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Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00003298
Recruitment Status : Completed
First Posted : January 23, 2004
Results First Posted : June 23, 2015
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastric Cancer
Interventions: Drug: cisplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: paclitaxel
Procedure: surgery
Radiation: radiation therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
E7296 was activated on February 25, 1999 and terminated on March 18, 2002 with a final accrual of 39 patients (accrual goal: 42 patients) enrolled by 13 ECOG affiliated institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Experimental Arm Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.

Participant Flow for 4 periods

Period 1:   Step 1 (Neoadjuvant Therapy)
    Experimental Arm
STARTED   39 
Eligible and Treated   38 
Complete 3 Cycles of Neoadjuvant Therapy   35 
COMPLETED   35 
NOT COMPLETED   4 
Ineligible for step 1                1 
Adverse Event                3 

Period 2:   Surgery
    Experimental Arm
STARTED   35 
COMPLETED   28 [1] 
NOT COMPLETED   7 
Unresectable at surgery                3 
Progression before surgery                2 
Unevaluable and off study                2 
[1] 1 patient did not complete neoadjuvant therapy but went to surgery anyway, not included here.

Period 3:   Re-register to Step 2 After Surgery
    Experimental Arm
STARTED   28 
COMPLETED   10 
NOT COMPLETED   18 
Less than 15 nodes examined                7 
Positive margins                5 
Other complications                2 
Reason unknown                1 
Ineligible due to tumor staging                3 

Period 4:   Step 2 (Adjuvant Therapy)
    Experimental Arm
STARTED   10 
Eligible and Treated on Step 2   7 
COMPLETED   4 
NOT COMPLETED   6 
Ineligible                1 
Death                1 
Progression before starting treatment                1 
Excessive complication                1 
Withdrawal by Subject                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible and treated in step 1

Reporting Groups
  Description
Experimental Arm Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.

Baseline Measures
   Experimental Arm 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Years]
Median (Full Range)
 57 
 (34 to 78) 
Gender 
[Units: Participants]
 
Female   13 
Male   25 
Region of Enrollment 
[Units: Participants]
 
United States   38 


  Outcome Measures

1.  Primary:   Grade 3 or Higher Toxicity Incidence on Step 1   [ Time Frame: assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total) ]

2.  Secondary:   Best Confirmed Response to Neoadjuvant Therapy   [ Time Frame: Assessed at surgery time (surgery performed during week 8-10 after registration to the study) ]

3.  Secondary:   Overall Survival   [ Time Frame: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 ]

4.  Secondary:   Progression Free Survival   [ Time Frame: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012


Publications of Results:

Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00003298     History of Changes
Other Study ID Numbers: CDR0000066237
E7296 ( Other Identifier: Eastern Cooperative Oncology Group )
U10CA023318 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 1999
First Posted: January 23, 2004
Results First Submitted: June 2, 2015
Results First Posted: June 23, 2015
Last Update Posted: July 16, 2015