EPIC: Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00468169
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 76.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Cetuximab; Drug: 5-FU; Drug: Hydroxyurea; Radiation: Twice-daily radiation; Drug: Cisplatin; Radiation: Accelerated fraction radiotherapy with concomitant boost	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A: Cetuximab+FHX Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks.	Drug: Cetuximab; 250mg/m2(day 1, weekly x 10); Other Names: Erbitux (R) ; Drug: 5-FU; 600 mg/m2/day; days 0-5 (120 h total) every other week x 5; Drug: Hydroxyurea; 500 mg PO BID, days 0-5 every other week x 5; Radiation: Twice-daily radiation; 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
Experimental: B: Cetuximab + PX Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks.	Drug: Cetuximab; 250mg/m2(day 1, weekly x 10); Other Names: Erbitux (R) ; Drug: Cisplatin; 100 mg/m2, week 1 and 4 on day 1 (or 2); Radiation: Accelerated fraction radiotherapy with concomitant boost; 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [1 years]

   Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

2. Progression Free Survival (PFS) [2 years]

   Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary Outcome Measures

1. Overall Survival (OS) [2 years]

   Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.

2. Objective Response Rate to Induction [Post-Induction (8 weeks)]

   Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

3. Objective Response Rate to CRT [From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks]

   Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.

4. Residual Lymph Node Disease [Up to 10 weeks]

   Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age 18 or older

• Stage III and IV head and neck cancer

• Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area

• No prior chemotherapy or radiotherapy

• Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

• Normal organ and marrow function

Exclusion Criteria:

• Unequivocal demonstration of metastatic disease

• Known severe hypersensitivity to drugs used in the study

• Treatment with a non-approved or investigational drug within 30 days before Day 1

• Incomplete healing from previous surgery

• Pregnancy or breast feeding

• Uncontrolled intercurrent illness including

• Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF

• Acute hepatitis or known HIV

• Severe baseline neurologic deficits

• Prior therapy which specifically and directly targets the EGFR pathway

• Prior severe infusion reaction to a monoclonal antibody

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Bristol-Myers Squibb

Investigators

• Principal Investigator: Everett E Vokes, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00468169
• Other Study ID Numbers: 14401A
• First Posted: May 2, 2007
• Last Update Posted: Oct 9, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by University of Chicago: Cetuximab; Erbitux; locally; advanced; head; neck; cancer; neoplasms; squamous; carcinoma; lymphoepithelioma
• Additional relevant MeSH terms: Head and Neck Neoplasms; Cetuximab; Hydroxyurea

Study Results

Participant Flow

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
Period Title: Overall Study
STARTED	57	53
COMPLETED	56	53
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX	Total
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Total of all reporting groups
Overall Participants	57	53	110
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	56.1	55.6	55.8
Sex: Female, Male (Count of Participants)
Female	8 14%	9 17%	17 15.5%
Male	49 86%	44 83%	93 84.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 19.3%	11 20.8%	22 20%
White	44 77.2%	39 73.6%	83 75.5%
More than one race	2 3.5%	3 5.7%	5 4.5%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	1 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
Measure Participants	57	53
Number (95% Confidence Interval) [Probability (%)]	87.7	92.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A: Cetuximab+FHX
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1225
	Comments	Log-rank test comparing PFS between two treatment arms
	Method	Log Rank
	Comments

2. Primary Outcome

Title	Progression Free Survival (PFS)
Description	Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
Measure Participants	57	53
Number (95% Confidence Interval) [Probability (%)]	82.5	84.9

3. Secondary Outcome

Title	Overall Survival (OS)
Description	Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
Measure Participants	57	53
Number (95% Confidence Interval) [Probability (%)]	91.2	94.3

4. Secondary Outcome

Title	Objective Response Rate to Induction
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	Post-Induction (8 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
Measure Participants	57	53
Complete Response (CR)	7 12.3%	4 7.5%
Partial Response (PR)	47 82.5%	41 77.4%
Stable Disease (SD)	3 5.3%	7 13.2%
Progressive Disease (PD)	0 0%	1 1.9%

5. Secondary Outcome

Title	Objective Response Rate to CRT
Description	Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
Time Frame	From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
Measure Participants	57	53
Count of Participants [Participants]	3 5.3%	4 7.5%

6. Secondary Outcome

Title	Residual Lymph Node Disease
Description	Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node.
Time Frame	Up to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Cetuximab+FHX	B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: 250mg/m2(day 1, weekly x 10); 5-FU: 600 mg/m2/day; days 0-5 (120 h total) every other week x 5 Hydroxyurea: 500 mg PO BID, days 0-5 every other week x 5 Twice-daily radiation: 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)	Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: 250mg/m2(day 1, weekly x 10); Cisplatin: 100 mg/m2, week 1 and 4 on day 1 (or 2) Accelerated fraction radiotherapy with concomitant boost: 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
Measure Participants	57	53
Count of Participants [Participants]	2 3.5%	6 11.3%

Adverse Events

Time Frame	24 months
Arm/Group Title	A: Cetuximab+FHX		B: Cetuximab + PX
Arm/Group Description	Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)		Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
All Cause Mortality
	A: Cetuximab+FHX		B: Cetuximab + PX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/57 (24.6%)		9/53 (17%)
Serious Adverse Events
	A: Cetuximab+FHX		B: Cetuximab + PX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/57 (12.3%)		14/53 (26.4%)
Cardiac disorders
Tachycardia	0/57 (0%)		1/53 (1.9%)
Pericarditis	1/57 (1.8%)		0/53 (0%)
Gastrointestinal disorders
Mucositis oral	0/57 (0%)		1/53 (1.9%)
Diarrhea	1/57 (1.8%)		2/53 (3.8%)
Nausea	2/57 (3.5%)		1/53 (1.9%)
Vomiting	2/57 (3.5%)		1/53 (1.9%)
General disorders
Fever	2/57 (3.5%)		5/53 (9.4%)
Pain	0/57 (0%)		2/53 (3.8%)
Infections and infestations
Infections and infestations - Other, specify	4/57 (7%)		0/53 (0%)
Metabolism and nutrition disorders
Hypoglycemia	0/57 (0%)		1/53 (1.9%)
Hyperglycemia	0/57 (0%)		1/53 (1.9%)
Dehydration	1/57 (1.8%)		3/53 (5.7%)
G-tube placement	1/57 (1.8%)		3/53 (5.7%)
Malnourished	0/57 (0%)		2/53 (3.8%)
Nervous system disorders
Presyncopal episode	0/57 (0%)		1/53 (1.9%)
Vascular disorders
Thromboembolic event	0/57 (0%)		1/53 (1.9%)
Other (Not Including Serious) Adverse Events
	A: Cetuximab+FHX		B: Cetuximab + PX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	57/57 (100%)		53/53 (100%)
Gastrointestinal disorders
Nausea	49/57 (86%)		45/53 (84.9%)
Vomiting	27/57 (47.4%)		19/53 (35.8%)
Mucositis oral	57/57 (100%)		53/53 (100%)
Constipation	46/57 (80.7%)		40/53 (75.5%)
Diarrhea	25/57 (43.9%)		20/53 (37.7%)
General disorders
Fatigue	56/57 (98.2%)		53/53 (100%)
Fever	23/57 (40.4%)		31/53 (58.5%)
Pain	57/57 (100%)		53/53 (100%)
Infections and infestations
Infections and infestations - Other, specify	56/57 (98.2%)		24/53 (45.3%)
Injury, poisoning and procedural complications
Dermatitis radiation	56/57 (98.2%)		53/53 (100%)
Investigations
Weight loss	51/57 (89.5%)		37/53 (69.8%)
Neutrophil count decreased	48/57 (84.2%)		45/53 (84.9%)
Hemoglobin increased	43/57 (75.4%)		36/53 (67.9%)
White blood cell decreased	46/57 (80.7%)		47/53 (88.7%)
Platelet count decreased	13/57 (22.8%)		13/53 (24.5%)
Creatinine increased	6/57 (10.5%)		4/53 (7.5%)
Metabolism and nutrition disorders
Anorexia	41/57 (71.9%)		39/53 (73.6%)
Dehydration	50/57 (87.7%)		49/53 (92.5%)
Nervous system disorders
Nervous system disorders - Other, specify	18/57 (31.6%)		20/53 (37.7%)
Skin and subcutaneous tissue disorders
Alopecia	50/57 (87.7%)		49/53 (92.5%)
Rash maculo-papular	56/57 (98.2%)		53/53 (100%)

Limitations/Caveats

[Not Specified]

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.