Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

NCT ID: NCT00718913

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-09-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

TCX -\>RT -\> TCX

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel will be given at 60 mg/m2, as a 60-minute infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Docetaxel 60 mg/m2.

Cisplatin

Intervention Type: DRUG

Cisplatin will be given at 60 mg/m2, as 2-hour infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Cisplatin at 60 mg/m2.

Capecitabine

Intervention Type: DRUG

Capecitabine will be given orally at 1800 mg/m2 days 1 through 14 divided in two daily doses before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Capecitabine at 1800 mg/m2 days 1 through 14 (divided in two daily doses).

Radiation

Intervention Type: RADIATION

At the end of the second cycle of chemotherapy and one week of rest (day 27), a total of 45 Gy (1.8 Gy fx/d) of radiotherapy will be given.

Capecitabine

Intervention Type: DRUG

Capecitabine will be administered orally during radiotherapy for radiosensitization(1650 mg/m2 per day divided in two daily doses, 5 days/week, on Monday through Friday).

Interventions

Docetaxel

Docetaxel will be given at 60 mg/m2, as a 60-minute infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Docetaxel 60 mg/m2.

Intervention Type: DRUG

Cisplatin

Cisplatin will be given at 60 mg/m2, as 2-hour infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Cisplatin at 60 mg/m2.

Intervention Type: DRUG

Capecitabine

Capecitabine will be given orally at 1800 mg/m2 days 1 through 14 divided in two daily doses before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Capecitabine at 1800 mg/m2 days 1 through 14 (divided in two daily doses).

Intervention Type: DRUG

Radiation

At the end of the second cycle of chemotherapy and one week of rest (day 27), a total of 45 Gy (1.8 Gy fx/d) of radiotherapy will be given.

Intervention Type: RADIATION

Capecitabine

Capecitabine will be administered orally during radiotherapy for radiosensitization(1650 mg/m2 per day divided in two daily doses, 5 days/week, on Monday through Friday).

Intervention Type: DRUG

Other Intervention Names

Taxotere; CDDP; Xeloda; RT; Xeloda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ioannis Boukovinas, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University Hospital of Crete Dept of Medical Oncology

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, , Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, , Greece

401 Military Hospital of Athens

Athens, , Greece

Air Forces Military Hospital of Athens

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

Countries

Greece

Other Identifiers

CT/08.07

Identifier Type: -

Identifier Source: org_study_id