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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01580410
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 136
• Locations: 3
• Arms: 2
• Duration (Months): 90.1
• Patients Per Site: 45.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma of the Appendix; Primary Peritoneal Cavity Cancer	Drug: mitomycin C; Drug: oxaliplatin; Procedure: therapeutic conventional surgery; Other: quality-of-life assessment; Drug: hyperthermic intraperitoneal chemotherapy	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To compare the toxicity profiles within 4 weeks of surgery of oxaliplatin and mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy in patients with peritoneal surface malignancies from primary appendiceal tumors.

SECONDARY OBJECTIVES:

1. To compare the time to progression in patients treated with oxaliplatin vs. mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy for surface malignancies from primary appendiceal tumors.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo surgical cytoreduction and receive mitomycin C by hyperthermic intraperitoneal chemotherapy (HIPEC).

Arm II: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, and 36 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After HIPEC With Oxaliplatin or Mitomycin C in Patients With Appendiceal Tumors
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (mitomycin C) Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.	Drug: mitomycin C; Given by HIPEC; Other Names: MITC MITO MITO-C Mitocin-C MTC ; Procedure: therapeutic conventional surgery; Undergo surgery; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment ; Drug: hyperthermic intraperitoneal chemotherapy; Undergo HIPEC
Experimental: Arm II (oxaliplatin) Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.	Drug: oxaliplatin; Given by HIPEC; Other Names: 1-OHP Dacotin Dacplat Eloxatin L-OHP ; Procedure: therapeutic conventional surgery; Undergo surgery; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment ; Drug: hyperthermic intraperitoneal chemotherapy; Undergo HIPEC

Outcome Measures

Primary Outcome Measures

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

   If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.

Secondary Outcome Measures

1. The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years [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]

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

3. Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G) [Throughout study completion, up to 3 years]

   The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed peritoneal surface malignancies from primary appendiceal tumors

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Absolute neutrophil count >= 1,500/mcL

• Platelets >=100,000/mcL

• Total bilirubin =< 1.5 mg/dL

• Creatinine =< 2.0 mg/dL

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 X institutional upper limit of normal

• Alkaline phosphatase =< 3 X institutional upper limit of normal

• Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy, or other antineoplastic therapy

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) for the duration of study participation and for 90 days following HIPEC

• Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

• Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol

Exclusion Criteria:

• Patients with an active infection or with a fever >= 101.3 degrees Fahrenheit (F) within 3 days of the first scheduled day of protocol treatment

• Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)

• Patients with carcinoid tumors

• Patients with active central nervous system (CNS) metastases

• Patients with known hypersensitivity to any of the components of oxaliplatin or mitomycin C

• History of prior malignancy within the past 5 years, except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen (PSA) of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry

• Patients who received radiotherapy to more than 25% of their bone marrow

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant/nursing women are excluded from this study because oxaliplatin is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin, breastfeeding should be discontinued if the mother is treated with oxaliplatin or mitomycin C

• Known human immunodeficiency virus (HIV), hepatitis B or C-positive patients (active, previously treated or both)

• Peripheral neuropathy >= grade 2

• History of allogenic transplant

• History of prior HIPEC

• Evidence of metastatic disease outside of the abdomen

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
2	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
3	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Edward Levine, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01580410
• Other Study ID Numbers: IRB00009326; NCI-2009-00947; CCCWFU 59109; NCT00904267
• First Posted: Apr 19, 2012
• Last Update Posted: Jul 3, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peritoneal Neoplasms; Oxaliplatin; Mitomycins; Mitomycin

Study Results

Participant Flow

Arm/Group Title	Arm I (Mitomycin C)	Arm II (Oxaliplatin)
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	68	68
COMPLETED	57	60
NOT COMPLETED	11	8

Baseline Characteristics

Arm/Group Title	Arm I (Mitomycin C)	Arm II (Oxaliplatin)	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	68	68	136
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.9 (12.9)	55.0 (14.0)	55.5 (13.4)
Sex: Female, Male (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) (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%	2 1.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 1.5%	1 0.7%
Native Hawaiian or Other Pacific Islander	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%
Unknown or Not Reported	1 1.5%	0 0%	1 0.7%
Region of Enrollment (participants) [Number]
United States	68 100%	68 100%	136 100%

Outcome Measures

1. Primary Outcome

Title	The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments
Description	If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.
Time Frame	Within 4 weeks of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Mitomycin C)	Arm II (Oxaliplatin)
Arm/Group Description	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	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
Measure Participants	61	59
Number [number of patients with toxicities]	8	5

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Mitomycin C)	Arm II (Oxaliplatin)
Arm/Group Description	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	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
Measure Participants	57	53
Mean (Standard Error) [disease-free survival rate (%)]	61.6 (8.1)	59.4 (8.1)

3. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Mitomycin C)	Arm II (Oxaliplatin)
Arm/Group Description	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	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
Measure Participants	57	53
Mean (Standard Error) [overall survival rate (%)]	75.7 (6.4)	79.3 (5.7)

4. Secondary Outcome

Title	Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)
Description	The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.
Time Frame	Throughout study completion, up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Mitomycin C)	Arm II (Oxaliplatin)
Arm/Group Description	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	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
Measure Participants	57	53
Mean (Standard Error) [units on a scale]	85.5 (1.6)	89.6 (1.7)

Adverse Events

Arm/Group Title	Arm I (Mitomycin C)		Arm II (Oxaliplatin)
Arm/Group Description	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		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
All Cause Mortality
	Arm I (Mitomycin C)		Arm II (Oxaliplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/58 (1.7%)		1/61 (1.6%)
Serious Adverse Events
	Arm I (Mitomycin C)		Arm II (Oxaliplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/58 (87.9%)		54/61 (88.5%)
Cardiac disorders
Hypotension	2/58 (3.4%)	2	3/61 (4.9%)	3
Atrial fibrillation	2/58 (3.4%)	2	2/61 (3.3%)	2
Sinus tachycardia	1/58 (1.7%)	1	2/61 (3.3%)	2
Gastrointestinal disorders
Nausea	7/58 (12.1%)	7	10/61 (16.4%)	10
Diarrhea	3/58 (5.2%)	3	9/61 (14.8%)	9
Obstruction, GI: Small bowel	1/58 (1.7%)	1	1/61 (1.6%)	1
functional obstruction of bowel	8/58 (13.8%)	8	10/61 (16.4%)	10
Malabsorption	2/58 (3.4%)	2	4/61 (6.6%)	4
Fistula, GI: Abdomen	2/58 (3.4%)	2	0/61 (0%)	0
Leak (including anastomotic), GI: Leak	1/58 (1.7%)	1	1/61 (1.6%)	1
Leak (including anastomotic), GI: Small bowel	1/58 (1.7%)	1	0/61 (0%)	0
Necrosis, GI: Small bowel	1/58 (1.7%)	1	0/61 (0%)	0
General disorders
Anorexia	10/58 (17.2%)	10	8/61 (13.1%)	8
Fatigue	6/58 (10.3%)	6	7/61 (11.5%)	7
