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A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction

Phase 2
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction

Patients with localized gastric cancer often relapse either locally or systemically. A
strategy to reduce relapses at common sites would be beneficial. Our prior trial has proved
the feasibility of administering FOLFIRI regimen as adjuvant chemotherapy combined with
adjuvant chemoradiation in patients with excised with curative intend gastric cancer. It
would be important to improve the treatment involving active regimen as adjuvant
chemotherapy and optimizing chemoradiation by introducing capecitabine as a radiosensitizer.

Inclusion Criteria:

- Patients with radically resected adenocarcinoma of the stomach and/or
gastroesophageal junction with histologic proof of adenocarcinoma, pathologically
staged T2-3, any N, M0

- No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any

- Patients must have a life expectancy of at least 16 weeks and a performance status of
< 2 ECOG scale

- Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based
regimen. Patients who relapse within the first 6 months after the completion of
adjuvant treatment are not eligible for the study.

- Patients must have adequate bone marrow function (defined as peripheral absolute
granulocyte count of > 2.000/µL, and platelet count of > 100.000/µL), adequate liver
function (bilirubin < 1,5 mg/dl), and adequate renal function (creatinine < 1,5 mg/dl

- Patients must be able to understand the nature of this study and give written
informed consent

Exclusion Criteria:

- Patients with T1N0 carcinoma

- Positive cytology of pleural, or pericardial effusion or patients with any peritoneal
disease diagnosed intra-operatively)

- Biopsy proof of lymph node metastases outside the study field such as
supraclavicular, mediastinal, or para-aortic nodes

- Evidence of metastatic disease to distant organs

- Patients with cardiac disease graded as New York Heart Association Class III or IV,
severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection

- Patients with diabetic neuropathy

- Abnormalities of mental status such that either the patient cannot fully comprehend
the therapeutic implications of the protocol or comply with the requirements

- Presence of concurrent or previous malignancies in the past 5 years (except for
resected squamous or basal cell carcinoma of the skin)

- Pregnant women are excluded from study entry due to the teratogenic effects of the
study treatment

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients completing protocol therapy (feasibility)

Outcome Time Frame:

The feasibility will be defined as the proportion of patients who receive adjuvant chemotherapy and chemo-radiation over total registered

Safety Issue:


Principal Investigator

Ioannis Boukovinas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology


Greece: National Organization of Medicines

Study ID:




Start Date:

June 2008

Completion Date:

June 2010

Related Keywords:

  • Gastric Cancer
  • Adjuvant Gastric Cancer
  • Adjuvant chemotherapy
  • Adjuvant chemo-radiation
  • Capecitabine
  • Stomach Neoplasms