Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00938470
First received: July 10, 2009
Last updated: February 27, 2017
Last verified: February 2017
Results First Received: January 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer
Interventions: Drug: capecitabine
Drug: docetaxel
Drug: fluorouracil
Drug: oxaliplatin
Radiation: radiation therapy
Procedure: therapeutic conventional surgery

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Seventy-three participants were enrolled between January 2010 and July 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven participants from arm I were enrolled in the early toxicity evaluation portion. Additional sixty-six participants were randomized to arm I or II on the phase II portion of the study. There were 11 cancellations (5 arm I, 6 arm II) and these participants were excluded in all analyses.

Reporting Groups
  Description
Arm I (DOC, 5FU/O/RT, Surgery) Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
Arm II (5FU/O/RT, Surgery) Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.

Participant Flow:   Overall Study
    Arm I (DOC, 5FU/O/RT, Surgery)   Arm II (5FU/O/RT, Surgery)
STARTED   34   28 
COMPLETED   27   25 
NOT COMPLETED   7   3 
Disease Progression                3                0 
Alternate Treatment                1                0 
Death                3                2 
Other Reason                0                1 



  Baseline Characteristics
  Hide 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 randomized participants who initiated first cycle of protocol treatment.

Reporting Groups
  Description
Arm I (DOC, 5FU/O/RT, Surgery) Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
Arm II (5FU/O/RT, Surgery) Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
Total Total of all reporting groups

Baseline Measures
   Arm I (DOC, 5FU/O/RT, Surgery)   Arm II (5FU/O/RT, Surgery)   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   27   55 
Age 
[Units: Years]
Median (Full Range)
 62.5 
 (38 to 78) 
 65 
 (44 to 88) 
 63 
 (38 to 88) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  17.9%      4  14.8%      9  16.4% 
Male      23  82.1%      23  85.2%      46  83.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   28   27   55 
ECOG Performance Status 0-1 [1] 
[Units: Participants]
Count of Participants
 28   27   55 
[1]

Eastern Cooperative Oncology Group (ECOG) Performance Status:

0=Asymptomatic and fully active

1=Symptomatic and fully ambulatory

Tumor Stage [1] 
[Units: Participants]
Count of Participants
     
II      6  21.4%      9  33.3%      15  27.3% 
III      22  78.6%      18  66.7%      40  72.7% 
[1]

Staging group was defined by primary tumor (T), regional (N) and distant metastasis (M).

II= T2N0M0, T3N0M0 or T1-2, N1M0; III= T1-2,N2M0 or T3N1M0, T4aN0M0 or T3N2M0 or T4a,N1-2, M0 or T4b, Any N, M0 or Any T, N3, M0

M0=No M N0=No N M N1=M in 1-2 N N2=M in 3-6 N N3=M in >=7 N NX=N cannot be assessed (NA) T1=Invades lamina propria, muscularis mucosae, or submucosa T2=Invades muscularis propria T3=Invades adventitia T4=Invades adjacent structures T4a=Resectable T invading pleura, pericardium, or diaphragm T4b=Unresectable T invading other adjacent structures TX=T NA

Site of Tumor 
[Units: Participants]
Count of Participants
     
Esophagus      16  57.1%      11  40.7%      27  49.1% 
Gastroesophageal Junction      12  42.9%      14  51.9%      26  47.3% 
Gastric Cardia      0   0.0%      2   7.4%      2   3.6% 
Measurable Disease 
[Units: Participants]
Count of Participants
     
Yes      11  39.3%      11  40.7%      22  40.0% 
No      17  60.7%      16  59.3%      33  60.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Pathologic Complete Response (PCR)   [ Time Frame: Up to 2 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 2 years ]

3.  Secondary:   Disease-free Survival   [ Time Frame: Up to 2 years ]

4.  Secondary:   Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event   [ Time Frame: Up to 2 years ]

5.  Secondary:   Percentage of Participants With Overall Clinical Tumor Response (CR or PR)   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Steven R Alberts MD MPH
Organization: Mayo Clinic
phone: 507-284-4918
e-mail: alberts.steven@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00938470     History of Changes
Other Study ID Numbers: NCCTG-N0849
NCI-2011-01930 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000646724 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: July 10, 2009
Results First Received: January 3, 2017
Last Updated: February 27, 2017