E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with histologically verified inoperable, locally advanced but non metastastic oesophageal cancer or cancer of cardia region (gastroesophageal junction) |
|
E.1.1.1 | Medical condition in easily understood language |
Esophagus cancer |
Spiserørskræft |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The study is designed to assess the efficacy of the addition of cetuximab to a chemoradiotherapy
regimen for the treatment of inoperable oesophageal/cardia cancer, in comparison to historical
experience with chemoradiotherapy alone
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E.2.2 | Secondary objectives of the trial |
To assess the safety profile of the addition of cetuximab to a chemoradiotherapy regimen for the
treatment of inoperable oesophageal/cardia cancer, additional efficacy assessment in terms of
relapse patterns and the longer term management of the patient. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically verified squamous cell carcinoma (including
basaloid-squamous cell and adenosquamous carcinoma) or
adenocarcinoma of the esophagus or the esophagogastric
junction (types I and II according to the Siewert
classification)
• Performance status (WHO) 0-2, age 18-80 y
• Locally advanced disease non-resectable (T4 N0-N3, M0) or disease which is not operable for any other reason (T2/T3 N0-N3, M0)
• Adequate hematological values: neutrophils ≥ 1.5 x 109/L,
platelets ≥ 100 x 109/L, Hb ≥9.0g/dL
- Adequate liver function:bilirubin ≤ 1.5 x ULN, AP ≤ 2.5 x
ULN, AST & ALT ≤ 1.5 x ULN
- Adequate renal function: GFR > 60 mL/min or Serum
creatinine: ≤ 100 mikromol/l
• Written informed consent
|
|
E.4 | Principal exclusion criteria |
• Distant metastases
• Prior chemotherapy or radiotherapy for oesophageal ca or ca of the cardia region
• Symptomatic peripheral neuropathy equal to or greater than NCI grade 2
• Other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed concent
• Severe or uncontrolled cardiovascular disease (congestive
heart failure NYHA III or IV), unstable angina pectoris,
history of myocardial infarction within the last 12 months,
significant arrhythmias)
Active uncontrolled infection
Serious underlying medical condition (judged by the
investigator) which could impair the ability of the patient to
participate in the trial (e.g. uncontrolled diabetes mellitus,
active autoimmune disease)
Concurrent treatment with other experimental drugs or other
anti-cancer therapy; treatment in a clinical trial within 30
days prior to trial entry
Definite contraindications for the use of corticosteroids and
antihistamines as premedication
Known hypersensitivity to trial drugs or hypersensitivity to
any other component of the trial drugs
Any concomitant drugs contraindicated for use with the trial
drugs according to the product information of the
pharmaceutical companies
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 5 years
• Pregnancy
- Breastfeeding women |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine local tumour control at 1 year
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Local tumor control at 1 year will be evaluated one year after the last patient has been included. |
|
E.5.2 | Secondary end point(s) |
Toxicity profile
Progression Free Survival
Pattern of relapse
Resectability Rate
Overall survival
Quality of Life |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Toxicity will be evaluated using NCI-CTCAE v 4.03 form inclusion in the trial until 30 days after last infusion of study drug.
Progression Free Survival: Patients will be followed with CT scans every 6 month.
The pattern of relapse will be recorded in CRF at relapse.
Quality of life will be evaluated baseline, visit 2, 4, 6 and 8. |
|
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) | 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
| 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |