Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00089544
First received: August 6, 2004
Last updated: May 29, 2014
Last verified: January 2013
Results First Received: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Adult Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Interventions: Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: dacarbazine
Biological: filgrastim
Radiation: radiation therapy
Drug: thalidomide
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis

  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
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
Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
Cohort B (Thalidomide, Radiation, Surgery) Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.

Participant Flow:   Overall Study
    Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)     Cohort B (Thalidomide, Radiation, Surgery)  
STARTED     16     7  
COMPLETED     15 [1]   7  
NOT COMPLETED     1     0  
Ineligible                 1                 0  
[1] Subjects contributing data to the primary analysis are considered to have completed the study.



  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.
All eligible patients who started treatment.

Reporting Groups
  Description
Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
Cohort B (Thalidomide, Radiation, Surgery) Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)     Cohort B (Thalidomide, Radiation, Surgery)     Total  
Number of Participants  
[units: participants]
  15     7     22  
Age  
[units: years]
Median ( Full Range )
  49.0  
  ( 20.0 to 75.0 )  
  47.0  
  ( 39.0 to 81.0 )  
  48  
  ( 20 to 81 )  
Gender  
[units: participants]
     
Female     7     2     9  
Male     8     5     13  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation   [ Time Frame: Duration of treatment (which can continue up to approximately 15 months). ]

2.  Secondary:   Wound Complication (Grades 2, 3, 4, and 5) as Measured by CTCAE v3.0   [ Time Frame: From start of treatment to time of surgery ]

3.  Secondary:   Response to Pre-operative Therapy Assessed Using RECIST Criteria   [ Time Frame: From start of treatment to time of surgery. ]


  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
This study closed early due to unacceptably high rate of thromboembolic events in Cohort A and due to low accrual in Cohort B. For this reason efficacy endpoints other than response to pre-operative therapy were not reported.


  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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: wseiferheld@acr.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00089544     History of Changes
Other Study ID Numbers: NCI-2012-02588, NCI-2012-02588, CDR0000365499, RTOG-0330, RTOG-0330, U10CA021661
Study First Received: August 6, 2004
Results First Received: March 13, 2013
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration