NCT03251612

Brief Summary

The purpose of the present study is to investigate the benefit of anti-cancer therapy administered on the basis of drug sensitivity testing. This concerns colorectal cancer patients who have previously received standard treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2017

Typical duration for phase_2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

3.9 years

First QC Date

August 11, 2017

Last Update Submit

January 17, 2023

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

  • Progression free survival 8 weeks after start of treatment

    42-63 days after start of treatment

Secondary Outcomes (4)

  • Progression free survival

    Every 8 weeks until progression or death up to 2.5 years

  • Overall survival

    Every 3 months up to 2.5 years

  • Response rate

    Every 8 weeks until progression up to 2.5 years

  • Quality of life as measured by questionnaire EQ-5D-5L

    Every 8 weeks up to 2.5 years

Study Arms (1)

Treatment

OTHER

1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.

Drug: Based on sensitivity analysis

Interventions

Based on sensitivity analysisDRUG

* 5FU, infusional * Capecitabine * Oxaliplatin (FOLFOX) * Irinotecan (FOLFIRI) * FOLFOXIRI (triplet) * Bevacizumab * Panitumumab * Cetuximab * Regorafenib * Tas-102 * Ramucirumab * Aflibercept * Pembrolizumab * Nivolumab * Vinorelbine and capecitabine * Sorafenib * Gemcitabine and capecitabine * Olaparib * Epirubicin

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic colorectal cancer
  • Biopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis)
  • If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the colon or rectum (scanning or endoscopy)
  • Non-resectable metastatic spread
  • Previously exposed to or intolerance or contraindications to standard systemic therapy, defined as
  • oxaliplatin
  • irinotecan
  • fluorouracil (or similar such as capecitabine, S1)
  • VEGF inhibitor bevacizumab
  • EGFR inhibitor panitumumab or cetuximab (if RAS/RAF wt)
  • Progressive disease defined as progression according to RECIST 1.1
  • ECOG performance status 0-2
  • Age at least 18 years
  • Adequate bone marrow, liver and renal function allowing systemic chemotherapy
  • Absolute neutrophil count ≥1.5x10\^9/l and thrombocytes ≥ 100x10\^9/l.
  • +4 more criteria

You may not qualify if:

  • Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
  • Other active malignant disease requiring therapy
  • Other systemic anti-cancer therapy (palliative radiotherapy is allowed).
  • Pregnant (positive pregnancy test) or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Oncology, Aalborg University Hospital

Aalborg, Denmark

Location

Department of Oncology, Rigshospitalet

Copenhagen, Denmark

Location

Departmen of Oncology, Vejle Hospital

Vejle, Denmark

Location

Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)

Hamburg, Germany

Location

Related Publications (1)

  • Jensen LH, Rogatto SR, Lindebjerg J, Havelund B, Abildgaard C, do Canto LM, Vagn-Hansen C, Dam C, Rafaelsen S, Hansen TF. Precision medicine applied to metastatic colorectal cancer using tumor-derived organoids and in-vitro sensitivity testing: a phase 2, single-center, open-label, and non-comparative study. J Exp Clin Cancer Res. 2023 May 5;42(1):115. doi: 10.1186/s13046-023-02683-4.

    PMID: 37143108DERIVED

Study Officials

  • Lars H Jensen, MD

    Vejle Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 16, 2017

Study Start

September 22, 2017

Primary Completion

August 23, 2021

Study Completion

March 21, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

DE(1)DK(3)