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PRE-OPERATIVE CHEMO-RADIOTHERAPIC TREATMENT IN ESOPHAGEAL AND GASTRO-ESOPHAGEAL JUNCTION ADENOCARCINOMA - ND

PRE-OPERATIVE CHEMO-RADIOTHERAPIC TREATMENT IN ESOPHAGEAL AND GASTRO-ESOPHAGEAL JUNCTION ADENOCARCINOMA - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011174-15-IT
Enrollment
Unknown
Registered
2009-03-17
Start date
2009-03-16
Completion date
Unknown
Last updated
2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESOPHAGEAL AND GASTRO-ESOPHAGEAL JUNCTION ADENOCARCINOMA MedDRA version: 9.1 Level: LLT Classification code 10061882 MedDRA version: 9.1 Level: PT Classification code 10030137 MedDRA version: 9.1 Level: LLT Classification code 10066350 MedDRA version: 9.1 Level: LLT Classification code 10061882

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: .5- Pharmac

Sponsors

AZIENDA OSPEDALIERA PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Adenocarcinoma esophagogastric junction histologically proven, II-III-M1 lymphnodal stadium; 2 Male or female, aged > 18 years and = 1,5 * 10^3μL; PLT >= 100 * 10^3 μL, Hg >=9 g/dl 6 Adequate hepatic function: bilirubin 1.5 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Prior adjuvant chemotherapy or radiotherapy; 2. Active uncontrolled infection; 3. Past or current history of neoplasm other than gastric carcinoma, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix; 4. Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia; 5. Patients with reproductive potential not implementing adequate contraceptive measures; 6 Pregnant or lactating patients; 7. Chronic obstructive pulmonary disease 8. Collagenopathy 9. History of significant psychiatric disorders 10. History of allergy to drugs (or their excipients) used in this study.

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the activity of chemoradiotherapy treatment in patients with esophageal and gastro-esophageal junction adenocarcinoma in terms of complete pathologic response rate.;Secondary Objective: 1 To evaluate the response rate in accord to RECIST criteria 2 To evaluate the feasibility and toxicity of treatment 3 To evaluate response rate in CT and PET scan 4 To investigate prediction of response in terms of: - SUV - Ki67 - p53 - GSTO 5 Progression-free survival and Overall survival;Primary end point(s): To evaluate percentage of pathological complete response rate.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026