Clinical trial NCT03251612: Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
Official title: Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer Metastatic
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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
  * 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 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.
  * Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value
  * Calculated or measured renal glomerular filtration rate 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 contraceptive are acceptable
* Written and orally informed consent

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

Primary outcomes:
measure: Progression free survival 8 weeks after start of treatment
timeFrame: 42-63 days after start of treatment
Secondary outcomes:
measure: Progression free survival
timeFrame: Every 8 weeks until progression or death up to 2.5 years
measure: Overall survival
timeFrame: Every 3 months up to 2.5 years
measure: Response rate
timeFrame: Every 8 weeks until progression up to 2.5 years
measure: Quality of life as measured by questionnaire EQ-5D-5L
timeFrame: Every 8 weeks up to 2.5 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Oncology, Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
city: Vejle
country: Denmark
facility: Departmen of Oncology, Vejle Hospital
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)
Study officials:
affiliation: Vejle Hospital
name: Lars H Jensen, MD
role: STUDY_CHAIR
References: