Clinical trial · Interventional
Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
NCT02748811CI-TRIAL-00040850GERICOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail, elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive geriatric assessment and intervention before and during treatment with chemotherapy. The hypotheses are: Optimizing the health conditions and functional status of frail elderly patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will lead to a higher grade of completing the planned chemotherapy and at higher dose intensity. This will also result in a higher overall survival and improve quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- The control group receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change in treatment or progression. If the patient has other health problems, those issues will be assessed either by the oncologist or by the general practitioner. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
- type
- ACTIVE_COMPARATOR
- label
- Intervention group
- description
- The intervention group also receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change of treatment or progression. They will simultaneously receive full geriatric assessement and intervention. The clinical examination includes laboratory parameters, review of medication list, psycho-cognitive assessement, screening for malnutrition and need of physiotherapy, optimizing social support. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
- interventionNames
- Other: Intervention group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Frail according to the screening tool G8 ( ≤14 / 17points) * Performance status 0-2 and life expectancy ≥ 3 months * Patients who have undergone surgery for stage III / high-risk stage II colorectal cancer or patients with unresectable or metastatic disease * Are assessed to receive adjuvant chemotherapy or first -line chemotherapy * Meets the criteria to receive preventive chemotherapy with 5-FU or capecitabine +/- oxaliplatin or first -line chemotherapy with 5-FU / irinotecan and / or oxaliplatin , capecitabine +/- possibly with the addition of immunotherapy in the form of cetuximab , panitumumab or bevacizumab. * Informed written and oral consent Exclusion Criteria: * Other malignancy except basal cell carcinoma and squamous cell carcinoma in situ cervicis uteri in 5 years * Patients in simultaneously drug trials * The patient must not have previously received adjuvant chemotherapy in the GERICO Protocol
References
Publications (2)
- DERIVEDLund CM, Vistisen KK, Olsen AP, Bardal P, Schultz M, Dolin TG, Ronholt F, Johansen JS, Nielsen DL. The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO). Br J Cancer. 2021 Jun;124(12):1949-1958. doi: 10.1038/s41416-021-01367-0. Epub 2021 Apr 7. PMID 33828260
- DERIVEDLund CM, Vistisen KK, Dehlendorff C, Ronholt F, Johansen JS, Nielsen DL. The effect of geriatric intervention in frail elderly patients receiving chemotherapy for colorectal cancer: a randomized trial (GERICO). BMC Cancer. 2017 Jun 28;17(1):448. doi: 10.1186/s12885-017-3445-8. PMID 28659138