Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy

NCT02597075 | Terminated

• 2 other identifiers: SAKK 41/14 - ACTIVE-22015-003733-10
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 24

Brief 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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal Cancer; Metastatic Colorectal Cancer; Physical Activity; Quality of life

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  Change between 2 tumor assessments

  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.

  in at week 6, 12, 18, 24, 48

Secondary Outcomes (5)

• Overall survival

  after progression (expected 1 year) lifelong follow-up

• Best Objective Response

  at week 8 or 9 during one year

• Selected adverse events

  day 1 of each cycle (every 8 or 9 weeks)

• Chemotherapy-completion-rate

  week 6, 12, 18, and 24

• Initiation or increase of anti-hypertensive drugs

  day 1 of each cycle (every 8 or 9 weeks) for one year

Study Arms (2)

Arm A: with ST + PA

ACTIVE COMPARATOR

Standard therapy + structured Physical activity and pedometer

Other: standard therapy + physical activity program

Arm B:

ACTIVE COMPARATOR

Standard therapy

Other: standard therapy

Interventions

standard therapy + physical activity program OTHER

Arm A: with ST + PA

standard therapy OTHER

Arm B:

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (24)

Universitätsklinikum der PMU Salzburg

Salzburg, r.greil@salk.at, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

Tumor Zentrum Aarau

Aarau, CH-5000, Switzerland

Location

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

St. Claraspital

Basel, CH-4016, Switzerland

Location

Clinical Cancer Research Center at University Hospital Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana IOSI

Bellinzona, CH-6500, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Spitalzentrum Oberwallis

Brig, 3900, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Hôpital Fribourgeois HFR

Fribourg, CH-1708, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, CH-1211, Switzerland

Location

Centre de Chimiothérapie Anti-Cancéreuse

Lausanne, CH-1004, Switzerland

Location

Kantonsspital Baselland

Liestal, CH-4410, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Spital Thurgau

Münsterlingen, CH-8596, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

SpitalSTS AG Simmental-Thun-Saanenland

Thun, 3600, Switzerland

Location

Onkozentrum - Klinik im Park

Zurich, 8002, Switzerland

Location

Onkozentrum Hirslanden Zürich

Zurich, CH-8032, Switzerland

Location

Stadtspital Triemli

Zurich, CH-8063, Switzerland

Location

UniversitätsSpital Zurich

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Viviane Hess, Prof Dr med

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: November 4, 2015
• Study Start: March 17, 2016
• Primary Completion: September 21, 2021
• Study Completion: November 30, 2021
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CH (22)