Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

Treatments

Radiation: Radiation

Drug: Cisplatin

Drug: Capecitabine

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00718913

CT/08.07

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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