E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
LUNG METASTASIS FROM COLON RECTAL CARCINOMA, SOFT TISSUE SARCOMA AND OSTEOSARCOMA |
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E.1.1.1 | Medical condition in easily understood language |
LUNG METASTASIS FROM COLON RECTAL CARCINOMA, SOFT TISSUE SARCOMA AND OSTEOSARCOMA |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with ILuP and pulmonary metastasectomy |
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E.2.2 | Secondary objectives of the trial |
TO DETERMINE THE TOXICITY OF MELPHALAN ON THE LUNG |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age of 18 years and older.
Patients with pulmonary metastases from colorectal carcinoma, sarcomas of soft tissue and osteosarcomas
Patients with pulmonary metastases from colorectal carcinoma, sarcomas of soft tissue and osteosarcomas
Cytologic/histologic proof or high clinical probability of pulmonary metastases of colorectal carcinoma, soft tissue sarcoma or osteosarcoma
No other systemic metastases present than pulmonary metastases
Primary site has been radically treated without signs of recurrence
Patient is a candidate for pulmonary metastasectomy with no more than 10 pulmonary metastases documented on CT scan of the thorax. Metastases must be located primarily in the periphery of the lungs.
No standard treatment options available, except pulmonary metastasectomy
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E.4 | Principal exclusion criteria |
Pregnancy/lactation
Uncontrollable infectious disease
Liver/renal insufficiency; serum creatinine more than 130 µmol/l and urine creatinine clearance less than 60 ml/min, ALAT and ASAT more than 3 times normal.
Severe comorbidity
Previous thoracotomy or pleuropulmonary diseases resulting in obliteration of the pleural space
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with ILuP and pulmonary metastasectomy |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
TO DETERMINE THE TOXICITY OF MELPHALAN ON THE LUNG |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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THE LAST VISIT OF THE LAST PATIENT ( DECEMBER 2014) WILL BE IN TWO YEARS FROM THE DATE OF THE OPERATION |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |