Study with sequence of chemiotherapeutic agents in patients with locally advanced inoperable or metastatic gastric or esophageal cancer

RANDOMIZED PHASE II STUDY WITH SEQUENTIAL NON-CROSS RESISTANT CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE OR METASTATIC GASTRO-ESOPHAGEAL ADENOCARCINOMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003039-20-IT

Enrollment

150

Registered

2014-09-30

Start date

2014-11-28

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Locally advanced inoperable or metastatic gastro-esophageal adenocarcinoma MedDRA version: 17.0 Level: PT Classification code 10030144 Term: Oesophageal adenocarcinoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: PT Classification code 10001150 Term: Adenocarcinoma gastric System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: PT

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DOCETAXEL CAS Number: 114977-28-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologic diagnosis for gastric or esophageal adenocarcinoma, stage III inoperable or IV; 2. Age > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: 1. Over-expression (+++) of HER2 receptor (by ICH) or HER2 gene amplification (by FISH) in positive cases ++ at ICH; 2. Cerebral metastases not controlled by any therapy; 3. Previous (less than 10 years) or concomitant malignant neoplasm execpt for in situ carcinoma of the cervix, squamous carcinoma and skin basal cell carcinoma, if not resolved; 4) Congestive heart failure (Class III and IV, New York Heart Association [NYHA]), angina pectoris not controlled by therapy or myocardial infarction within 6 weeks prior to enrollment; 5) Clinically significant cardiovascular disease (included myocardial infarction, unstable angina, heart failure, serious arrhythmia not controlled by therapy) within the last 12 months prior to enrollment; 6) Abnormal hematologic and biochemical parameters: • Alkaline phosphatase >/= 2.5 X ULN • Total bilirubin >/= 1.5 x ULN • AST/ALT >/= 2.5 x UNL unless liver metastasis >/= 5 UNL • creatinine >/= 1.5 x UNL and/or creatinine clearance < 60 ml/min • Neutrophils <1500/mm3, platelets <100.000/mm3, hemoglobin <10 g/dl 7) Pregnant or breastfeeding women, or pregnancy planned within 6 months from the end of treatment; 8) Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 9) Deficiency of DPD; 10) Previous hypersensitivity to any of the IMP.

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify the most efficacious sequence of chemiotherapeutic agents in terms of progression free survival between mDCF for 4 cycles followed by mDCF or by COFFI until progression in patients with gastric or esophageal adenocarcinoma. ;Secondary Objective: - To evaluate the efficacy of the chemotherapeutic agents sequences based on tumor objective response; - To evaluate the overall survival; - To assess overall tolerability and safety; - To evaluate the effect of treatments on the quality of life of patients. ;Primary end point(s): Progression Free Survival - PFS;Timepoint(s) of evaluation of this end point: From randomization date until desease progression at the following assessment points: at the end of induction period, every 8 weeks during treatment, at the end of treatment and every 8 weeks during follow up.	—

Measure

Time frame

Main Objective: To identify the most efficacious sequence of chemiotherapeutic agents in terms of progression free survival between mDCF for 4 cycles followed by mDCF or by COFFI until progression in patients with gastric or esophageal adenocarcinoma. ;Secondary Objective: - To evaluate the efficacy of the chemotherapeutic agents sequences based on tumor objective response; - To evaluate the overall survival; - To assess overall tolerability and safety; - To evaluate the effect of treatments on the quality of life of patients. ;Primary end point(s): Progression Free Survival - PFS;Timepoint(s) of evaluation of this end point: From randomization date until desease progression at the following assessment points: at the end of induction period, every 8 weeks during treatment, at the end of treatment and every 8 weeks during follow up.

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Overall Response Rate – ORR; 2) Time To Progression - TTP 3) Overall Survival - OS; 4) Safety profile assessed on the base of laboratory and clinic parameters (hematology, biochemistry, ECOG-PS) and on the evaluation of Adverse Events classified per type, frequency, seriousness (NCI, Common Terminology Criteria, Version 4.0 – CTCAE v.4.0), releted to study therapy, duration; 5) Quality of life evaluated through EORTC QLQ-C30 questionnaire. ;Timepoint(s) of evaluation of this end point: 1-2) From randomization date until desease progression at the following assessment points: at the end of induction period, every 8 weeks during treatment, at the end of treatment and every 8 weeks during follow up; 3) from randomization date to patient’s death for any cause or last date documenting the patient is alive, until 18 months from the date of evaluation of treatment end; 4)-5) All study period including follow up.	—

Measure

Time frame

Secondary end point(s): 1) Overall Response Rate – ORR; 2) Time To Progression - TTP 3) Overall Survival - OS; 4) Safety profile assessed on the base of laboratory and clinic parameters (hematology, biochemistry, ECOG-PS) and on the evaluation of Adverse Events classified per type, frequency, seriousness (NCI, Common Terminology Criteria, Version 4.0 – CTCAE v.4.0), releted to study therapy, duration; 5) Quality of life evaluated through EORTC QLQ-C30 questionnaire. ;Timepoint(s) of evaluation of this end point: 1-2) From randomization date until desease progression at the following assessment points: at the end of induction period, every 8 weeks during treatment, at the end of treatment and every 8 weeks during follow up; 3) from randomization date to patient’s death for any cause or last date documenting the patient is alive, until 18 months from the date of evaluation of treatment end; 4)-5) All study period including follow up.

—

Countries

Italy

Contacts

Public ContactS.C. Oncologia Medica

A.O. Istituti Ospitalieri di Cremona

g.tomasello@ospedale.cremona.it+390372405248

Outcome results

None listed

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