Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03251612 |
Recruitment Status :
Completed
First Posted : August 16, 2017
Last Update Posted : January 18, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer Metastatic | Drug: Based on sensitivity analysis | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer |
Actual Study Start Date : | September 22, 2017 |
Actual Primary Completion Date : | August 23, 2021 |
Actual Study Completion Date : | March 21, 2022 |
Arm | Intervention/treatment |
---|---|
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
|
- Progression free survival 8 weeks after start of treatment [ Time Frame: 42-63 days after start of treatment ]
- Progression free survival [ Time Frame: Every 8 weeks until progression or death up to 2.5 years ]
- Overall survival [ Time Frame: Every 3 months up to 2.5 years ]
- Response rate [ Time Frame: Every 8 weeks until progression up to 2.5 years ]
- Quality of life as measured by questionnaire EQ-5D-5L [ Time Frame: Every 8 weeks up to 2.5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251612
Denmark | |
Department of Oncology, Aalborg University Hospital | |
Aalborg, Denmark | |
Department of Oncology, Rigshospitalet | |
Copenhagen, Denmark | |
Departmen of Oncology, Vejle Hospital | |
Vejle, Denmark | |
Germany | |
Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH) | |
Hamburg, Germany |
Study Chair: | Lars H Jensen, MD | Vejle Hospital |
Responsible Party: | Vejle Hospital |
ClinicalTrials.gov Identifier: | NCT03251612 |
Other Study ID Numbers: |
Tumorspheres Colrec |
First Posted: | August 16, 2017 Key Record Dates |
Last Update Posted: | January 18, 2023 |
Last Verified: | January 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |