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A Randomised Phase Ii Study Of Pre-Operative Or Peri-Operative Docetaxel, Oxaliplatin, Capecitabine (Dox) Regimen In Patients With Locally Advanced Resectable Gastric Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

A Randomised Phase Ii Study Of Pre-Operative Or Peri-Operative Docetaxel, Oxaliplatin, Capecitabine (Dox) Regimen In Patients With Locally Advanced Resectable Gastric Cancer


Inclusion Criteria:



1. Signed written informed consents

2. Male or female 18-75 years of age

3. Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the
stomach

4. cT3 subserosal - cT4a - cT4b (7th edition UICC TNM) or bulky lymph node metastases
independently of T

5. ECOG performance status of 0-1 at study entry

6. Laboratory requirements (≤ 7 days prior chemotherapy start):

1. Hematology:

I) Neutrophils > 1.5 x 109 /L II) Platelets > 100 x 109 /L III) Hemoglobin >
10g/dL

2. Hepatic function I) Total bilirubin < 1.25 UNL II) AST (SGOT) and ALT (SGPT) <
2.5xUNL III) Alkaline phosphatase < 2.5xUNL

3. Renal function I) Creatinine <1.5 UNL In the event of border-line values, the
calculated creatinine clearance should be > 60 mL/min;

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

- Effective contraception for both male and female patients if the risk of
conception exists

Exclusion Criteria:

1. Early gastric cancer (if N0)

2. T2 (according to 7th edition of UICC TNM) if N0

3. Linitis plastica

4. Positive peritoneal cytology

5. Distant metastases

6. Neoplasm involving the gastro-esophageal junction

7. Pertoneal involvement

8. Concurrent chronic systemic immune therapy

9. Any investigational agent(s) administered 4 weeks prior to entry

10. Clinically relevant coronary artery disease, a history of myocardial infarction or of
hypertension not controlled by therapy within the last 12 months

11. Known grade 3 or 4 allergic reaction to any of the components of the treatment

12. Known drug abuse/alcohol abuse

13. Legal incapacity or limited legal capacity

14. Medical or psychological condition which, in the opinion of the investigator, would
not permit the patient to complete the study or sign meaningful informed consent

15. Women who are pregnant or breastfeeding

16. Acute or subacute intestinal occlusion

17. Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ
of the cervix. (Patients with a previous malignancy but without evidence of disease
for ≥ 5 years will be allowed to enter the trial)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

the difference in percentage of patients receiving all the planned chemotherapeutic cycles between the two arms.

Outcome Time Frame:

7 years

Safety Issue:

Yes

Authority:

Italy: Ethics Committee

Study ID:

IRST151.01

NCT ID:

NCT01876927

Start Date:

September 2010

Completion Date:

March 2017

Related Keywords:

  • Gastric Cancer
  • Locally
  • Advanced
  • Resectable
  • Gastric Cancer
  • Stomach Neoplasms

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