Predictive value of testing the sensitivity of anticancer treatment on tumorspheres from patients with metastatic colorectal cancer

Phase 1

• Conditions: MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000456-26-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-30
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

•Metastatic colorectal cancer
oBiopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis)
oIf 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)
oNon-resectable metastatic spread
•Exposed to or intolerance or contraindications to standard systemic therapy, defined as
ooxaliplatin
oirinotecan
o5-fluorouracil (or similar such as capecitabine, S1)
oVEGF inhibitor bevacizumab
oEGFR 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
oAbsolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/l.
oBilirubin = 1.5 x upper normal value and alanine aminotransferase = 3 x upper normal value
oCalculated 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified