E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with recurrent liver metastases from colorectal cancer who have progressed on either FOLFOX4 or FOLFIRI |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050035 |
E.1.2 | Term | Metastatic colon cancer |
|
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 (LS11 + light source) 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1/ Patients with recurrent 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; 4/ 18 years of age or more 5/ Adequate hematologic, liver and renal function as defined in the protocol |
|
E.4 | Principal exclusion criteria |
1/ Patients who are candidates for complete surgical resection; 2/ Patients who would require more than a total number of 12 light sources; 3/ Patients who have a single measurable tumor greater than 7,5cm in the longest diameter 4/ known sensitivity to porphyrin-type drugs or known history of porphyria; 5/pregnancy or breast-feeding patients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
progression free survival (PFS) |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 |
Litx therapy (Light Infusion Therapy) and chemotherapy vs chemotherapy alone |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | Yes |
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
|
All patients will be monitored for survival from time of last randomization until death from any cause or 180 weeks, whichever occurs first. Once the patient has confirmed progressive disease or reached 128 weeks, no more visits are required. The patient will be followed for survival by phone and/or email at 12-week intervals. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |