Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer

• Sponsor: NCIC Clinical Trials Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00820248
• Collaborator: (none)
• Enrollment: 320
• Locations: 19
• Arms: 2
• Actual Duration (Months): 98
• Patients Per Site: 16.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving standard radiation therapy together with high-dose cisplatin is more effective than giving higher-dose radiation therapy together with panitumumab in treating patients with locally advanced head and neck cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see how well they work when given together with cisplatin or panitumumab in treating patients with locally advanced stage III or stage IV head and neck cancer.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Biological: panitumumab; Drug: cisplatin; Radiation: 3-dimensional conformal radiation therapy; Radiation: accelerated radiation therapy; Radiation: intensity-modulated radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

Primary

• To compare the progression-free survival (PFS) of patients with locally advanced squamous cell carcinoma of the head and neck treated with standard fractionation radiotherapy and high-dose cisplatin vs accelerated fractionation radiotherapy and panitumumab.

Secondary

• To compare overall survival of patients treated with these regimens.

• To compare local and regional PFS of patients treated with these regimens.

• To compare distant metastasis in patients treated with these regimens.

• To compare adverse events, including late radiotherapy-related adverse events in patients treated with these regimens.

• To compare quality of life (QOL) of patients treated with these regimens.

• To compare swallowing-related QOL of patients treated with these regimens.

• To compare economic evaluation (cost effectiveness analysis and cost utility), including both healthcare utilization and indirect costs.

OUTLINE: This is a multicenter study. Patients are stratified according to T category (T1-3 vs T4), nodal status (N0-1 vs N2 vs N3), radiotherapy delivery modality (intensity-modulated [IMRT] vs 3-D conformal [3D CRT]), anatomic location (hypopharynx vs oral cavity vs oropharynx vs larynx), and participation in the optional swallowing impairment substudy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

• Arm II: Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.

Quality of life (QOL) (FACT-H&N), swallowing-related QOL (MDADI, SWAL-QOL), swallowing function (FOIS), and economic evaluations (Lost Productivity questionnaire) are assessed periodically during the study.

After completion of study treatment, patients are followed periodically for at least 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Study of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab in Patients With Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck
• Actual Study Start Date: Dec 18, 2008
• Actual Primary Completion Date: May 16, 2015
• Actual Study Completion Date: Feb 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.	Drug: cisplatin; Given IV; Radiation: 3-dimensional conformal radiation therapy; Patients undergo radiotherapy; Radiation: intensity-modulated radiation therapy; Patients undergo radiotherapy
Experimental: Arm II Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.	Biological: panitumumab; Given IV; Radiation: 3-dimensional conformal radiation therapy; Patients undergo radiotherapy; Radiation: accelerated radiation therapy; Patients undergo accelerated fractionation radiotherapy; Radiation: intensity-modulated radiation therapy; Patients undergo radiotherapy

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) Rate [6.2 years]

   The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event will be reported.

Secondary Outcome Measures

1. Overall Survival Rate [6.2 years]

   Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported.

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

• Locally advanced disease, defined by any of the following criteria:

• Any T, N+, M0

• T3-4, N0, M0

• No current history of unknown primary squamous cell carcinoma of the head and neck, primary nasopharyngeal, paranasal, or salivary gland tumors of the head and neck

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Absolute granulocyte count ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST or ALT ≤ 3 times ULN

• Creatinine clearance > 50 mL/min

• Magnesium > 0.5 mmol/L

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

• Must be accessible for treatment and follow-up

• Able (sufficiently fluent) and willing to complete the quality of life (QOL) and swallowing QOL questionnaires in either English or French

• Must be assessed by a radiation oncologist and medical oncologist and deemed suitable for study participation

• No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other curatively treated solid tumors

• No history of allergic or hypersensitivity reactions to any of the study drugs or their excipients

• No prior or concurrent interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) on baseline CT scan

• No peripheral neuropathy ≥ grade 2 (CTCAE v3.0)

• No hearing loss/tinnitus ≥ grade 3 (CTCAE v3.0)

• No thromboembolic event within the past 12 months despite being treated with anticoagulation drugs

• Prior thromboembolic event > 12 months allowed provided patient is stable on anticoagulation or on preventative anticoagulation

• None of the following allowed:

• Myocardial infarction within the past 12 months

• Uncontrolled severe congestive heart failure

• Unstable angina

• Active cardiomyopathy

• Unstable ventricular arrhythmia

• Uncontrolled hypertension

• Uncontrolled psychiatric disorder

• Active serious infection

• Active peptic ulcer disease

• Any other medical condition that might interfere with protocol therapy delivery

PRIOR CONCURRENT THERAPY:

• No prior surgical treatment except diagnostic biopsy for this disease

• No prior induction chemotherapy for this disease

• No prior radiation to the head and neck region that would result in overlap of fields for this study

• No prior cisplatin or carboplatin chemotherapy

• No prior targeted anti-EGFR therapy of any kind

• At least 30 days since any prior investigational agent

• No concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy

• No concurrent erythropoietic growth factors, pilocarpine, amifostine, other anticancer therapy (e.g., cytotoxic agents, biological response modifiers, immunotherapy, or hormonal therapy), or other investigational drug therapy

• The following radiological investigations must be done within 8 weeks of randomization:

• MRI or CT of the head and neck

• CT chest

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
2	BCCA - Fraser Valley Cancer Centre	Surrey	British Columbia	Canada	V3V 1Z2
3	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
4	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
5	Atlantic Health Sciences Corporation	Saint John	New Brunswick	Canada	E2L 4L2
6	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador	Canada	AIB 3V6
7	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario	Canada	L8V 5C2
8	Cancer Centre of Southeastern Ontario at Kingston	Kingston	Ontario	Canada	K7L 5P9
9	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6
10	Ottawa Health Research Institute - General Division	Ottawa	Ontario	Canada	K1H 8L6
11	Northeast Cancer Center Health Sciences	Sudbury	Ontario	Canada	P3E 5J1
12	Thunder Bay Regional Health Science Centre	Thunder Bay	Ontario	Canada	P7B 6V4
13	Univ. Health Network-Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
14	Hopital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
15	McGill University - Dept. Oncology	Montreal	Quebec	Canada	H2W 1S6
16	CHUQ-Pavillon Hotel-Dieu de Quebec	Quebec City	Quebec	Canada	G1R 2J6
17	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4
18	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
19	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4

Sponsors and Collaborators

• NCIC Clinical Trials Group

Investigators

• Principal Investigator: Lillian L. Siu, MD, FRCPC, Princess Margaret Hospital, Canada
• Study Chair: John Waldron, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ringash J, Waldron JN, Siu LL, Martino R, Winquist E, Wright JR, Nabid A, Hay JH, Hammond A, Sultanem K, Hotte S, Leong C, El-Gayed AA, Naz F, Ramchandar K, Owen TE, Montenegro A, O'Sullivan B, Chen BE, Parulekar WR. Quality of life and swallowing with standard chemoradiotherapy versus accelerated radiotherapy and panitumumab in locoregionally advanced carcinoma of the head and neck: A phase III randomised trial from the Canadian Cancer Trials Group (HN.6). Eur J Cancer. 2017 Feb;72:192-199. doi: 10.1016/j.ejca.2016.11.008. Epub 2016 Dec 29.

• Responsible Party: NCIC Clinical Trials Group
• ClinicalTrials.gov Identifier: NCT00820248
• Other Study ID Numbers: HN6; CAN-NCIC-HN6; CDR0000630159
• First Posted: Jan 12, 2009
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NCIC Clinical Trials Group: stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the oropharynx; stage III verrucous carcinoma of the oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV verrucous carcinoma of the oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity
• Additional relevant MeSH terms: Head and Neck Neoplasms; Panitumumab

Study Results

Participant Flow

Arm/Group Title	Cisplatin	Panitumumab
Arm/Group Description	Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy	Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
Period Title: Overall Study
STARTED	160	160
Received Protocol Treatment	156	159
COMPLETED	156	159
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Cisplatin	Panitumumab	Total
Arm/Group Description	Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy	Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy	Total of all reporting groups
Overall Participants	160	160	320
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.68 (7.50)	56.40 (7.43)	56.54 (7.46)
Sex: Female, Male (Count of Participants)
Female	26 16.3%	26 16.3%	52 16.3%
Male	134 83.8%	134 83.8%	268 83.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.6%	1 0.3%
Asian	1 0.6%	7 4.4%	8 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 0.6%	2 1.3%	3 0.9%
White	158 98.8%	150 93.8%	308 96.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
ECOG Performance Status (Count of Participants)
0	111 69.4%	115 71.9%	226 70.6%
1	49 30.6%	45 28.1%	94 29.4%
Anatomic Location (Count of Participants)
Oral Cavity	2 1.3%	5 3.1%	7 2.2%
Oropharynx	132 82.5%	127 79.4%	259 80.9%
Larynx	18 11.3%	17 10.6%	35 10.9%
Hypopharynx	8 5%	11 6.9%	19 5.9%
Smoking (Count of Participants)
No	47 29.4%	44 27.5%	91 28.4%
Yes	113 70.6%	116 72.5%	229 71.6%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS) Rate
Description	The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event will be reported.
Time Frame	6.2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cisplatin	Panitumumab
Arm/Group Description	Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy	Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
Measure Participants	160	160
PFS event	50 31.3%	43 26.9%
no PFS event	110 68.8%	117 73.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cisplatin, Panitumumab
	Comments	The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio of panitumumab vs cisplatin

2. Secondary Outcome

Title	Overall Survival Rate
Description	Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported.
Time Frame	6.2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cisplatin	Panitumumab
Arm/Group Description	Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy	Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
Measure Participants	160	160
Death	43 26.9%	32 20%
Alive	117 73.1%	128 80%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cisplatin, Panitumumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	hazard ratio for panitumumab vs cisplatin

Adverse Events

Time Frame	6.2 years
Adverse Event Reporting Description	Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
Arm/Group Title	Cisplatin		Panitumumab
Arm/Group Description	Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy		Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
All Cause Mortality
	Cisplatin		Panitumumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/160 (26.9%)		32/160 (20%)
Serious Adverse Events
	Cisplatin		Panitumumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/159 (0%)
Other (Not Including Serious) Adverse Events
	Cisplatin		Panitumumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	156/156 (100%)		159/159 (100%)
Ear and labyrinth disorders
Hearing (monitoring program)	25/156 (16%)		5/159 (3.1%)
Hearing (without monitoring program)	50/156 (32.1%)		20/159 (12.6%)
Pain External ear	2/156 (1.3%)		8/159 (5%)
Pain Middle ear	24/156 (15.4%)		29/159 (18.2%)
Tinnitus	98/156 (62.8%)		18/159 (11.3%)
Endocrine disorders
Hypothyroidism	21/156 (13.5%)		22/159 (13.8%)
Eye disorders
Dry eye	0/156 (0%)		10/159 (6.3%)
Gastrointestinal disorders
Chelitis	1/156 (0.6%)		10/159 (6.3%)
Constipation	123/156 (78.8%)		113/159 (71.1%)
Diarrhea	29/156 (18.6%)		40/159 (25.2%)
Dry mouth	141/156 (90.4%)		146/159 (91.8%)
Dysphagia	144/156 (92.3%)		150/159 (94.3%)
GI - Other	13/156 (8.3%)		16/159 (10.1%)
Heartburn	36/156 (23.1%)		48/159 (30.2%)
Mucositis (clinical exam) Oral cavity	120/156 (76.9%)		120/159 (75.5%)
Mucositis (functional/symptomatic) Oral cavity	51/156 (32.7%)		55/159 (34.6%)
Nausea	136/156 (87.2%)		94/159 (59.1%)
Pain Abdomen NOS	11/156 (7.1%)		12/159 (7.5%)
Pain Oral cavity	32/156 (20.5%)		45/159 (28.3%)
Salivary gland changes	54/156 (34.6%)		67/159 (42.1%)
Teeth	8/156 (5.1%)		6/159 (3.8%)
Vomiting	87/156 (55.8%)		63/159 (39.6%)
General disorders
Edema: head and neck	38/156 (24.4%)		67/159 (42.1%)
Edema: limb	8/156 (5.1%)		6/159 (3.8%)
Fatigue	124/156 (79.5%)		123/159 (77.4%)
Fever	18/156 (11.5%)		17/159 (10.7%)
Pain - Other	26/156 (16.7%)		29/159 (18.2%)
Rigors/chills	4/156 (2.6%)		22/159 (13.8%)
Infections and infestations
Infection - Other	44/156 (28.2%)		39/159 (24.5%)
Infection with normal ANC Catheter-related	10/156 (6.4%)		9/159 (5.7%)
Injury, poisoning and procedural complications
Dermatitis Chemoradiation	64/156 (41%)		80/159 (50.3%)
Dermatitis Radiation	94/156 (60.3%)		72/159 (45.3%)
Investigations
Creatinine	17/156 (10.9%)		0/159 (0%)
Lymphopenia	32/156 (20.5%)		34/159 (21.4%)
Weight loss	136/156 (87.2%)		127/159 (79.9%)
Metabolism and nutrition disorders
Anorexia	74/156 (47.4%)		69/159 (43.4%)
Dehydration	45/156 (28.8%)		38/159 (23.9%)
Musculoskeletal and connective tissue disorders
Fibrosis-deep connective tissue	9/156 (5.8%)		17/159 (10.7%)
Muscle weakness Whole body/generalized	6/156 (3.8%)		11/159 (6.9%)
Osteonecrosis	7/156 (4.5%)		9/159 (5.7%)
Pain Back	8/156 (5.1%)		11/159 (6.9%)
Pain Bone	7/156 (4.5%)		9/159 (5.7%)
Pain Extremity-limb	8/156 (5.1%)		2/159 (1.3%)
Pain Joint	8/156 (5.1%)		10/159 (6.3%)
Pain Neck	20/156 (12.8%)		29/159 (18.2%)
Trismus	20/156 (12.8%)		23/159 (14.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain Tumor pain	25/156 (16%)		17/159 (10.7%)
Nervous system disorders
Dizziness	19/156 (12.2%)		10/159 (6.3%)
Neuropathy-motor	5/156 (3.2%)		8/159 (5%)
Neuropathy-sensory	61/156 (39.1%)		24/159 (15.1%)
Pain Head/headache	33/156 (21.2%)		34/159 (21.4%)
Taste alteration	142/156 (91%)		139/159 (87.4%)
Psychiatric disorders
Insomnia	50/156 (32.1%)		46/159 (28.9%)
Mood alteration Anxiety	22/156 (14.1%)		32/159 (20.1%)
Mood alteration Depression	12/156 (7.7%)		13/159 (8.2%)
Respiratory, thoracic and mediastinal disorders
Cough	29/156 (18.6%)		38/159 (23.9%)
Dyspnea	18/156 (11.5%)		16/159 (10.1%)
Edema, larynx	29/156 (18.6%)		32/159 (20.1%)
Hiccoughs	26/156 (16.7%)		4/159 (2.5%)
Mucositis (clinical exam) Pharynx	52/156 (33.3%)		53/159 (33.3%)
Pain Throat/pharynx/larynx	81/156 (51.9%)		86/159 (54.1%)
Voice changes	76/156 (48.7%)		74/159 (46.5%)
Skin and subcutaneous tissue disorders
Acne	1/156 (0.6%)		147/159 (92.5%)
Alopecia	53/156 (34%)		50/159 (31.4%)
Dermatology - Other	7/156 (4.5%)		35/159 (22%)
Dry skin	10/156 (6.4%)		59/159 (37.1%)
Hand-foot	1/156 (0.6%)		25/159 (15.7%)
Hyperpigmentation	21/156 (13.5%)		33/159 (20.8%)
Hypopigmentation	6/156 (3.8%)		11/159 (6.9%)
Induration	4/156 (2.6%)		9/159 (5.7%)
Pruritus	5/156 (3.2%)		18/159 (11.3%)
Rash	15/156 (9.6%)		12/159 (7.5%)
Sweating	2/156 (1.3%)		10/159 (6.3%)
Telangiectasia	12/156 (7.7%)		10/159 (6.3%)
Vascular disorders
Hypertension	14/156 (9%)		22/159 (13.8%)

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.