Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT00718913
• Date of registration: 18/07/2008
• Prospective Registration: No
• Primary sponsor: Hellenic Oncology Research Group
• Public title: Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer
• Scientific title: A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction
• Date of first enrolment: April 2008
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00718913
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Greece

Contacts

• Name: Ioannis Boukovinas, MD
• Affiliation: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Key inclusion & exclusion criteria

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
reason

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Gastric Cancer

Intervention(s)

Drug: Docetaxel

Drug: Capecitabine

Radiation: Radiation

Drug: Cisplatin

Primary Outcome(s)

The proportion of patients completing protocol therapy (feasibility) [Time Frame: The feasibility will be defined as the proportion of patients who receive adjuvant chemotherapy and chemo-radiation over total registered]

Secondary Outcome(s)

Toxicity profile [Time Frame: Toxicity assessment on each chemotherapy cycle]

Toxicity profile [Time Frame: Toxicity assessment on each cycle]

Overall survival [Time Frame: 1 year]

Secondary ID(s)

CT/08.07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of Crete