Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and GEJ

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00525785
First received: September 4, 2007
Last updated: December 27, 2013
Last verified: December 2013
  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 2

Study Type: Interventional
Study Design: 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:


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

Primary Outcome Measures:
  • Complete Pathologic Response Rate [ Time Frame: 4-6 weeks after completion of chemoradiotherapy ] [ Designated as safety issue: No ]

    The complete pathologic response (path CR) rate after the treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate.

    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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-Fluorouracil + Folinic Acid + Oxaliplatin

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.

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

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.

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:

  1. 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).
  2. No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy.
  3. Patients must have a performance status of < 2 Zubrod scale.
  4. 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).
  5. Pretreatment evaluations must be done per the guidelines in Section 8.0.
  6. A feeding jejunostomy must be inserted in all patients.
  7. Patient must sign an informed consent prior to study entry.
  8. Patient must be chronologic <= 75.

Exclusion Criteria:

  1. Patients with T1N0 MO or T4 carcinoma documented by endoscopic ultrasonography.
  2. Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed by laparoscopy.
  3. Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes.
  4. Evidence of metastatic disease to distant organs (biopsy is suggested for questionable findings).
  5. Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.
  6. Patients with diabetic neuropathy.
  7. Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.
  8. Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin).
  9. Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 27, 2013
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
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Fluorouracil
Folic Acid
Levoleucovorin
Oxaliplatin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Substances
Hematinics
Hematologic Agents
Immunologic Factors
Immunosuppressive Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014