metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vrinnevi HospitalUniversity, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional strategy | Active comparator | Procedure: Chemotherapy and surgeryFirst resection of the primary colorectal tumour, then treatment of metastases with chemotherapy and if possible surgery. |
| Alternative strategy | Active comparator | Procedure: Chemotherapy and surgeryFirst 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy and surgeryTreatment not specified but in accordance with national guidelines | Procedure or surgery | Alternative strategy, Traditional strategy |
Primary outcome
Overall survival
Time frame: 3 years after completion of study
5 secondary outcomes
3 year survival for patients treated with curative intent
Time frame: 3 years after randomization
Palliative patients not receiving chemotherapy treated with the traditional strategy
Time frame: Completion of study
Quality of life
Time frame: Every 6 months up to 3 years
Health care consumption
Time frame: Completion of study
Complications and side effects
Time frame: Completion of study
Results and safety
The study was stopped early (reason given: Too slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
- Background: PubMed 16671066Mentha 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.
- Background: PubMed 10560850Scoggins 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.
- Background: PubMed 16035135Benoist 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.
- Background: PubMed 18662955Scheer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Arbman, MD, PhD principal investigator
Department of Surgery in Östergötland
Per Sandström, MD, PhD study chair
Department of Surgery in Östergötland
Hans Starkhammar, MD, PhD study chair
Regional Oncologic Center, Linköping
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy and surgery in people with Colorectal Cancer, run by Vrinnevi Hospital at 10 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years after completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056809, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.