Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy

• Sponsor: Radiation Therapy Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00077064
• Collaborator: National Cancer Institute (NCI) (NIH), NRG Oncology (Other)
• Enrollment: 81
• Locations: 87
• Arms: 2
• Duration (Months): 162
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation therapy, and may improve the quality of life of patients with non-small cell lung cancer or limited-stage small cell lung cancer.

PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing side effects and improving the quality of life in patients who have received radiation therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung cancer or limited-stage small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Pulmonary Complications; Radiation Fibrosis	Drug: captopril	Phase 2

Detailed Description

OBJECTIVES:

• Determine the effect of captopril on the incidence of pulmonary damage at 12 months after radiotherapy with or without chemotherapy in patients with stage II-IIIB non-small cell lung cancer, stage I central non-small cell lung cancer, or limited stage small cell lung cancer.

• Compare the quality of life of patients treated with captopril vs patients who undergo post-radiotherapy observation only.

• Determine the persistence of captopril's effect on pulmonary toxicity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, total lung irradiated (< 25% vs 25-37% vs more than 37%), prior surgery (yes vs no), and prior chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral captopril 3 times daily for 1 year in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients undergo observation only for 1 year. Quality of life is assessed at baseline and at months 3, 6, 12, and 18.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study within 18 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Observation Clinical observation
Experimental: Captopril Captopril	Drug: captopril; Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).

Outcome Measures

Primary Outcome Measures

1. Incidence of Therapy-induced Lung Toxicity [Once all patients have been followed for at least 12 months]

   Incidence of Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation. Assuming that the incidence of pulmonary toxicity would be 50%, based on Fisher's exact test with a one-sided significance level of 0.05,168 randomized patients would be required to have 80% statistical power to detect a 40% relative reduction (from 50% to 30%) in the incidence of pulmonary toxicity while receiving captopril. Assuming that 15% of cases would not continue to the randomization stage and 5% of patients would be found ineligible, the target sample size was 205 patients. Given the actual sample size, power would be 25% and therefore p-values were not reported.

Secondary Outcome Measures

1. Correlation of Lung Toxicities With Biochemical Markers [Once all patients have been followed for at least 12 months]

   Biomarker data will not be generated from these tissue specimens, therefore this analysis will not take place.

2. Correlation of Quality of Life With Late Effects as Measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or EORTC Lung Cancer Module (LC-13) [Baseline to 18 months post treatment]

   Only 2 patients have the required data- only 1.2% of the planned enrollment and 2.5% of the actual enrollment- which is extremely problematic as this data cannot be generalized, leads to selection bias, and is not representative of the patient population. Therefore the analysis was not conducted.

3. Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment [2 years from completion of study treatment]

   Patients who experienced a Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation were assessed to determine if the toxicity persisted for 2 years.

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• One of the following histologically or cytologically confirmed diagnoses:

• Stage II-IIIB non-small cell lung cancer (NSCLC)

• Stage I central NSCLC

• No peripheral coin lesions

• Limited stage small cell lung cancer

• Nonmetastatic disease that is receiving radiotherapy and the target is confined to a single radiotherapy treatment area

• Planning to receive radiotherapy

• At least 45 Gy to be delivered to the target volume

• More than 25% of total lung volume to receive > 20 Gy if receiving radiotherapy alone

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Hematopoietic

• Absolute granulocyte count greater than 1,000/mm^3

• Platelet count greater than 75,000/mm^3

• Hemoglobin greater than 9.0 g/dL (transfusion allowed)

Hepatic

• Bilirubin less than 1.5 mg/dL

• Serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal

Renal

• Blood urea nitrogen (BUN) less than 25 mg/dL

• Creatinine less than 1.6 mg/dL

• Urine protein less than 10 mg/dL

• Urine glucose negative

Cardiovascular

• Systolic blood pressure greater than 110 mm Hg

• Diastolic blood pressure greater than 60 mm Hg

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Sodium normal

• Potassium normal

• No collagen vascular disease (e.g., lupus or scleroderma)

• Rheumatoid arthritis allowed

• No known hypersensitivity to ACE inhibitors

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Induction or concurrent chemotherapy allowed either during radiotherapy or during therapy with captopril

• No concurrent methotrexate

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• Prior pulmonary lobectomy or segmentectomy allowed

• No prior pneumonectomy

Other

• No concurrent angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists for hypertension or congestive heart failure

• No concurrent lithium

• No concurrent procainamide

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama	United States	35294
2	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36652-2144
3	Arizona Oncology Services Foundation	Phoenix	Arizona	United States	85013
4	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
5	Veterans Affairs Medical Center - Long Beach	Long Beach	California	United States	90822
6	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center	Pomona	California	United States	91767
7	General Robert Huyser Cancer Center at David Grant Medical Center	Travis Air Force Base	California	United States	94535-1800
8	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
9	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0232
10	Baptist-South Miami Regional Cancer Program	Miami	Florida	United States	33176
11	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
12	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
13	Saint John's Cancer Center at Saint John's Medical Center	Anderson	Indiana	United States	46016
14	Methodist Cancer Center at Methodist Hospital	Indianapolis	Indiana	United States	46202
15	Cancer Treatment Center for Southern Kentucky	Bowling Green	Kentucky	United States	42101
16	Central Baptist Hospital	Lexington	Kentucky	United States	40503-9985
17	Central Maine Comprehensive Cancer Center at Central Maine Medical Center	Lewiston	Maine	United States	04240
18	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
19	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
20	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
21	Great Lakes Cancer Institute at McLaren Regional Medical Center	Flint	Michigan	United States	48532
22	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
23	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
24	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
25	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
26	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
27	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
28	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
29	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
30	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Cape Girardeau	Missouri	United States	63701
31	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
32	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
33	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
34	Monmouth Medical Center	Long Branch	New Jersey	United States	07740-6395
35	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey	United States	08053
36	J. Phillip Citta Regional Cancer Center at Community Medical Center	Toms River	New Jersey	United States	08755
37	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
38	New York Methodist Hospital	Brooklyn	New York	United States	11215
39	Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center	Plattsburgh	New York	United States	12901
40	Highland Hospital of Rochester	Rochester	New York	United States	14620
41	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
42	Mission Hospitals - Memorial Campus	Asheville	North Carolina	United States	28801
43	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
44	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
45	Cancer Centers of North Carolina - Raleigh	Raleigh	North Carolina	United States	27607
46	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina	United States	27607
47	Wilmed Radiation Oncology Services	Wilson	North Carolina	United States	27893
48	Trinity CancerCare Center	Minot	North Dakota	United States	58701
49	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
50	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
51	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
52	CCOP - Columbus	Columbus	Ohio	United States	43215
53	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
54	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
55	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
56	Grady Memorial Hospital	Delaware	Ohio	United States	43015
57	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
58	Fairfield Medical Center	Lancaster	Ohio	United States	43130
59	Lima Memorial Hospital	Lima	Ohio	United States	45804
60	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
61	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
62	St. Luke's Hospital	Maumee	Ohio	United States	43537
63	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
64	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
65	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
66	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
67	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
68	Mercy Medical Center	Springfield	Ohio	United States	45504
69	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
70	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
71	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
72	Toledo Hospital	Toledo	Ohio	United States	43606
73	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
74	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
75	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
76	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
77	Fulton County Health Center	Wauseon	Ohio	United States	43567
78	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
79	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
80	CCOP - Greenville	Greenville	South Carolina	United States	29615
81	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
82	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
83	Columbia Saint Mary's Hospital - Ozaukee	Mequon	Wisconsin	United States	53097
84	Columbia-Saint Mary's Cancer Care Center	Milwaukee	Wisconsin	United States	53211
85	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
86	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin	United States	53405
87	West Allis Memorial Hospital	West Allis	Wisconsin	United States	53227

Sponsors and Collaborators

• Radiation Therapy Oncology Group
• National Cancer Institute (NCI)
• NRG Oncology

Investigators

• Study Chair: William Small, MD, Robert H. Lurie Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radiation Therapy Oncology Group
• ClinicalTrials.gov Identifier: NCT00077064
• Other Study ID Numbers: RTOG-0123; CDR0000315569; RTOG-L-0123
• First Posted: Feb 11, 2004
• Last Update Posted: Mar 8, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Radiation Therapy Oncology Group: radiation fibrosis; pulmonary complications; limited stage small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage I non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Radiation Pneumonitis; Fibrosis; Captopril

Study Results

Participant Flow

Pre-assignment Detail	Patients were registered within 7 days prior to start of radiation therapy(RT) or during RT up to 48 hours prior completion of RT. They were randomized to captopril or observation within 48 hours prior to completion of RT. Eighty-one patients were registered, 48 did not continue to treatment assignment, 33 were randomized.

