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

Primary Purpose

Colorectal Cancer Metastatic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Based on sensitivity analysis

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Oncology, Aalborg University Hospital
Department of Oncology, Rigshospitalet
Departmen of Oncology, Vejle Hospital
Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival 8 weeks after start of treatment

Secondary Outcome Measures

Progression free survival

Overall survival

Response rate

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

Full Information

NCT ID

NCT03251612

First Posted

August 11, 2017

Last Updated

January 17, 2023

Sponsor

Vejle Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03251612

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

September 22, 2017 (Actual)

Primary Completion Date

August 23, 2021 (Actual)

Study Completion Date

March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vejle Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Based on sensitivity analysis

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival 8 weeks after start of treatment

Time Frame

42-63 days after start of treatment

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

Every 8 weeks until progression or death up to 2.5 years

Title

Overall survival

Time Frame

Every 3 months up to 2.5 years

Title

Response rate

Time Frame

Every 8 weeks until progression up to 2.5 years

Title

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

Time Frame

Every 8 weeks up to 2.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars H Jensen, MD

Organizational Affiliation

Vejle Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Oncology, Aalborg University Hospital

City

Aalborg

Country

Denmark

Facility Name

Department of Oncology, Rigshospitalet

City

Copenhagen

Country

Denmark

Facility Name

Departmen of Oncology, Vejle Hospital

City

Vejle

Country

Denmark

Facility Name

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

City

Hamburg

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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