E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colorectal cancer with recurrent liver metastases |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027457 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the safety of Litx therapy and the efficacy of Litx
+chemotherapy versus chemotherapy alone in treating patients with recurrent
liver metastases from colorectal cancer as determined by progression free
survival (PFS). |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate the safety of Litx therapy and the efficacy of Litx
+chemotherapy versus chemotherapy alone in treating patients with recurrent
liver metastases from colorectal cancer as determined by overall survival |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients with recurrent metastatic liver lesions from colorectal
cancer who progressed on either FOLFOX or FOLFIRI
2. Biopsy proven evidence of colorectal cancer
3. At least one liver lesion that can be measured in one dimension at
>10 mm with spiral CT scan (CT preferred but MRI allowed)
4. ECOG Performance Status 0-2
5. Life expectancy of at least 16 weeks
6. At least 30 days must have elapsed since the completion of any
prior antineoplastic therapy and the patient must have recovered
from acute side effects
7. Understanding and ability to sign written informed consent
8. 18 years of age or more
9. Adequate hematologic, liver and renal functions |
|
E.4 | Principal exclusion criteria |
1. Patients who are candidates for complete surgical resection
2. Patients received bevacuzimab (Avastin) or cetuximab (Erbitux)
within 30 days of randomization. Use of bevacuzimab or cetuximab
is prohibited while participating in this study
3. Patients with more than 6 lesions in the liver
4. Patients whose lesions would not be covered by planned ablation by
up to three LitxTM treatments with up to 4 light sources per
treatment
5. Patients whose measurable tumor sum of the longest diameters
(SLD) exceeds 7.5 cm
6. Target lesions irradiated within 3 months of randomization
7. Patients with tumor involvement in greater than 50% of
parenchyma
8. Evidence of major vessel invasion or extrahepatic metastases.
Lymph node involvement in the hilum region of the liver is eligible
if the nodes do not exceed 2 cm.
9. Patient with any non-colorectal cancers except for adequately
treated basal or squamous cell skin cancer, or adequately treated
stage I or II cancer from which the patient has been disease-free for
> 3 years, or other cancer from which the patient has been diseasefree
for > 5 years.
10. Known sensitivity to porphyrin-type drugs or known history of
porphyria
11. Pregnancy or breast-feeding patients. A negative pregnancy test
(urine or serum) from women of childbearing age is required prior
to enrollment. A fertile patient must use effective contraception
during participation in the study
12. Concurrent participation in another clinical trial involving
experimental treatment.
13. Any concurrent disease or condition that in the opinion of the
investigator impairs the patients ability to complete the trial such
as psychological, familial, sociological, geographical or medical
conditions which in the Principal Investigators opinion could
compromise compliance with the objectives and procedures of this
protocol or obscure interpretation of the trials data. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |