Clinical trial NCT00718913: Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer
Official title: A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Adjuvant Gastric Cancer
Adjuvant chemotherapy
Adjuvant chemo-radiation
Capecitabine
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2008-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: The proportion of patients completing protocol therapy (feasibility)
timeFrame: The feasibility will be defined as the proportion of patients who receive adjuvant chemotherapy and chemo-radiation over total registered
Secondary outcomes:
measure: Toxicity profile
timeFrame: Toxicity assessment on each cycle
measure: Toxicity profile
timeFrame: Toxicity assessment on each chemotherapy cycle
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete Dept of Medical Oncology
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Larissa
country: Greece
facility: General Hospital of Larissa Dept of Medical Oncology
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Study officials:
affiliation: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
name: Ioannis Boukovinas, MD
role: PRINCIPAL_INVESTIGATOR
References: