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Open Label, Randomised, Multicenter Phase III Study of Adjuvant Chemotherapy in Radically Resected Adenocarcinoma of the Stomach or Gastroesophageal Junction: Comparison of a Sequential Treatment (CPT-11+5-FU/LV --> TXT+CDDP) Versus a 5-FU/LV Regimen


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Adenocarcinoma of the Stomach, Adenocarcinoma of the Gastroesophageal Junction

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Trial Information

Open Label, Randomised, Multicenter Phase III Study of Adjuvant Chemotherapy in Radically Resected Adenocarcinoma of the Stomach or Gastroesophageal Junction: Comparison of a Sequential Treatment (CPT-11+5-FU/LV --> TXT+CDDP) Versus a 5-FU/LV Regimen


Open label, randomised, multicenter, superiority study for efficacy. Patients with
histologically proven adenocarcinoma of the stomach or gastroesophageal junction without
gross or microscopic evidence of residual disease after surgery with curative intent and
fulfilling all the inclusion/exclusion criteria are eligible for this study.

Allocation to treatment will be done centrally using a randomisation scheme and will be
stratified by center and nodal involvement (N- vs. N+). Access to random system will be
allowed by phone or via web.

All included patients in both groups will received fixed period of 18 weeks of treatment
unless unacceptable toxicity or disease relapse during treatment. After cessation of
therapy, patients will have a follow-up period while not receiving further treatment. After
relapse further chemotherapy is left to the investigator's judgement. When the last patient
is randomised, follow-up will be truncated at the achievement of the required number of
events.

Time to progression and time to death are the main study outcomes. During the course of the
trial, an independent Data and Safety Monitoring Board (DSMB) will advise the Steering
Committee on efficacy and/or safety aspects of the study.


Inclusion Criteria:



- Histologically proven adenocarcinoma of the stomach or gastroesophageal junction
without gross or microscopic evidence of residual disease after surgery with curative
intent;

- Subtotal or total gastrectomy with at least D1 dissection;

- Gastroesophageal junction adenocarcinoma extending to the stomach with the center
lying 2 to 5 cm below the anatomic esophago-gastric junction;

- Patients with nodal involvement (pN+) or patients without nodal involvement (pN0)
with pT2b-3-4. It is recommended to examine at least 15 lymph nodes;

- Age between 18 and 75 years;

- ECOG performance status 0-1;

- No previous chemotherapy and/or radiotherapy;

- Complete staging procedures within 3 months prior to randomization;

- Laboratory requirement (within 8 days prior to randomization):

- Haematology (Neutrophils > 2.0 x 109 /L, Platelet > 100 x 109 /L, Hemoglobin >
10g/dL);

- Hepatic function (Total bilirubin < 1 UNL, ASAT (SGOT) and ALAT (SGPT) <
2.5xUNL, Alkaline phosphatase < 2.5xUNL. Patients with ASAT or ALAT > 1.5xUNL
associated with alkaline phosphatase > 2.5XUNL are not eligible.)

- Renal function (Creatinine < 1.5 UNL. In presence of borderline values, the
calculated creatinine clearance according to Cockroft-Gault formula, 60 ML/min.

- Recovery from acute effects of surgery. The first infusion of study chemotherapy
should be administered 3 to 8 weeks after surgery treatment;

- Written informed consent signed and dated before randomization procedures, including
expected cooperation of the patients for the treatment and follow-up, must be
obtained and documented according to the local regulatory requirement.

Exclusion Criteria:

- Non-radical surgery as assessed microscopically (no tumor-free margin of resection,
positive biopsy of peritoneal suspicious lesions);

- Synchronous metastases, even curatively resected;

- Pregnant or lactating patients; patients with reproductive potential must implement
adequate contraceptive measures;

- Prior or concurrent history of:

- positive HIV serology,

- chronic diarrhoea,

- chronic bowel inflammation or subobstruction,

- neoplasm other than gastric cancer, except for: curatively treated non-melanoma
skin cancer, in situ carcinoma of the cervix,

- previous history of myocardial infarction within 1 year from study entry,

- hypersensitivity reaction to polysorbate 80;

- Presence of other systemic disease limiting drug administration and influencing
patient survival:

- uncontrolled hypertension,

- high-risk uncontrolled arrhythmia,

- unstable angina pectoris;

- Symptomatic

- peripheral neuropathy,

- altered hearing > 2 grade by NCIC-CTG criteria;

- Active uncontrolled infection.

- Definite contra-indications for the use of corticosteroids: unstable diabetes
mellitus, active peptic ulcer;

- Concurrent administration of:

- corticosteroids or equivalent except as use for the prophylactic medication
regimen, treatment of acute hypersensitivity reactions or unless chronic
treatment (initiated > 6 months prior to study entry) at low doses (< 20mg
methylprednisolone or equivalent);

- any other experimental drug under investigation: concurrent treatment with any
other anticancer therapy, growth factors with preventive intent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival will be defined as the time from date of randomisation to date of first appearance of local, regional or distant relapse, or death from any cause; patients alive without relapse will be censored at date last known to be alive.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Emilio Bajetta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Nazionale Per lo Studio e la Cura dei Tumori Milano

Authority:

Italy: The Italian Medicines Agency

Study ID:

ITACA-S

NCT ID:

NCT01640782

Start Date:

February 2005

Completion Date:

December 2012

Related Keywords:

  • Adenocarcinoma of the Stomach
  • Adenocarcinoma of the Gastroesophageal Junction
  • adenocarcinoma of the stomach
  • adenocarcinoma of the gastroesophageal junction
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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