Metastatic Colorectal CancerNCT02597075
Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy
A study testing standard therapy + physical activity program and standard therapy in people with Metastatic Colorectal Cancer, run by Swiss Cancer Institute at 24 sites in 2 countries.
Trial summary
The purpose of this study is to assess whether a structured physical activity program (PA) during palliative chemotherapy improves progression-free survival (PFS) and/or patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- standard therapy + physical activity program and standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 17 Mar 2016to 30 Nov 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent according to ICH/GCP regulations before randomization.
- Patient with histologically or cytologically confirmed colorectal carcinoma (CRC) who start palliative first-line systemic therapy for inoperable or metastatic disease.
- Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.
- Patients with histologically or cytologically confirmed colorectal carcinoma (CRC), who start first-line "conversion"-therapy for borderline resectable metastatic disease and will be reassessed for metastasectomy after 3-4 months of systemic treatment.
- Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.
- Patients who are diagnosed with metastatic disease and were initially treated with surgery and/or radiochemotherapy to the primary tumor are eligible (except if all disease sites/metastases have been removed) Patients who have been curatively treated with histologically or cytologically confirmed nonmetastatic CRC previously and now relapse with metastatic disease are also eligible, irrespective of previous radiochemotherapy and/or adjuvant chemotherapy
Show all 11Show fewer
- Patients must have measurable disease on CT scan or MRI to be performed within 6 weeks before randomization (measurability criteria according to RECIST 1.1, non-nodal lesions ≥10 mm, lymph nodes ≥15mm) OR evaluable disease i.e. patient with nonmeasurable metastases but elevated serum tumor-marker (CEA at least >2xULN).
- Command of written and spoken language allowing for informed consent and for filling in trial questionnaires.
- Baseline patient-reported outcomes (PROs) have been completed.
- WHO performance status 0-2.
- Age ≥18 years
Who cannot join
- Pre-existing severe medical conditions precluding participation in a physical activity program as determined by the local investigator. Such conditions include: chronic heart failure (greater than NYHA II), recent myocardial infarction (less than 3 months ago), unstable angina pectoris, clinically significant arrhythmias, uncontrolled hypertension with repeated systolic blood pressure above 160mmHg, and COPD (requiring oxygen supply or GOLD stadium greater than 2).
- Inability to ride a cycle ergometer e.g. for musculoskeletal reasons.
- Patients in whom all CRC metastases have been removed surgically. It is allowed to include patients for whom metastasectomy might be an option if chemotherapy induces a significant response.
- Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes).
- Concurrent treatment in a trial with experimental drugs or other anti-cancer therapy, which are hypothesized to alter tumor progression. Participation in an observational trial or a translational trial is allowed. Palliative radiotherapy is allowed.
- Psychiatric disorder precluding understanding of trial information, giving informed consent, filling out PRO forms, or interfering with compliance.
- Any psychological, familial, sociological or geographical condition potentially hampering proper compliance with the trial protocol.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Switzerland22 sites
Tumor Zentrum Aarau
Aarau, CH-5000
Kantonsspital Aarau
Aarau, CH-5001
Kantonsspital Baden
Baden, 5404
St. Claraspital
Basel, CH-4016
Clinical Cancer Research Center at University Hospital Basel
Basel, CH-4031
Istituto Oncologico della Svizzera Italiana IOSI
Bellinzona, CH-6500
Spitalzentrum Biel
Biel, CH-2501
Spitalzentrum Oberwallis
Brig, 3900
Kantonsspital Graubünden
Chur, 7000
Hôpital Fribourgeois HFR
Fribourg, CH-1708
Hôpitaux Universitaires de Genève
Geneva, CH-1211
Centre de Chimiothérapie Anti-Cancéreuse
Lausanne, CH-1004
Kantonsspital Baselland
Liestal, CH-4410
Kantonsspital Luzern
Lucerne, 6000
Spital Thurgau
Münsterlingen, CH-8596
Kantonsspital Olten
Olten, CH-4600
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, 3600
Onkozentrum - Klinik im Park
Zurich, 8002
Onkozentrum Hirslanden Zürich
Zurich, CH-8032
Stadtspital Triemli
Zurich, CH-8063
UniversitätsSpital Zurich
Zurich, CH-8091
Austria2 sites
Universitätsklinikum der PMU Salzburg
Salzburg, r.greil@salk.at
Klinikum Wels-Grieskirchen GmbH
Wels, 4600
About this study
Official title: Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy. A Multicenter Open Label Randomized Controlled Trial
The purpose of this study is to assess whether a structured physical activity program (PA) during palliative chemotherapy improves progression-free survival (PFS) and/or patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.
Read the detailed description
While safety and feasibility as well as some improvements in fitness, fatigue and certain aspects of quality of life have been shown for physical activity in cancer patients during treatment, none of the pre-requisites above (i-iv) is fulfilled in the setting of patients with advanced colon cancer.
However, evidence, primarily from the adjuvant setting, that physical activity impacts on treatment tolerability and tumor progression is a strong enough rationale to now embark on this prospective trial. By assessing in a large randomized controlled trial whether a 12-week structured physical activity program during chemotherapy in patients with newly diagnosed colorectal cancer undergoing standard first-line chemotherapy improves progression-free survival as compared to standard first-line chemotherapy alone, all pre-requisites for a practice-changing intervention are met.
The physical exercise ACTIVE-program describes a 12-week exercise program consisting of a combination of a bi-weekly aerobic exercise (cycle ergometer) supervised by a physical therapist and a self-paced increase in physical activity during daily life using a pedometer with a daily step goal as a motivational tool.
In addition to the supervised exercise program twice a week, patients of the intervention group are recommended to be physically active at home.
All patients will undergo standard systemic therapy for metastatic colorectal cancer. Patients in the care-as-usual group are not actively encouraged to change their physical activity level e.g. to start a fitness program during chemotherapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- standard therapy + physical activity program, standard therapy
- Keywords
- Colorectal Cancer, Metastatic Colorectal Cancer, Physical Activity, Quality of life
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard therapy + physical activity programOther
standard therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Arm A: with ST + PA | Active comparator | Standard therapy + structured Physical activity and pedometer Receives: Other: standard therapy + physical activity program |
| Arm B: | Active comparator | Standard therapy Receives: Other: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Change between 2 tumor assessments
Measured: every 8 or 9 weeks during one year
Change in Patient-reported symptoms as measured by ESAS-r
The ESAS-r is a summary score ranging from 0 to 100 with lower scores representing better quality of life of the patients.
Measured: in at week 6, 12, 18, 24, 48
Secondary outcomes (5)
Overall survival
time from randomization to date of death. Patients without event at the time of analysis will be censored at the date they were last known to be alive.
Measured: after progression (expected 1 year) lifelong follow-up
Best Objective Response
best tumor response achieved during first-line systemic therapy according to RECIST criteria. Only remission status achieved during first-line therapy will be considered.
Measured: at week 8 or 9 during one year
Selected adverse events
assessed according to NCI CTCAE v4.0.
Measured: day 1 of each cycle (every 8 or 9 weeks)
Chemotherapy-completion-rate
total dose in mg which was applied divided by the total dose in mg which was initially planned according to the planned chemotherapy scheme. Absolute doses of chemotherapy agents applied will be collected after each chemotherapy cycle. The total planned dose will be derived based on the planned chemotherapy scheme which is specified at baseline incorporating weight or body surface.
The chemotherapy-completion-rate is defined as the number of dose modifications due to toxicity during the first 24 weeks after randomization per patient: after each 6 week-period (week 6, 12, 18, and 24) it is assessed whether there have been dose modifications (decrease/delay of systemic treatment i.e. chemo or biological) due to toxicity during the previous 6 weeks (y/n). The proportion of patients without any dose modification due to toxicity during the first 24 weeks will be calculated as well
Measured: week 6, 12, 18, and 24
Initiation or increase of anti-hypertensive drugs
In the subgroup of patients who receive bevacizumab. The proportion of patients receiving new or increased doses of anti-hypertensive drugs will be calculated.
Measured: day 1 of each cycle (every 8 or 9 weeks) for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start17 Mar 2016
- Primary completion21 Sep 2021
- Study completion30 Nov 2021
Why it stopped: Feasibility (low patient accrual and financial reasons)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viviane Hess, Prof Dr med, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597075
- Sponsor's protocol ID
- SAKK 41/14 - ACTIVE-2
- Other IDs
- 2015-003733-10, 2015-003733-10, 2015
- Status last verified
- Nov 2022
- First submitted
- 22 Oct 2015
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy. A Multicenter Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02597075
- Acronym / sponsor ID
- SAKK 41/14 - ACTIVE-2
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal Cancer, Metastatic Colorectal Cancer, Physical Activity, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility (low patient accrual and financial reasons)
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Nov 2015 (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.
