Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

NCT00718913 | Completed Phase 2

• 1 other identifier: CT/08.07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

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.

Conditions

Gastric Cancer

Keywords

Adjuvant Gastric Cancer; Adjuvant chemotherapy; Adjuvant chemo-radiation; Capecitabine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Toxicity profile

  Toxicity assessment on each cycle

• Toxicity profile

  Toxicity assessment on each chemotherapy cycle

• Overall survival

  1 year

Study Arms (1)

1

EXPERIMENTAL

TCX -\>RT -\> TCX

Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine; Radiation: Radiation

Interventions

Docetaxel 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.

Also known as: Taxotere

1

Cisplatin 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.

Also known as: CDDP

1

Capecitabine 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).

Also known as: Xeloda

1

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.

Also known as: RT

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (8)

University Hospital of Crete Dept of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

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

Athens, Greece

Location

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

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

General Hospital of Larissa Dept of Medical Oncology

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Cisplatin; Capecitabine; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Physical Phenomena

Study Officials

• Ioannis Boukovinas, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

GR (8)