Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine; Radiation: Radiation

• Registration Number: NCT00718913
• Lead Sponsor: Hellenic Oncology Research Group

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	TCX -\>RT -\> TCX
1	Radiation	TCX -\>RT -\> TCX
1	Cisplatin	TCX -\>RT -\> TCX
1	Capecitabine	TCX -\>RT -\> TCX

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Toxicity profile	Toxicity assessment on each chemotherapy cycle
Overall survival	1 year

Trial Locations

Locations (8)

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

University Hospital of Crete Dept of Medical Oncology; 🇬🇷 Heraklion, Crete, Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

General Hospital of Larissa Dept of Medical Oncology; 🇬🇷 Larissa, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, Greece