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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stomach Cancer
Gastric Cancer
Interventions Drug: 5-Fluorouracil
Drug: Folinic Acid
Drug: Oxaliplatin
Radiation: Radiotherapy
Procedure: Surgery
Enrollment 58
Recruitment Details Recruitment Period: January 13, 2004 to October 25, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title 5-Fluorouracil + Folinic Acid + Oxaliplatin
Hide Arm/Group Description

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

Period Title: Overall Study
Started 58
Completed 55
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Lack of Efficacy             1
Physician Decision             1
Arm/Group Title 5-Fluorouracil + Folinic Acid + Oxaliplatin
Hide Arm/Group Description FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid & infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2 for 5 days) & weekly oxaliplatin 45 mg/m^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy
Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 58 participants
55.5
(29.0 to 74.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
20
  34.5%
Male
38
  65.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Hispanic or Latino
10
  17.2%
Not Hispanic or Latino
48
  82.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
American Indian or Alaska Native
0
   0.0%
Asian
8
  13.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   8.6%
White
45
  77.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants
58
1.Primary Outcome
Title Complete Pathologic Response Rate
Hide Description

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.

Time Frame Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5-Fluorouracil + Folinic Acid + Oxaliplatin
Hide Arm/Group Description:
FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid & infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2 for 5 days) & weekly oxaliplatin 45 mg/m^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy.
Overall Number of Participants Analyzed 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14
(6 to 25)
Time Frame Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
Adverse Event Reporting Description Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
 
Arm/Group Title 5-Fluorouracil + Folinic Acid + Oxaliplatin
Hide Arm/Group Description

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

All-Cause Mortality
5-Fluorouracil + Folinic Acid + Oxaliplatin
Affected / at Risk (%)
Total   0/58 (0.00%)    
Hide Serious Adverse Events
5-Fluorouracil + Folinic Acid + Oxaliplatin
Affected / at Risk (%) # Events
Total   4/58 (6.90%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  1  1/58 (1.72%) 
Cardiac disorders   
Atrial Fibrillation  1  1/58 (1.72%) 
Gastrointestinal disorders   
Abdominal Pain  1  1/58 (1.72%)  1
Hemorrhage, GI-Stomach  1  4/58 (6.90%) 
Hyperbilrubinemia  1  1/58 (1.72%) 
Abdominal pain  1  1/58 (1.72%) 
Nausea Vomiting  1  2/58 (3.45%) 
Nausea  1  2/58 (3.45%) 
Vomiting  1  2/58 (3.45%) 
Diarrhea  1  1/58 (1.72%) 
Dehydration  1  3/58 (5.17%) 
GI Bleed  1  4/58 (6.90%) 
Jejunostomy tube placement (planned procedure)  1  1/58 (1.72%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5-Fluorouracil + Folinic Acid + Oxaliplatin
Affected / at Risk (%) # Events
Total   42/58 (72.41%)    
Blood and lymphatic system disorders   
Anemia  1  26/58 (44.83%) 
Thrombocytopenia  1  5/58 (8.62%) 
Leukopenia  1  14/58 (24.14%) 
Granulocytopenia  1  6/58 (10.34%) 
Increase ALT  1  6/58 (10.34%) 
Increase AST  1  7/58 (12.07%) 
Eye disorders   
Eyes red, Watery, Burning  1  14/58 (24.14%) 
Gastrointestinal disorders   
Nausea  1  40/58 (68.97%) 
Vomiting  1  16/58 (27.59%) 
Diarrhea  1  31/58 (53.45%) 
Constipation  1  18/58 (31.03%) 
Dysphagaia  1  20/58 (34.48%) 
Reflux GERD  1  25/58 (43.10%) 
Anorexia  1  42/58 (72.41%) 
Stomatitis  1  17/58 (29.31%) 
Abdominal pain  1  8/58 (13.79%) 
J-tube pain  1  7/58 (12.07%) 
General disorders   
Fatigue  1  42/58 (72.41%) 
Insomnia  1  29/58 (50.00%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  19/58 (32.76%) 
Back pain  1  6/58 (10.34%) 
Substernal chest pain  1  3/58 (5.17%) 
Nervous system disorders   
Neuropathy  1  36/58 (62.07%) 
Dizziness  1  11/58 (18.97%) 
Headache  1  8/58 (13.79%) 
Respiratory, thoracic and mediastinal disorders   
Hiccups  1  10/58 (17.24%) 
Skin and subcutaneous tissue disorders   
Skin Rash  1  12/58 (20.69%) 
Alopecia  1  5/58 (8.62%) 
Hand, Foot, Skin  1  3/58 (5.17%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jaffer Ajani, MD / Professor, GI Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2828
EMail: jajani@mdanderson.org
Layout table for additonal information
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 Submitted: September 4, 2007
First Posted: September 6, 2007
Results First Submitted: January 29, 2020
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020