Weight loss	4/58 (6.9%)	4	2/61 (3.3%)	2
Dehydration	1/58 (1.7%)	1	5/61 (8.2%)	5
Confusion	1/58 (1.7%)	1	1/61 (1.6%)	1
Mood alteration: Agitation	4/58 (6.9%)	4	2/61 (3.3%)	2
Anxiety	1/58 (1.7%)	1	2/61 (3.3%)	2
Depression	1/58 (1.7%)	1	1/61 (1.6%)	1
Pain: Abdomen	5/58 (8.6%)	5	4/61 (6.6%)	4
Pain: Chest/thorax	1/58 (1.7%)	1	0/61 (0%)	0
Death not associated with CTCAE term: Multi-organ failure	1/58 (1.7%)	1	0/61 (0%)	0
Pain: Muscle	2/58 (3.4%)	2	3/61 (4.9%)	3
Pain: Scrotum	1/58 (1.7%)	1	0/61 (0%)	0
Mental status	1/58 (1.7%)	1	0/61 (0%)	0
Infections and infestations
Infection Bladder	1/58 (1.7%)	1	1/61 (1.6%)	1
Cystitis	1/58 (1.7%)	1	0/61 (0%)	0
infection associated with Lymphopenia	1/58 (1.7%)	1	1/61 (1.6%)	1
Lung infection	9/58 (15.5%)	9	10/61 (16.4%)	11
Urinary with low grade neutropenia	2/58 (3.4%)	2	0/61 (0%)	0
Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen	3/58 (5.2%)	3	1/61 (1.6%)	1
Infection with normal ANC or Grade 1 or 2 neutrophils: Peritoneal cavity	2/58 (3.4%)	2	2/61 (3.3%)	2
Lung Infection with high grade neutropenia	1/58 (1.7%)	1	0/61 (0%)	0
Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis	1/58 (1.7%)	1	0/61 (0%)	0
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound	1/58 (1.7%)	1	1/61 (1.6%)	1
Infection with unknown ANC: Peritoneal cavity	1/58 (1.7%)	1	0/61 (0%)	0
Infection with high grade neutropenia	1/58 (1.7%)	1	0/61 (0%)	0
Blood Infection with high grade neutropenia	3/58 (5.2%)	3	1/61 (1.6%)	1
Investigations
Low WBC	3/58 (5.2%)	3	2/61 (3.3%)	2
low Platelets	1/58 (1.7%)	1	3/61 (4.9%)	4
Low Hemoglobin	35/58 (60.3%)	35	36/61 (59%)	36
Creatinine	1/58 (1.7%)	1	0/61 (0%)	0
Low ANC	1/58 (1.7%)	1	4/61 (6.6%)	4
hyperglycemia	3/58 (5.2%)	3	6/61 (9.8%)	6
hypocalcemia	1/58 (1.7%)	1	0/61 (0%)	0
hyponatremia	3/58 (5.2%)	3	2/61 (3.3%)	2
hypokalemia	7/58 (12.1%)	7	1/61 (1.6%)	1
hypoalbuminemia	16/58 (27.6%)	16	19/61 (31.1%)	19
hyperbilirubinemia	1/58 (1.7%)	1	0/61 (0%)	0
serum glutamic pyruvic transaminase	12/58 (20.7%)	12	9/61 (14.8%)	9
hypophosphatemia	13/58 (22.4%)	13	14/61 (23%)	14
serum glutamic oxaloacetic transaminase	16/58 (27.6%)	16	7/61 (11.5%)	7
Acidosis	2/58 (3.4%)	2	4/61 (6.6%)	4
creatine phosphokinase	1/58 (1.7%)	1	0/61 (0%)	0
disseminated intravascular coagulation	1/58 (1.7%)	1	0/61 (0%)	0
Prolonged QTc interval	1/58 (1.7%)	1	0/61 (0%)	0
Lymphopenia	20/58 (34.5%)	21	25/61 (41%)	28
International Normalized Ratio of prothrombin time	1/58 (1.7%)	1	0/61 (0%)	0
Cardiac troponin I	1/58 (1.7%)	1	1/61 (1.6%)	1
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided	1/58 (1.7%)	1	0/61 (0%)	0
Renal and urinary disorders
Renal failure	2/58 (3.4%)	2	3/61 (4.9%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnea	11/58 (19%)	11	14/61 (23%)	14
Pneumonitis/pulmonary infiltrates	1/58 (1.7%)	1	5/61 (8.2%)	5
Pleural effusion (non-malignant)	7/58 (12.1%)	7	8/61 (13.1%)	8
Cough	1/58 (1.7%)	1	0/61 (0%)	0
Pneumothorax	1/58 (1.7%)	1	0/61 (0%)	0
Prolonged intubation after pulmonary resection (>24 hrs after surgery)	2/58 (3.4%)	2	3/61 (4.9%)	3
Skin and subcutaneous tissue disorders
Pain: Skin	1/58 (1.7%)	1	0/61 (0%)	0
Ulceration	1/58 (1.7%)	1	0/61 (0%)	0
Vascular disorders
Hemorrhage, GI: Lower GI	2/58 (3.4%)	2	1/61 (1.6%)	1
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative	2/58 (3.4%)	2	0/61 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm I (Mitomycin C)		Arm II (Oxaliplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	58/58 (100%)		61/61 (100%)
Blood and lymphatic system disorders
Hematoma	1/58 (1.7%)	1	1/61 (1.6%)	1
Cardiac disorders
Hypotension	8/58 (13.8%)	8	4/61 (6.6%)	4
Neuropathy: sensory	6/58 (10.3%)	7	1/61 (1.6%)	1
Cardiac Arrhythmia - Other	1/58 (1.7%)	1	0/61 (0%)	0
Conduction abnormality/atrioventricular heart block	1/58 (1.7%)	1	0/61 (0%)	0
Right ventricular dysfunction	1/58 (1.7%)	1	0/61 (0%)	0
Supraventricular and nodal arrhythmia: Sinus bradycardia	2/58 (3.4%)	2	0/61 (0%)	0
Sinus tachycardia	9/58 (15.5%)	9	5/61 (8.2%)	5
Supraventricular and nodal arrhythmia: Supraventricular tachycardia	1/58 (1.7%)	1	3/61 (4.9%)	3
Eye disorders
Watery eye (epiphora, tearing)	1/58 (1.7%)	1	0/61 (0%)	0
Gastrointestinal disorders
Nausea	19/58 (32.8%)	19	18/61 (29.5%)	18
Vomiting	24/58 (41.4%)	24	17/61 (27.9%)	17
Diarrhea	18/58 (31%)	18	8/61 (13.1%)	8
Constipation	6/58 (10.3%)	6	4/61 (6.6%)	4
Ascites (non-malignant)	2/58 (3.4%)	2	0/61 (0%)	0
Flatulence	2/58 (3.4%)	2	1/61 (1.6%)	1
functional obstruction of bowel	5/58 (8.6%)	5	4/61 (6.6%)	4
Leak (including anastomotic), GI: Pancreas	1/58 (1.7%)	1	0/61 (0%)	0
Leak (including anastomotic), GI: Leak	1/58 (1.7%)	1	0/61 (0%)	0
General disorders
Anorexia	20/58 (34.5%)	20	19/61 (31.1%)	19
Hypertension	2/58 (3.4%)	2	3/61 (4.9%)	3
Taste alteration	4/58 (6.9%)	4	4/61 (6.6%)	4
Insomnia	11/58 (19%)	11	5/61 (8.2%)	5
Rigors/chills	1/58 (1.7%)	1	1/61 (1.6%)	1
Sweating	2/58 (3.4%)	2	0/61 (0%)	0
Fatigue	30/58 (51.7%)	30	22/61 (36.1%)	22
Weight loss	26/58 (44.8%)	26	34/61 (55.7%)	34
Dysphagia	1/58 (1.7%)	1	0/61 (0%)	0
Fever without neutropenia	6/58 (10.3%)	6	5/61 (8.2%)	5
Constitutional Symptoms - Other	1/58 (1.7%)	1	0/61 (0%)	0
Edema: trunk/genital	1/58 (1.7%)	1	1/61 (1.6%)	1
Dehydration	2/58 (3.4%)	2	2/61 (3.3%)	2
Confusion	2/58 (3.4%)	2	0/61 (0%)	0
Mood alteration: Agitation	1/58 (1.7%)	1	0/61 (0%)	0
Anxiety	5/58 (8.6%)	5	4/61 (6.6%)	4
Depression	1/58 (1.7%)	1	1/61 (1.6%)	1
Distension bloating, abdominal	4/58 (6.9%)	4	1/61 (1.6%)	1
Pain: Abdomen	8/58 (13.8%)	8	18/61 (29.5%)	18
Pain: Joint	2/58 (3.4%)	2	1/61 (1.6%)	1
Pain: Back	2/58 (3.4%)	2	0/61 (0%)	0
Pain Bladder	1/58 (1.7%)	1	1/61 (1.6%)	1
Wound complication, non-infectious	10/58 (17.2%)	10	8/61 (13.1%)	8
Hiccoughs (hiccups, singultus)	2/58 (3.4%)	2	1/61 (1.6%)	1
Pain: Muscle	4/58 (6.9%)	4	5/61 (8.2%)	5
Pain: Neuralgia/peripheral nerve	1/58 (1.7%)	1	0/61 (0%)	0