The purpose of this study is to assess whether a structured physical activity program (PA) during palliative chemotherapy improves progression-free survival (PFS) and/or patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.
Detailed description
While safety and feasibility as well as some improvements in fitness, fatigue and certain aspects of quality of life have been shown for physical activity in cancer patients during treatment, none of the pre-requisites above (i-iv) is fulfilled in the setting of patients with advanced colon cancer.
However, evidence, primarily from the adjuvant setting, that physical activity impacts on treatment tolerability and tumor progression is a strong enough rationale to now embark on this prospective trial. By assessing in a large randomized controlled trial whether a 12-week structured physical activity program during chemotherapy in patients with newly diagnosed colorectal cancer undergoing standard first-line chemotherapy improves progression-free survival as compared to standard first-line chemotherapy alone, all pre-requisites for a practice-changing intervention are met.
The physical exercise ACTIVE-program describes a 12-week exercise program consisting of a combination of a bi-weekly aerobic exercise (cycle ergometer) supervised by a physical therapist and a self-paced increase in physical activity during daily life using a pedometer with a daily step goal as a motivational tool.
In addition to the supervised exercise program twice a week, patients of the intervention group are recommended to be physically active at home.
All patients will undergo standard systemic therapy for metastatic colorectal cancer. Patients in the care-as-usual group are not actively encouraged to change their physical activity level e.g. to start a fitness program during chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: with ST + PA | Active comparator | Other: standard therapy + physical activity programStandard therapy + structured Physical activity and pedometer |
| Arm B: | Active comparator | Other: standard therapyStandard therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent according to ICH/GCP regulations before randomization.
- Patient with histologically or cytologically confirmed colorectal carcinoma (CRC) who start palliative first-line systemic therapy for inoperable or metastatic disease.
- Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.
- Patients with histologically or cytologically confirmed colorectal carcinoma (CRC), who start first-line "conversion"-therapy for borderline resectable metastatic disease and will be reassessed for metastasectomy after 3-4 months of systemic treatment.
- Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.
Key exclusion criteria (7 listed)
- Pre-existing severe medical conditions precluding participation in a physical activity program as determined by the local investigator. Such conditions include: chronic heart failure (greater than NYHA II), recent myocardial infarction (less than 3 months ago), unstable angina pectoris, clinically significant arrhythmias, uncontrolled hypertension with repeated systolic blood pressure above 160mmHg, and COPD (requiring oxygen supply or GOLD stadium greater than 2).
- Inability to ride a cycle ergometer e.g. for musculoskeletal reasons.
- Patients in whom all CRC metastases have been removed surgically. It is allowed to include patients for whom metastasectomy might be an option if chemotherapy induces a significant response.
- Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes).
- Concurrent treatment in a trial with experimental drugs or other anti-cancer therapy, which are hypothesized to alter tumor progression. Participation in an observational trial or a translational trial is allowed. Palliative radiotherapy is allowed.
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 |
|---|---|---|
| standard therapy + physical activity program | Other | Arm A: with ST + PA |
| standard therapy | Other | Arm B: |
Primary outcome
Progression-free survival (PFS)
Time frame: every 8 or 9 weeks during one year
Change between 2 tumor assessments
Change in Patient-reported symptoms as measured by ESAS-r
Time frame: in at week 6, 12, 18, 24, 48
The ESAS-r is a summary score ranging from 0 to 100 with lower scores representing better quality of life of the patients.
5 secondary outcomes
Overall survival
Time frame: after progression (expected 1 year) lifelong follow-up
Best Objective Response
Time frame: at week 8 or 9 during one year
Selected adverse events
Time frame: day 1 of each cycle (every 8 or 9 weeks)
Chemotherapy-completion-rate
Time frame: week 6, 12, 18, and 24
Initiation or increase of anti-hypertensive drugs
Time frame: day 1 of each cycle (every 8 or 9 weeks) for one year
Results and safety
The study was stopped early (reason given: Feasibility (low patient accrual and financial reasons)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Viviane Hess, Prof Dr med study chair
University Hospital, Basel, Switzerland
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard therapy + physical activity program and standard therapy in people with Metastatic Colorectal Cancer, run by Swiss Cancer Institute at 24 sites in 2 countries.
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 11 inclusion and 7 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Switzerland, Austria. 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: Feasibility (low patient accrual and financial reasons)). 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?
Progression-free survival (PFS) (time frame: every 8 or 9 weeks during one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2022.