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Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT00057785
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : October 13, 2014
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head and Neck Cancer
Oral Complications of Radiation Therapy
Radiation Toxicity
Interventions Drug: cisplatin
Drug: fluorouracil
Radiation: Intensity modulated radiation therapy
Enrollment 68

Recruitment Details  
Pre-assignment Details  
Arm/Group Title IMRT +/- Chemotherapy
Hide Arm/Group Description Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Period Title: Overall Study
Started 68
Completed 68 [1]
Not Completed 0
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title IMRT +/- Chemotherapy
Hide Arm/Group Description Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
All eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants
48.5
(18 to 73)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
17
  25.0%
Male
51
  75.0%
1.Primary Outcome
Title Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
Hide Description Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.
Time Frame From start of treatment to end of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
First 57 eligible patients who started study treatment.
Arm/Group Title IMRT +/- Chemotherapy
Hide Arm/Group Description:
Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
9
2.Secondary Outcome
Title Rate of Xerostomia at 1 Year (Grade ≥ 2)
Hide Description [Not Specified]
Time Frame From start of treatment to 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Rate of Locoregional Control at 2 Years
Hide Description [Not Specified]
Time Frame From registration to 2 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Whole Mouth Saliva Output Relative to Pretreatment Measurements
Hide Description [Not Specified]
Time Frame From start of treatment to 1 year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Other Acute and Late Toxicities
Hide Description [Not Specified]
Time Frame From start of treatment to last follow-up
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Chemotherapy Compliance
Hide Description [Not Specified]
Time Frame From start of treatment to end of treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 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 nonserious adverse events (AE).
 
Arm/Group Title IMRT +/- Chemotherapy
Hide Arm/Group Description Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
All-Cause Mortality
IMRT +/- Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IMRT +/- Chemotherapy
Affected / at Risk (%)
Total   55/68 (80.88%) 
Blood and lymphatic system disorders   
Febrile neutropenia  3/68 (4.41%) 
Hemoglobin decreased  10/68 (14.71%) 
Packed red blood cell transfusion  4/68 (5.88%) 
Cardiac disorders   
Edema NOS  1/68 (1.47%) 
Left ventricular failure  1/68 (1.47%) 
Sinus tachycardia  1/68 (1.47%) 
Supraventricular arrhythmia NOS  1/68 (1.47%) 
Ventricular arrhythmia NOS  1/68 (1.47%) 
Ear and labyrinth disorders   
Hearing impaired  8/68 (11.76%) 
Hearing-Other  3/68 (4.41%) 
Otitis externa (exc boil of meatus) NOS  2/68 (2.94%) 
Endocrine disorders   
Endocrine-Other  2/68 (2.94%) 