Arm/Group Title	Clinical Observation	Captopril
Arm/Group Description	Clinical observation	Captopril: 50 mg t.i.d.
Period Title: Overall Study
STARTED	17	16
COMPLETED	17	10
NOT COMPLETED	0	6

Baseline Characteristics

Arm/Group Title	Observation	Captopril	Total
Arm/Group Description	Clinical observation	Captopril: 50 mg t.i.d.	Total of all reporting groups
Overall Participants	17	10	27
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	67	64	65
Sex: Female, Male (Count of Participants)
Female	9 52.9%	5 50%	14 51.9%
Male	8 47.1%	5 50%	13 48.1%

Outcome Measures

1. Primary Outcome

Title	Incidence of Therapy-induced Lung Toxicity
Description	Incidence of Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation. Assuming that the incidence of pulmonary toxicity would be 50%, based on Fisher's exact test with a one-sided significance level of 0.05,168 randomized patients would be required to have 80% statistical power to detect a 40% relative reduction (from 50% to 30%) in the incidence of pulmonary toxicity while receiving captopril. Assuming that 15% of cases would not continue to the randomization stage and 5% of patients would be found ineligible, the target sample size was 205 patients. Given the actual sample size, power would be 25% and therefore p-values were not reported.
Time Frame	Once all patients have been followed for at least 12 months

Outcome Measure Data

Analysis Population Description

Randomized eligible patients who started study drug treatment and were followed for one year after completion of radiation treatment or experienced radiation-induced pulmonary toxicity.

Arm/Group Title	Observation	Captopril
Arm/Group Description	Clinical observation	Captopril: 50 mg t.i.d.
Measure Participants	13	7
Number (95% Confidence Interval) [percentage of participants]	23 135.3%	14 140%

2. Secondary Outcome

Title	Correlation of Lung Toxicities With Biochemical Markers
Description	Biomarker data will not be generated from these tissue specimens, therefore this analysis will not take place.
Time Frame	Once all patients have been followed for at least 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clinical Observation	Captopril
Arm/Group Description	Clinical observation	Captopril: 50 mg t.i.d.
Measure Participants	0	0

3. Secondary Outcome

Title	Correlation of Quality of Life With Late Effects as Measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or EORTC Lung Cancer Module (LC-13)
Description	Only 2 patients have the required data- only 1.2% of the planned enrollment and 2.5% of the actual enrollment- which is extremely problematic as this data cannot be generalized, leads to selection bias, and is not representative of the patient population. Therefore the analysis was not conducted.
Time Frame	Baseline to 18 months post treatment

Outcome Measure Data

Analysis Population Description

Eligible patients with late effect and baseline and 12-month EORTC data

Arm/Group Title	Clinical Observation	Captopril
Arm/Group Description	Clinical observation	Captopril: 50 mg t.i.d.
Measure Participants	2	0
Count of Participants [Participants]	NA NaN

4. Secondary Outcome

Title	Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment
Description	Patients who experienced a Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation were assessed to determine if the toxicity persisted for 2 years.
Time Frame	2 years from completion of study treatment

Outcome Measure Data

Analysis Population Description

Randomized patients who received study drug treatment and experienced lung toxicity at 1 year

