Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and GEJ - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Sanofi-Synthelabo
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00525785

Purpose

The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or gastroesophageal cancers that will be removed by surgery if possible. The safety of this combination therapy will also be studied.

Condition	Intervention	Phase
Stomach Cancer Gastric Cancer	Drug: 5-Fluorouracil Drug: Folinic Acid Drug: Oxaliplatin Radiation: Radiotherapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Fluorouracil Leucovorin Folic acid Citrovorum factor Oxaliplatin Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Pathologic response rate [ Time Frame: 4-6 weeks after completion of chemoradiotherapy ] [ Designated as safety issue: Yes ]
Follow up 3, 6, 9, and 12 months after surgery and every 6 months until Year 3, then once a year til Year 5.

Estimated Enrollment:	58
Study Start Date:	January 2004
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 5-Fluorouracil + Folinic Acid + Oxaliplatin	Drug: 5-Fluorouracil 2.2 Gm/m^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump. Other Names: 5-FU Adrucil Efudex Drug: Folinic Acid 200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43. Drug: Oxaliplatin 100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 45 mg/m2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week). Other Name: Eloxatin Radiation: Radiotherapy 45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days. Other Name: XRT

Arms

Assigned Interventions

Experimental: 5-Fluorouracil + Folinic Acid + Oxaliplatin

Drug: 5-Fluorouracil

2.2 Gm/m^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43.

Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump.

Other Names:

5-FU
Adrucil
Efudex

Drug: Folinic Acid

200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.

Drug: Oxaliplatin

100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43.

Chemoradiotherapy: 45 mg/m2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week).

Other Name: Eloxatin

Radiation: Radiotherapy

45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.

Other Name: XRT

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with potentially resectable adenocarcinoma of the stomach with histologic proof of adenocarcinoma, clinically staged T2-3, any N, M0 or T1N1M0 Gastric carcinoma may involve the gastroesophageal junction, however, the bulk of the tumor must be in the stomach (defined by radiographs, endoscopy, or endoscopic ultrasonography).
No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy.
Patients must have a performance status of < 2 Zubrod scale (Appendix II).
Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of >1,500/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).
Pretreatment evaluations must be done per the guidelines in Section 8.0.
A feeding jejunostomy must be inserted in all patients.
Patient must sign an informed consent prior to study entry.
Pt must be chronologic <= 75.

Exclusion Criteria:

Patients with T1N0 MO or T4 carcinoma documented by endoscopic ultrasonography.
Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed by laparoscopy.
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 (biopsy is suggested for questionable findings).
Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebrovascular 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 potential teratogenic effects of the study treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525785

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Sanofi-Synthelabo

Investigators

Principal Investigator:

Jaffer Ajani, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00525785 History of Changes
Other Study ID Numbers:	2003-0769
Study First Received:	September 4, 2007
Last Updated:	December 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Stomach Cancer
Gastric Cancer
Adenocarcinoma of the Stomach
Gastroesophageal Junction
Esophageal
Gastric
5-Fluorouracil
5-FU
Adrucil

Efudex
Folinic Acid
Oxaliplatin
Eloxatin
Chemoradiotherapy
Radiation
Radiotherapy
XRT

Additional relevant MeSH terms:

Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Oxaliplatin
Leucovorin

Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012