Pain Oral cavity	1/58 (1.7%)	1	0/61 (0%)	0
Pain: Stomach	1/58 (1.7%)	1	0/61 (0%)	0
Pain: Urethra	1/58 (1.7%)	1	0/61 (0%)	0
Cognitive disturbance	1/58 (1.7%)	1	1/61 (1.6%)	1
Intra-operative injury: NERVES: Peripheral sensory	1/58 (1.7%)	1	0/61 (0%)	0
Infections and infestations
Infection Bladder	1/58 (1.7%)	1	1/61 (1.6%)	1
Lung infection	2/58 (3.4%)	2	0/61 (0%)	0
Urinary with low grade neutropenia	1/58 (1.7%)	1	1/61 (1.6%)	1
Mucositis/stomatitis Oral cavity	1/58 (1.7%)	1	2/61 (3.3%)	2
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound	2/58 (3.4%)	2	1/61 (1.6%)	1
Investigations
Low WBC	11/58 (19%)	11	22/61 (36.1%)	22
low Platelets	33/58 (56.9%)	33	27/61 (44.3%)	27
Low Hemoglobin	22/58 (37.9%)	22	22/61 (36.1%)	22
Alkaline phosphatase	31/58 (53.4%)	31	27/61 (44.3%)	27
Creatinine	2/58 (3.4%)	2	2/61 (3.3%)	2
Proteinuria	2/58 (3.4%)	2	1/61 (1.6%)	1
Low ANC	2/58 (3.4%)	2	3/61 (4.9%)	3
hyperglycemia	42/58 (72.4%)	42	42/61 (68.9%)	42
hypocalcemia	3/58 (5.2%)	3	4/61 (6.6%)	4
hypomagnesemia	8/58 (13.8%)	8	6/61 (9.8%)	6
hyponatremia	35/58 (60.3%)	35	29/61 (47.5%)	29
hypokalemia	26/58 (44.8%)	26	31/61 (50.8%)	31
Bicarbonate serum-low	2/58 (3.4%)	2	0/61 (0%)	0
hypoalbuminemia	33/58 (56.9%)	33	35/61 (57.4%)	35
hyperbilirubinemia	2/58 (3.4%)	2	4/61 (6.6%)	4
serum glutamic pyruvic transaminase	31/58 (53.4%)	31	37/61 (60.7%)	37
hypophosphatemia	5/58 (8.6%)	5	6/61 (9.8%)	6
serum glutamic oxaloacetic transaminase	31/58 (53.4%)	31	43/61 (70.5%)	43
hypermagnesemia	2/58 (3.4%)	2	1/61 (1.6%)	1
hyperkalemia	2/58 (3.4%)	2	4/61 (6.6%)	4
hypernatremia	2/58 (3.4%)	2	1/61 (1.6%)	1
hypertriglyceridemia	1/58 (1.7%)	1	0/61 (0%)	0
Lymphopenia	24/58 (41.4%)	24	21/61 (34.4%)	21
International Normalized Ratio of prothrombin time	1/58 (1.7%)	1	1/61 (1.6%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	6/58 (10.3%)	6	3/61 (4.9%)	3
Pleural effusion (non-malignant)	19/58 (32.8%)	19	10/61 (16.4%)	10
Cough	6/58 (10.3%)	6	2/61 (3.3%)	2
Atelectasis	20/58 (34.5%)	20	16/61 (26.2%)	16
Pneumothorax	3/58 (5.2%)	3	5/61 (8.2%)	5
Infection with unknown ANC Lung (pneumonia)	1/58 (1.7%)	1	0/61 (0%)	0
Prolonged chest tube drainage or air leak after pulmonary resection	1/58 (1.7%)	1	0/61 (0%)	0
Skin and subcutaneous tissue disorders
Dermatology/Skin	1/58 (1.7%)	1	0/61 (0%)	0
Rash/desquamation	1/58 (1.7%)	1	1/61 (1.6%)	1
Rash: acne/acneiform	1/58 (1.7%)	1	1/61 (1.6%)	1
Skin breakdown/decubitus ulcer	1/58 (1.7%)	1	2/61 (3.3%)	2
Vascular disorders
Thrombosis/thrombus/embolism	2/58 (3.4%)	2	1/61 (1.6%)	1
Phlebitis	1/58 (1.7%)	1	0/61 (0%)	0
Edema: limb	2/58 (3.4%)	2	3/61 (4.9%)	3
Edema: viscera	3/58 (5.2%)	3	1/61 (1.6%)	1
Hemorrhage GU: Urinary	3/58 (5.2%)	3	2/61 (3.3%)	2
Thrombosis/embolism (vascular access-related)	1/58 (1.7%)	1	0/61 (0%)	0

Limitations/Caveats

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.

There is NOT 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.