Postoperative Chemotherapy and Chemo-Radiotherapy for Resected Gastric Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00718913

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer	Drug: Docetaxel Drug: Cisplatin Drug: Capecitabine Radiation: Radiation	Phase II

MedlinePlus related topics: Cancer Esophagus Disorders Radiation Therapy Stomach Cancer

Drug Information available for: Docetaxel Cisplatin Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	A Phase II Trial of Postoperative Chemotherapy and Chemo-Radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-Esophageal Junction

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity profile [ Time Frame: Toxicity assessment on each cycle ] [ Designated as safety issue: Yes ]
Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	49
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TCX ->RT -> TCX	Drug: 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. 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. 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). Radiation: 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. Drug: 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).

Arms

Assigned Interventions

1: Experimental

TCX ->RT -> TCX

Drug: 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.

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.

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).

Radiation: 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.

Drug: 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).

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718913

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Sofia Mavraki	+302810392987	maurakh@gmail.com

Locations

Greece
General Hospital of Larissa Dept of Medical Oncology	Recruiting
Larissa, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Athanasios Athanasiadis, MD
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Aris Polyzos, MD
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Recruiting
Piraeus, Greece
Contact: Nikoleta Karkatzou +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
401 Military Hospital of Athens	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalampos Christophillakis, MD
Air Forces Military Hospital of Athens	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
University General Hospital of Alexandroupolis, Dep of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr
Principal Investigator: Stelios Kakolyris, MD
Greece, Crete
University Hospital of Crete Dept of Medical Oncology	Recruiting
Heraklion, Crete, Greece
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr
Principal Investigator: Vassilis Georgoulias, MD

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:

Ioannis Boukovinas, MD

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

More Information

Responsible Party:	Hellenic Oncology Research Group ( A.Athanasiadis )
Study ID Numbers:	CT/08.07
Study First Received:	July 18, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00718913
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Adjuvant Gastric Cancer
Adjuvant chemotherapy
Adjuvant chemo-radiation
Capecitabine

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Stomach cancer
Docetaxel
Digestive System Diseases

Stomach Diseases
Cisplatin
Stomach Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2009