Hypothyroidism  1/68 (1.47%) 
Gastrointestinal disorders   
Diarrhea NOS  1/68 (1.47%) 
Dry mouth  1  3/68 (4.41%) 
Dysphagia  16/68 (23.53%) 
Esophageal spasm  6/68 (8.82%) 
Esophagitis NOS  13/68 (19.12%) 
Nausea  21/68 (30.88%) 
Radiation mucositis  28/68 (41.18%) 
Salivary gland disorder NOS  1  1/68 (1.47%) 
Stomatitis  6/68 (8.82%) 
Vomiting NOS  19/68 (27.94%) 
General disorders   
Fatigue  6/68 (8.82%) 
Pain due to radiation  6/68 (8.82%) 
Pain-other  6/68 (8.82%) 
Pyrexia  1/68 (1.47%) 
Infections and infestations   
Implant infection  1/68 (1.47%) 
Infection NOS  3/68 (4.41%) 
Infection with grade 3 or 4 neutropenia  4/68 (5.88%) 
Infection with unknown ANC  1/68 (1.47%) 
Infection, Other  2/68 (2.94%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS  6/68 (8.82%) 
Investigations   
Alanine aminotransferase increased  1/68 (1.47%) 
Aspartate aminotransferase increased  1/68 (1.47%) 
Blood creatinine increased  1/68 (1.47%) 
CD4 lymphocytes decreased  1/68 (1.47%) 
Inappropriate ADH secretion  1/68 (1.47%) 
Leukocytes for BMT  1/68 (1.47%) 
Leukopenia NOS  4/68 (5.88%) 
Lymphopenia  11/68 (16.18%) 
Neutropenia  20/68 (29.41%) 
Platelet count decreased  4/68 (5.88%) 
Weight decreased  12/68 (17.65%) 
Weight increased  1/68 (1.47%) 
Metabolism and nutrition disorders   
Acidosis NOS  1/68 (1.47%) 
Anorexia  7/68 (10.29%) 
Blood albumin decreased  2/68 (2.94%) 
Blood magnesium decreased  2/68 (2.94%) 
Dehydration  11/68 (16.18%) 
Hyperglycemia NOS  4/68 (5.88%) 
Hyperkalemia  1/68 (1.47%) 
Hypocalcemia  5/68 (7.35%) 
Hypokalemia  8/68 (11.76%) 
Hyponatremia  12/68 (17.65%) 
Hypophosphatemia  2/68 (2.94%) 
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone-Other  1/68 (1.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain  1/68 (1.47%) 
Nervous system disorders   
Headache NOS  1/68 (1.47%) 
Neurologic-Other  1/68 (1.47%) 
Peripheral motor neuropathy  1/68 (1.47%) 
Peripheral sensory neuropathy  1/68 (1.47%) 
Syncope  3/68 (4.41%) 
Psychiatric disorders   
Anxiety NEC  1/68 (1.47%) 
Depression NEC  1/68 (1.47%) 
Hallucination NOS  2/68 (2.94%) 
Renal and urinary disorders   
Renal failure NOS  1/68 (1.47%) 
Renal/GU-Other  2/68 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea NOS  1/68 (1.47%) 
Hypoxia  3/68 (4.41%) 
Pneumonitis NOS  3/68 (4.41%) 
Pulmonary-other  1/68 (1.47%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme  1/68 (1.47%) 
Skin-Other  2/68 (2.94%) 
Vascular disorders   
Hemorrhage NOS  1/68 (1.47%) 
Hypotension NOS  6/68 (8.82%) 
Thrombosis NOS  1/68 (1.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IMRT +/- Chemotherapy
Affected / at Risk (%)
Total   68/68 (100.00%) 
Blood and lymphatic system disorders   
Hematologic-Other  8/68 (11.76%) 
Hemoglobin decreased  51/68 (75.00%) 
Cardiac disorders   
Edema NOS  13/68 (19.12%) 
Ear and labyrinth disorders   
Earache  4/68 (5.88%) 
Hearing impaired  33/68 (48.53%) 
Hearing-Other  17/68 (25.00%) 
Late RT toxicity: Auditory/hearing: NOS  2  32/68 (47.06%) 
Otitis media serous NOS  7/68 (10.29%) 
Endocrine disorders   
Hypothyroidism  10/68 (14.71%) 
Gastrointestinal disorders   
Constipation  14/68 (20.59%) 
Diarrhea NOS  9/68 (13.24%) 
Dry mouth  1  61/68 (89.71%) 
