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Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

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: NCT00655876
Recruitment Status : Active, not recruiting
First Posted : April 10, 2008
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Esophageal Cancer
Interventions: Drug: cetuximab
Drug: cisplatin
Drug: paclitaxel
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
No text entered.

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
Chemoradiation + Cetuximab External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
Chemoradiation External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin

Participant Flow:   Overall Study
    Chemoradiation + Cetuximab   Chemoradiation
STARTED   168   176 
COMPLETED   159 [1]   169 [1] 
NOT COMPLETED   9   7 
Protocol Violation                9                7 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  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 patients

Reporting Groups
  Description
Chemoradiation + Cetuximab External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
Chemoradiation External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Total Total of all reporting groups

Baseline Measures
   Chemoradiation + Cetuximab   Chemoradiation   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   169   328 
Age 
[Units: Years]
Median (Full Range)
 65 
 (39 to 87) 
 63 
 (32 to 85) 
 64 
 (32 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      29  18.2%      23  13.6%      52  15.9% 
Male      130  81.8%      146  86.4%      276  84.1% 


  Outcome Measures

1.  Primary:   Overall Survival (24-month Rate Reported)   [ Time Frame: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months. ]

2.  Secondary:   Local Failure (24-month Rate Reported)   [ Time Frame: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months. ]

3.  Secondary:   Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events   [ Time Frame: From start of treatment to 90 days from end of treatment ]

4.  Secondary:   Endoscopic Complete Response Rate   [ Time Frame: From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks) ]

5.  Secondary:   Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment   [ Time Frame: Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start. ]

6.  Secondary:   Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported   [ Time Frame: Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start. ]


  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
After a United Kingdom trial failed to show a benefit for cetuximab, accrual was suspended and the 3rd planned interim analysis done. After discussions with the Data Monitoring Committee, the study permanently closed to accrual on 2/8/2013.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00655876     History of Changes
Other Study ID Numbers: RTOG 0436
CDR0000538085
First Submitted: April 9, 2008
First Posted: April 10, 2008
Results First Submitted: December 20, 2017
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018