Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00069953
First received: October 3, 2003
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: October 14, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Esophageal Cancer
Interventions: Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy

  Participant Flow
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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
ChemoRT and Selective Surgery Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.

Participant Flow:   Overall Study
    ChemoRT and Selective Surgery  
STARTED     43  
COMPLETED     41 [1]
NOT COMPLETED     2  
Protocol Violation                 2  
[1] Subjects with data available for the primary analysis are considered to have completed the study



  Baseline Characteristics
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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.
All eligible patients.

Reporting Groups
  Description
ChemoRT and Selective Surgery Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.

Baseline Measures
    ChemoRT and Selective Surgery  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 42 to 81 )  
Gender  
[units: participants]
 
Female     7  
Male     34  



  Outcome Measures

1.  Primary:   Overall Survival (1-year Rate Reported)   [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ]

2.  Secondary:   Frequency of Major (Grade 4) Acute Treatment-related Toxicities   [ Time Frame: From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery). ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection   [ Time Frame: Analysis occurs with the primary outcome measure. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:
Swisher S, Winters K, Komaki R, et al.: A phase II study of a paclitaxel based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-190, S106, 2007.


Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00069953     History of Changes
Other Study ID Numbers: RTOG-0246, CDR0000306455
Study First Received: October 3, 2003
Results First Received: October 14, 2014
Last Updated: October 14, 2014
Health Authority: United States: Federal Government