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Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525785
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Stomach Cancer Gastric Cancer Drug: 5-Fluorouracil Drug: Folinic Acid Drug: Oxaliplatin Radiation: Radiotherapy Procedure: Surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2004
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5-Fluorouracil + Folinic Acid + Oxaliplatin

PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).

PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2/d Monday through Friday) & weekly oxaliplatin 45 mg/m^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).

Surgical resection 4-6 weeks after completion of chemoradiotherapy

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/m^2 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

Procedure: Surgery
4-6 weeks after completion of chemoradiotherapy, restaged & surgical resection of the primary tumor and lymph nodes attempted.




Primary Outcome Measures :
  1. Complete Pathologic Response Rate [ Time Frame: Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment ]

    The complete pathologic response (path CR) rate after 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.

    Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525785


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi-Synthelabo
Investigators
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Principal Investigator: Jaffer Ajani, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00525785    
Other Study ID Numbers: 2003-0769
NCI-2010-00749 ( Registry Identifier: NCI CTRP )
First Posted: September 6, 2007    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: January 2020
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:
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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
Leucovorin
Folic Acid
Fluorouracil
Oxaliplatin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients