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NCT Number: NCT00718913

Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Crete Dept of Medical Oncology, Heraklion, Crete, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Taxotere

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.

Other names: CDDP

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).

Other names: Xeloda

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.

Other names: RT

Primary outcomes

  1. 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

Secondary outcomes

  1. Toxicity profile

    Time frame: Toxicity assessment on each cycle

  2. Toxicity profile

    Time frame: Toxicity assessment on each chemotherapy cycle

  3. Overall survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study title

A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 21, 2008
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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