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

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

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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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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.
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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

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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 ]

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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 ]

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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 ]

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4. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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

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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