E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced oesophago-gastric cancer which has previously been treated with a platinum and fluoropyrimidine based combination |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017758 |
E.1.2 | Term | Gastric cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001173 |
E.1.2 | Term | Adenocarcinoma of esophagus |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 assess whether chemotherapy with docetaxel improves survival in patients with advanced gastric cancer previously treated with platinum/fluoropyrimidine or raltitrexed therapy. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are quality of life, progression free survival and toxicity |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age >18 years -Histologically confirmed adenocarcinoma of the oesophagus or stomach (including adenocarcinoma of the oesophago-gastric junction) -Advanced disease not amenable to curative treatment -Documented progressive disease while receiving or within 6 months of completion of chemotherapy with a platinum and fluoropyrimidine or raltitrexed based therapy -Estimated life expectancy of at least 12 weeks -ECOG performance status 0,1 or 2 -Satisfactory hematological (Hb >10g/dL, WBC > 3.0 x 10 9/L, ANC > 1.5 x 10 9/L, Plt >100 x 10 9/L), renal (creatinine < ULN, or measured/calculated Creatinine clearance > 60ml/min) and hepatic (TBR < ULN, ALT < 1.5 x ULN, ALP < 5 x ULN) function -Ability to give informed consent -Completion of baseline QoL questionnaires (QLQ-C30,STO22 & EQ-5D) -Patients of both sexes with reproductive potential must employ barrier contraceptives whilst on treatment and for 3 months following completion of treatment |
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E.4 | Principal exclusion criteria |
-Cerebral or leptomeningeal metastasis -Prior chemotherapy with taxanes -Clinically significant peripheral neuropathy (Grade 2 to Grade 4) which in the view of the Investigator would be a contraindication to taxane therapy. -Previous malignancy within the 5 years prior trial entry except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia -Pregnant or lactating females |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 33 |
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 | Information not present in EudraCT |
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
|
Data will be analysed 6 months after recruitment of the final patient |
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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |