Randomised comparative study of folfox6m plus SIR-Spheres microspheres versus folfox6m alone as first line treatment in patients with non-resectable liver metastases from primary colorectal carcinoma

• Register: EUCTR
• Last refreshed on: 13 February 2017
• Main ID: EUCTR2008-003737-25-DE
• Date of registration: 01/10/2008
• Prospective Registration: Yes
• Primary sponsor: Sirtex Technology Pty Ltd
• Public title: Randomised comparative study of folfox6m plus SIR-Spheres microspheres versus folfox6m alone as first line treatment in patients with non-resectable liver metastases from primary colorectal carcinoma
• Scientific title: Randomised comparative study of folfox6m plus SIR-Spheres microspheres versus folfox6m alone as first line treatment in patients with non-resectable liver metastases from primary colorectal carcinoma - SIRFLOX
• Date of first enrolment: 26/11/2008
• Target sample size: 570
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003737-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Spain, United States

Contacts

• Name: Dir.Clin.Affair.EU,Midd.East,Africa
• Affiliation: Sirtex Technology Germany GmbH

• Name: Dir.Clin.Affair.EU,Midd.East,Africa
• Affiliation: Sirtex Technology Germany GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Willing and able to provide written informed consent.
- Histologically confirmed adenocarcinoma of the colon or rectum,with or without primary tumour in situ
- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of trial entry
- Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or 1 lesion of up to 1.7cm in diameter. Involvement of lymph nodes in 1 anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm.
- Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator.
- All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation
- Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to entry into this study. Radiotherapy to the pelvis is not an exclusion criterion
- WHO performance status 0 - 1
- Adequate haematological, renal and hepatic function as follows:
Haematological: Neutrophils >1.5 x 10^9/L
Platelets >100 x 10^9/L
Renal: Creatinine <1.5 x ULN
Hepatic: Billirubin <=30 µmol/L
Albumin >=30 g/L
The date of blood tests must be within 28 days prior to the time of randomisation
- Aged 18 years or older.
- Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
- Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
- Life expectancy of at least 3 months without any active treatment.


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 443
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 127

Exclusion criteria:
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
- Previous radiotherapy delivered to the upper abdomen.
- Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
- Peripheral neuropathy > grade 1 (NCI-CTCv3).
- Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy.
- Previous chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before the documentation of metastatic disease.
- Pregnant or breast feeding.
- Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix.
- Allergy to non-ionic contrast agents



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non-resectable liver metastasis from primary colorectal carcinoma
MedDRA version: 17.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Eloxatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Oxaliplatin
CAS Number: 63121-00-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: 5-fluorouracil
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 5-fluorouracil
CAS Number: 51-21-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: leucovorin
Product Name: folinic acid
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: folinic acid
CAS Number: 1492-18-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: Progression free survival in the liver
Overall survival
Tumour response rate (liver ± any site)
Hepatic and extra-hepatic recurrence rate
Quality of life
Toxicity and Safety
Liver resection rate

Primary end point(s): The primary outcome of this study is progression free survival.
Progression-free survival (PFS) is defined as the time interval between randomisation and the date of tumour progression. Tumour progression in the liver is determined from serial CT scans. Diagnosis of tumour recurrence (progression of disease) should be made by using RECIST Criteria.
The documented date of recurrence will be the date of confirmation of the recurrence. At the time of recurrence, the investigator should clearly indicate the site of tumour recurrence (hepatic or extra-hepatic).

Main Objective: The primary outcome of this study is progression free survival.

Timepoint(s) of evaluation of this end point: End of Trial

Secondary Outcome(s)

Secondary end point(s): Patients will be followed until death and treatment arms compared by assessment of:
Progression free survival in the liver
Overall survival
Tumour response rate (liver ± any site)
Hepatic and extra-hepatic recurrence rate
Quality of life
Liver resection rate
Toxicity and safety

Timepoint(s) of evaluation of this end point: End of Trial

Secondary ID(s)

STX0206-SIRFLOXstudy

Source(s) of Monetary Support

Sirtex Technology Pty Ltd