ClinicalTrials.gg
CompletedNCT03251612Updated Jan 18, 2023

Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer

A Phase 2 interventional study of Based on sensitivity analysis in Colorectal Cancer Metastatic, sponsored by Vejle Hospital. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Vejle Hospital · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 17 studies in Colorectal Neoplasms by Vejle Hospital — 5 open to participants now, 6 under way, none of them phase 3. Colorectal Neoplasms · Vejle Hospital.

Enrollment
5th of 14
90 · median 77
Started
2017
the only one that year
Phase 2
8 of 17
1 open now
Registered
10th of 17
by date

Among the 17 studies in Colorectal Neoplasms by Vejle Hospital, this one is the 5th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2017, is one of 8 in phase 2, and was the 10th registered.

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

5 of the 17 studies in Colorectal Neoplasms by Vejle Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Colorectal Cancer Metastatic
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • colorectal cancer

    • 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 to standard systemic therapy, defined as

    • oxaliplatin
    • irinotecan
    • 5-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 1.1
  • performance status 0-2
  • Age at least 18 years
  • Adequate bone marrow, liver and renal function allowing systemic chemotherapy

    • ≥1.5x10\^9/l and ≥ 100x10\^9/l.
    • ≤ 1.5 x upper normal value and ≤ 3 x upper normal value
    • Calculated or measured renal at least 30 mL/min
  • Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal are acceptable
  • Written and orally

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Other
    Treatment

    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

  • DrugBased on sensitivity analysis

    * 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

This study also gives Pembrolizumab, Nivolumab, Olaparib. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Progression free survival 8 weeks after start of treatment

    Time frame: 42-63 days after start of treatment

Secondary outcomes

  1. Progression free survival

    Time frame: Every 8 weeks until progression or death up to 2.5 years

  2. Overall survival

    Time frame: Every 3 months up to 2.5 years

  3. Response rate

    Time frame: Every 8 weeks until progression up to 2.5 years

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

    Time frame: Every 8 weeks up to 2.5 years

07

Study locations

4 sites
  • Department of Oncology, Aalborg University Hospital
    Aalborg, Denmark
  • Department of Oncology, Rigshospitalet
    Copenhagen, Denmark
  • Departmen of Oncology, Vejle Hospital
    Vejle, Denmark
  • Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)
    Hamburg, Germany
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Aug 2021, 47 months.

Of 498 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 75. This study's 47 months is below that.

Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2017
First posted
Aug 16, 2017
StartActual
Sep 22, 2017
Primary completionActual
Aug 23, 2021
CompletionActual
Mar 21, 2022
Last update
Jan 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03251612
Lead sponsor
Vejle Hospital
Responsible party
Sponsor
First posted
Aug 16, 2017
Start date
Sep 22, 2017
Primary completion
Aug 23, 2021
Completion
Mar 21, 2022
Last update
Jan 18, 2023

Study contacts

Lars H Jensen, MD
study chair · Vejle Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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