Dysphagia  24/68 (35.29%) 
Esophagitis NOS  28/68 (41.18%) 
GI-other  8/68 (11.76%) 
Late RT toxicity: Esophagus: NOS  2  28/68 (41.18%) 
Late RT toxicity: Larynx: NOS  2  13/68 (19.12%) 
Late RT toxicity: Mucous membrane: NOS  2  41/68 (60.29%) 
Late RT toxicity: Salivary gland: NOS  2  51/68 (75.00%) 
Nausea  46/68 (67.65%) 
Radiation mucositis  50/68 (73.53%) 
Salivary gland disorder NOS  1  59/68 (86.76%) 
Stomatitis  15/68 (22.06%) 
Vomiting NOS  31/68 (45.59%) 
General disorders   
Fatigue  50/68 (73.53%) 
Late RT toxicity: Other: NOS  2  33/68 (48.53%) 
Pain due to radiation  24/68 (35.29%) 
Pain-other  24/68 (35.29%) 
Pyrexia  10/68 (14.71%) 
Rigors  5/68 (7.35%) 
Infections and infestations   
Infection NOS  7/68 (10.29%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS  43/68 (63.24%) 
Late RT toxicity: Skin (within RT field): NOS  2  22/68 (32.35%) 
Late RT toxicity: Subcutaneous tissue (within RT field): NOS  2  27/68 (39.71%) 
Investigations   
Alanine aminotransferase increased  13/68 (19.12%) 
Aspartate aminotransferase increased  9/68 (13.24%) 
Blood alkaline phosphatase NOS increased  9/68 (13.24%) 
Blood bilirubin increased  6/68 (8.82%) 
Blood creatinine increased  12/68 (17.65%) 
Gamma-glutamyltransferase increased  5/68 (7.35%) 
Leukopenia NOS  50/68 (73.53%) 
Lymphopenia  16/68 (23.53%) 
Metabolic-Other  7/68 (10.29%) 
Neutropenia  33/68 (48.53%) 
Platelet count decreased  18/68 (26.47%) 
Weight decreased  40/68 (58.82%) 
Metabolism and nutrition disorders   
Anorexia  18/68 (26.47%) 
Blood albumin decreased  19/68 (27.94%) 
Blood magnesium decreased  15/68 (22.06%) 
Dehydration  19/68 (27.94%) 
Hyperglycemia NOS  16/68 (23.53%) 
Hyperkalemia  7/68 (10.29%) 
Hypocalcemia  17/68 (25.00%) 
Hypokalemia  15/68 (22.06%) 
Hyponatremia  26/68 (38.24%) 
Hypophosphatemia  6/68 (8.82%) 
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone-Other  4/68 (5.88%) 
Late RT toxicity: Bone (incl. osteonecrosis): NOS  2  4/68 (5.88%) 
Late RT toxicity: Joint: NOS  2  13/68 (19.12%) 
Nervous system disorders   
Dizziness (exc vertigo)  4/68 (5.88%) 
Headache NOS  10/68 (14.71%) 
Neuralgia NOS  4/68 (5.88%) 
Peripheral motor neuropathy  6/68 (8.82%) 
Peripheral sensory neuropathy  23/68 (33.82%) 
Taste disturbance  19/68 (27.94%) 
Psychiatric disorders   
Confusion  4/68 (5.88%) 
Insomnia NEC  4/68 (5.88%) 
Renal and urinary disorders   
Renal/GU-Other  13/68 (19.12%) 
Respiratory, thoracic and mediastinal disorders   
Cough  11/68 (16.18%) 
Dysphonia  5/68 (7.35%) 
Dyspnea NOS  6/68 (8.82%) 
Epistaxis  15/68 (22.06%) 
Hiccups  5/68 (7.35%) 
Pulmonary-other  4/68 (5.88%) 
Rhinitis allergic NOS  5/68 (7.35%) 
Skin and subcutaneous tissue disorders   
Alopecia  20/68 (29.41%) 
Dermatitis exfoliative NOS  6/68 (8.82%) 
Erythema multiforme  6/68 (8.82%) 
Skin discoloration  9/68 (13.24%) 
Skin-Other  8/68 (11.76%) 
Toxicoderma  4/68 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00057785     History of Changes
Other Study ID Numbers: RTOG-0225
CDR0000269314
First Submitted: April 7, 2003
First Posted: April 9, 2003
Results First Submitted: October 8, 2014
Results First Posted: October 13, 2014
Last Update Posted: February 17, 2017