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Comparing HAI-90Y (SIR-spheres)+Chemotx LV5FU2 Versus Chemotx LV5FU2 Alone to Treat Colorectal Cancer

Information source: Universiteit Antwerpen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: HAI-90Y radioembolization (SIR-spheres injection) (Device); systemic chemotherapy LV5FU2 (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Universiteit Antwerpen

Official(s) and/or principal investigator(s):
Marc Peters, Study Chair, Affiliation: Universiteit Antwerpen
Marc Van den Eynde, Study Chair, Affiliation: University of St-Luc

Overall contact:
Nathalie Verbist, Phone: +32474074584, Email: nath.verbist@bgdo.org

Summary

The investigators propose to conduct a randomised phase III trial evaluating a maintenance strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus continuing simplified chemotherapy with/without targeted therapy versus continuing simplified chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.

Clinical Details

Official title: A Randomised Phase III Trial Comparing Hepatic Arterial Injection of Yttrium-90 Resin Microspheres (SIR-spheres) Plus Systemic Maintenance Therapy Versus Systemic Maintenance Therapy Alone for Patients With Unresectable Liver Metastases From Colorectal Cancer Which Are Controlled After Induction Systemic Therapy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to progression (TTP1 overall)

Secondary outcome:

Time to global progression (TTP1 + TTP2)

PFS

Safety

R0 resection rate

Quality of life

Overall Survival (OS)

Detailed description: The aim of the study is to investigate whether an intensified maintenance treatment of SIRT + simplified maintenance chemotherapy has a benefit in terms of time to progression (TTP) compared to simplified chemotherapy maintenance alone, in patients with stable disease after 3-6 months induction therapy. We would like to demonstrate the feasibility and safety of this approach and to investigate if this strategy has the potential to increase the outcome of the patient. Primary end-point:

- Time to first progression (TTP1 overall)

Secondary end-points:

- Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver

only

- Progression Free Survival (PFS)

- Safety

- Overall Survival (OS)

- Ro resection rate

- Quality of Life

Exploratory analysis:

- Prediction and evaluation of SIR-spheres treatment response (only for Belgian centres)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Willing and able to provide written informed consent 2. Histologically confirmed adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Unequivocal and measurable (RECIST 1. 1) CT evidence of liver metastases which are not treatable by surgical resection and/or local ablation with curative intent at the time of trial entry. 3. Partial response or stable disease (RECIST 1. 1 criteria, controlled metastatic disease) after chemotherapy induction with oxaliplatin and/or irinotecan based induction chemotherapy (doublet or triplet combinations) +/- targeted therapies during 3 to 6 months. 4. Trial inclusion must be performed between 3 and 6 months since the date of the first course of chemotherapy (induction) administration. 5. 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 individual nodule more than 1 cm in diameter or 1 single lesion of up to 1. 7 cm in diameter. Involvement of lymph nodes in 1 single anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm. 6. All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation. 7. Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. 8. 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 begin chemotherapy induction. Previous radiotherapy to the pelvis is not an exclusion criterion.

9. WHO performance status 0 - 1

10. Adequate hematological, renal and hepatic function as follows: Hematological Neutrophils > 1. 5 x 109/L Platelets > 100 x 109/L Renal Creatinine < 1. 5 x ULN (Upper Limit Normal) Hepatic Bilirubin ≤ 1. 0 X ULN Albumin ≥ 30g/L ALT ≤ 5. 0 x ULN AST ≤ 5. 0 x ULN LDH ≤ 2. 5 x ULN The date of blood tests must be within 28 days prior to the time of randomisation. 11. Age 18 years or older. 12. Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception. 13. Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception. 14. Life expectancy of at least 3 months without any active treatment. Exclusion criteria 1. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiological assessment. 2. More than 6 months since last chemotherapy administration before trial inclusion. 3. Previous radiotherapy delivered to the upper abdomen. 4. Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. 5. Prior major liver resection: remnant liver < 50% of the initial liver volume. Patient with a biliary stent can be included. 6. Liver tumor involvement > 80% before study inclusion (not at diagnosis but when trial inclusion for the patient is planned). 7. Resectable metastatic disease at trial inclusion. 8. Progressive disease during first-line metastatic chemotherapy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to start of 1st line chemotherapy. 9. No oxaliplatin or irinotecan use during the first 3 to 6 months induction chemotherapy. 10. Pregnant or breast feeding. 11. Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix. 12. Severe allergy to non-ionic contrast agents which would prevent contrast media use during the study.

Locations and Contacts

Nathalie Verbist, Phone: +32474074584, Email: nath.verbist@bgdo.org

ASZ Aalst, Aalst 9300, Belgium; Active, not recruiting

CUB Hôpital Erasme, Brussels 1070, Belgium; Active, not recruiting

Institut Jules Bordet, Brussels 1000, Belgium; Active, not recruiting

University of St-Luc, Brussels 1200, Belgium; Recruiting
Marc Van den Eynde, Principal Investigator

Grand Hôpital de Charleroi, Charleroi 6000, Belgium; Recruiting
Javier Carrasco, MD, Principal Investigator

ZOL Genk, Genk 3600, Belgium; Active, not recruiting

AZ St-Lucas Gent, Gent 9000, Belgium; Not yet recruiting
Monique Troch, MD

AZ Groeninge, Kortrijk 8500, Belgium; Recruiting
Philippe Vergauwe, MD

CHU de Liège, Liège 4000, Belgium; Recruiting
Marc Polus, MD, Principal Investigator

University of Antwerp, Edegem, Antwerp 2650, Belgium; Active, not recruiting

Additional Information

Starting date: August 2013
Last updated: June 8, 2015

Page last updated: August 20, 2015

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