E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Resectable patients with locally advanced pancreatic disease treated with an innovative radio-chemotherapy scheme |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10015674 |
|
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 |
Step A: The primary objective is to evaluate the safety of the treatment. Step B: The primary objective is to evaluate the proportion of the resectable patients after radio-chemotherapy. |
|
E.2.2 | Secondary objectives of the trial |
Step A: Secondary objective is the control of IM (internal margin) intra-fraction. Step B: Secondary objectives are: overall survival (OS), local progression free survival (LPFS) and progression free survival (PFS). |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:1.0 Data:2010/08/02 Titolo:Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer. Obiettivi:Verify if the analysis of specific molecular markers, analysed in peripheral blood or in tumor tissue, can be able to predict the response to treatment, for a more personalized therapeutic approach. Moreover, the study aims also to evaluate the role of circulating molecular markers in monitoring the course of the disease.
|
|
E.3 | Principal inclusion criteria |
• Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer are candidates for the trial. • Stage III disease (AJCC TNM 6th edition, 2002). Inoperable disease, by radiological and surgical evaluation; • Age >18 years and ≤75 years. • Life expectancy of greater than 12 weeks. • ECOG performance status 0-2 (see Appendix A). • Presence of at least of one measurable lesion in agreement to RECIST criteria • Patients must have normal organ and marrow function as defined below: - Leukocytes >3,000/L - Absolute neutrophil count >1,500/L - Platelets >100,000/L - Total bilirubin < 1.5 X institutional upper limit of normal - AST (SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal (≤ 5 in patients with liver metastases) - Creatinine < 1.5 X institutional upper limit of normal • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • Ability to understand and the willingness to sign a written informed consent document. |
|
E.4 | Principal exclusion criteria |
• Patients who have had any chemotherapy or radiotherapy prior to entering the study; • Stage IV disease; • Participation in another clinical trial with any investigational agents within 30 days prior to study screening. • Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated >5 years before study entry. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and oxaliplatin or other agents used in the study. • Active brain or leptomeningeal disease • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Step A: The primary objective is to evaluate the safety of the treatment. Secondary objective is the control of IM (internal margin) intra-fraction. Step B: The primary objective is to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives are: overall survival (OS), local progression free survival (LPFS) and progression free survival (PFS). |
|
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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
| |
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |