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

Phase 2

Completed

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Based on sensitivity analysis

• Registration Number: NCT03251612
• Lead Sponsor: Vejle Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Study Start: 2017-09-22
• Primary Completion: 2021-08-23
• Study Completion: 2022-03-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Based on sensitivity analysis	1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.

Primary Outcome Measures

Name	Time	Method
Progression free survival 8 weeks after start of treatment	42-63 days after start of treatment

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by questionnaire EQ-5D-5L	Every 8 weeks up to 2.5 years
Progression free survival	Every 8 weeks until progression or death up to 2.5 years
Overall survival	Every 3 months up to 2.5 years
Response rate	Every 8 weeks until progression up to 2.5 years

Trial Locations

Locations (4)

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