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Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix

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ClinicalTrials.gov Identifier: NCT01580410
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Carcinoma of the Appendix
Primary Peritoneal Cavity Cancer
Interventions: Drug: mitomycin C
Drug: oxaliplatin
Procedure: therapeutic conventional surgery
Other: quality-of-life assessment
Drug: hyperthermic intraperitoneal chemotherapy

  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
Arm I (Mitomycin C)

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Arm II (Oxaliplatin)

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC


Participant Flow:   Overall Study
    Arm I (Mitomycin C)   Arm II (Oxaliplatin)
STARTED   68   68 
COMPLETED   57   60 
NOT COMPLETED   11   8 



  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.
No text entered.

Reporting Groups
  Description
Arm I (Mitomycin C)

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Arm II (Oxaliplatin)

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Total Total of all reporting groups

Baseline Measures
   Arm I (Mitomycin C)   Arm II (Oxaliplatin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 68   68   136 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      46  67.6%      48  70.6%      94  69.1% 
>=65 years      22  32.4%      20  29.4%      42  30.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.9  (12.9)   55.0  (14.0)   55.5  (13.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      35  51.5%      40  58.8%      75  55.1% 
Male      33  48.5%      28  41.2%      61  44.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   2.9%      3   4.4%      5   3.7% 
Not Hispanic or Latino      64  94.1%      65  95.6%      129  94.9% 
Unknown or Not Reported      2   2.9%      0   0.0%      2   1.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   1.5%      1   0.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   5.9%      5   7.4%      9   6.6% 
White      63  92.6%      62  91.2%      125  91.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.5%      0   0.0%      1   0.7% 
Region of Enrollment 
[Units: Participants]
     
United States   68   68   136 


  Outcome Measures

1.  Primary:   The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments   [ Time Frame: Within 4 weeks of surgery ]

2.  Secondary:   The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years   [ Time Frame: Time to first progression unless the patient’s resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years ]

3.  Secondary:   The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years   [ Time Frame: Interval between surgery and death or date of last contact, assessed up to 3 years ]

4.  Secondary:   Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)   [ Time Frame: Up to 3 years ]


  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
The worst adverse event of each type was recorded for the course of treatment.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Edward Levine
Organization: Wake Forest University Health Sciences
phone: 336-716-2763
e-mail: elevine@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01580410     History of Changes
Obsolete Identifiers: NCT00904267
Other Study ID Numbers: CCCWFU 59109
NCI-2009-00947 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 17, 2012
First Posted: April 19, 2012
Results First Submitted: December 21, 2017
Results First Posted: March 21, 2018
Last Update Posted: March 21, 2018