Arm/Group Title	Clinical Observation	Captopril
Arm/Group Description	Clinical observation	Captopril: 50 mg t.i.d.
Measure Participants	3	1
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Adverse Event Reporting Description	Adverse events reported for all eligible randomized patients who were randomized to captopril or observation. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Arm/Group Title	Clinical Observation		Captopril
Arm/Group Description	Clinical observation		Captopril: 50 mg t.i.d.
All Cause Mortality
	Clinical Observation		Captopril
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Clinical Observation		Captopril
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/17 (47.1%)		8/10 (80%)
Cardiac disorders
Cardiac General - Other:	0/17 (0%)		1/10 (10%)
Gastrointestinal disorders
Dysphagia	1/17 (5.9%)		2/10 (20%)
Esophageal pain	1/17 (5.9%)		1/10 (10%)
Esophageal stenosis acquired	1/17 (5.9%)		0/10 (0%)
Nausea	0/17 (0%)		1/10 (10%)
Oseophagitis NOS	1/17 (5.9%)		1/10 (10%)
General disorders
Chest pain	0/17 (0%)		1/10 (10%)
Death NOS	0/17 (0%)		1/10 (10%)
Disease progression NOS	1/17 (5.9%)		0/10 (0%)
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Urinary tract NOS	0/17 (0%)		1/10 (10%)
Injury, poisoning and procedural complications
Vessel injury-vein: SVC	1/17 (5.9%)		0/10 (0%)
Investigations
Lymphopenia	2/17 (11.8%)		1/10 (10%)
Metabolism and nutrition disorders
Dehydration	0/17 (0%)		1/10 (10%)
Hyperglycaemia NOS	1/17 (5.9%)		1/10 (10%)
Hypokalemia	0/17 (0%)		1/10 (10%)
Musculoskeletal and connective tissue disorders
Back pain	1/17 (5.9%)		0/10 (0%)
Muscle weakness NOS	1/17 (5.9%)		0/10 (0%)
Myalgia	0/17 (0%)		1/10 (10%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	1/17 (5.9%)		0/10 (0%)
Nervous system disorders
Peripheral sensory neuropathy	1/17 (5.9%)		0/10 (0%)
Syncope	0/17 (0%)		2/10 (20%)
Psychiatric disorders
Depression	0/17 (0%)		1/10 (10%)
Respiratory, thoracic and mediastinal disorders
Cough	1/17 (5.9%)		2/10 (20%)
Dyspnoea	2/17 (11.8%)		2/10 (20%)
Hypoxia	1/17 (5.9%)		0/10 (0%)
Pleural effusion	2/17 (11.8%)		1/10 (10%)
Pneumothorax NOS	0/17 (0%)		1/10 (10%)
Pulmonary/upper respiratory - Other:	1/17 (5.9%)		1/10 (10%)
Vascular disorders
Hypotension NOS	0/17 (0%)		1/10 (10%)
Thrombosis	1/17 (5.9%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Clinical Observation		Captopril
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/17 (47.1%)		8/10 (80%)
Cardiac disorders
Atrial fibrillation	1/17 (5.9%)		0/10 (0%)
Palpitations	1/17 (5.9%)		0/10 (0%)
Sinus tachycardia	1/17 (5.9%)		0/10 (0%)
Eye disorders
Vision blurred	1/17 (5.9%)		0/10 (0%)
Gastrointestinal disorders
Abdominal pain NOS	1/17 (5.9%)		0/10 (0%)
Constipation	1/17 (5.9%)		1/10 (10%)
Dysphagia	1/17 (5.9%)		2/10 (20%)
Oseophagitis NOS	1/17 (5.9%)		1/10 (10%)
Salivary gland disorder NOS	1/17 (5.9%)		0/10 (0%)
General disorders
Fatigue	5/17 (29.4%)		6/10 (60%)
Infections and infestations
Infection - Other:	1/17 (5.9%)		0/10 (0%)
Injury, poisoning and procedural complications
Dermatitis radiation NOS	1/17 (5.9%)		0/10 (0%)
Investigations
Alanine aminotransferase increased	1/17 (5.9%)		0/10 (0%)
Metabolic/laboratory - Other:	1/17 (5.9%)		0/10 (0%)
Metabolism and nutrition disorders
Anorexia	1/17 (5.9%)		1/10 (10%)
Hyperkalaemia	1/17 (5.9%)		0/10 (0%)
Hypoalbuminemia	1/17 (5.9%)		0/10 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	1/17 (5.9%)		0/10 (0%)
Nervous system disorders
Dizziness	1/17 (5.9%)		3/10 (30%)
Headache	1/17 (5.9%)		2/10 (20%)
Peripheral sensory neuropathy	4/17 (23.5%)		0/10 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	3/17 (17.6%)		4/10 (40%)
Dyspnoea	3/17 (17.6%)		4/10 (40%)
Pharyngolaryngeal pain	1/17 (5.9%)		0/10 (0%)
Pleural effusion	2/17 (11.8%)		0/10 (0%)
Pulmonary fibrosis	2/17 (11.8%)		1/10 (10%)
Skin and subcutaneous tissue disorders
Alopecia	2/17 (11.8%)		1/10 (10%)
Skin fibrosis	1/17 (5.9%)		0/10 (0%)
Skin hyperpigmentation	2/17 (11.8%)		1/10 (10%)

Limitations/Caveats

The study stopped accrual early due to unmet accrual/randomization goals: 81 accrued of 205 planned, 33 randomized of 168 planned. Statistical testing of primary outcome measure not done due to low power.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.