Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718913
• Other study ID #: CT/08.07
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2008
• Last updated: May 14, 2015
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: May 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
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	University Hospital of Crete Dept of Medical Oncology	Heraklion	Crete
Greece	General Hospital of Larissa Dept of Medical Oncology	Larissa
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Piraeus

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Toxicity profile		Toxicity assessment on each cycle	Yes
Secondary	Toxicity profile		Toxicity assessment on each chemotherapy cycle	Yes
Secondary	Overall survival		1 year	No