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Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00068237
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : January 31, 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: Supportive Care
Conditions Head and Neck Cancer
Radiation Toxicity
Xerostomia
Interventions Procedure: Surgery for the primary and neck nodes
Procedure: Submandibular salivary gland transfer
Radiation: Post-operative radiation therapy
Enrollment 49

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surgery and Salivary Gland Transfer and Radiation
Hide Arm/Group Description Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
Period Title: Overall Study
Started 49
Completed 44 [1]
Not Completed 5
Reason Not Completed
Ineligible             3
No protocol treatment received             2
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Surgery and Salivary Gland Transfer and Radiation
Hide Arm/Group Description Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
All eligible patients who started study treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
56.5
(42 to 74)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
8
  18.2%
Male
36
  81.8%
1.Primary Outcome
Title Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
Hide Description Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.
Time Frame At the time of the submandibular salivary gland transfer
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment.
Arm/Group Title Surgery and Salivary Gland Transfer and Radiation
Hide Arm/Group Description:
Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: participants
34
2.Secondary Outcome
Title Rate of Acute Xerostomia
Hide Description [Not Specified]
Time Frame From start of treatment to 90 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Salivary Scan Evaluation
Hide Description [Not Specified]
Time Frame From start of treatment to 6 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Quality of Life
Hide Description [Not Specified]
Time Frame From registration to 1 year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Toxicity
Hide Description [Not Specified]
Time Frame From start of treatment to last follow-up
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Disease-free Survival
Hide Description [Not Specified]
Time Frame From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame From registration to date of death or last follow-up
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specfic adverse events due to the timing and sequence of treatments.
 
Arm/Group Title Surgery and Salivary Gland Transfer and Radiation
Hide Arm/Group Description Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
All-Cause Mortality
Surgery and Salivary Gland Transfer and Radiation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Surgery and Salivary Gland Transfer and Radiation
Affected / at Risk (%)
Total   2/44 (4.55%) 
Metabolism and nutrition disorders   
Anorexia * 1  1/43 (2.33%) 
Psychiatric disorders   
Confusion * 1  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders   
Apnoea * 1  1/43 (2.33%) 
Surgical and medical procedures   
Acute Surgical Complication: Bleeding/hematoma   2/44 (4.55%) 
Acute Surgical Complication: Cerebral embolism/CVA   1/44 (2.27%) 
Acute Surgical Complication: Wound infection   2/44 (4.55%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surgery and Salivary Gland Transfer and Radiation
Affected / at Risk (%)
Total   38/44 (86.36%) 
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  4/43 (9.30%) 
Lymphatics-Other * 1  1/43 (2.33%) 
Ear and labyrinth disorders   
Hearing impaired * 1  2/43 (4.65%) 
Hearing-Other * 1  3/43 (6.98%) 
Endocrine disorders   
Hypothyroidism * 1  1/43 (2.33%) 
Gastrointestinal disorders   
Constipation * 1  2/43 (4.65%) 
Diarrhea NOS * 1  2/43 (4.65%) 
Dry mouth  1  26/43 (60.47%) 
Dysphagia * 1  6/43 (13.95%) 
Esophageal spasm * 1  1/43 (2.33%) 
Esophagitis NOS * 1  6/43 (13.95%) 
GI-other * 1  3/43 (6.98%) 
Gastric ulcer * 1  1/43 (2.33%) 
Nausea * 1  10/43 (23.26%) 
Radiation mucositis * 1  14/43 (32.56%) 
Salivary gland disorder NOS  1  18/43 (41.86%) 
Stomatitis * 1  3/43 (6.98%) 
Vomiting NOS * 1  7/43 (16.28%) 
General disorders   
Chest pain * 1  1/43 (2.33%) 
Fatigue * 1  17/43 (39.53%) 
Infection NOS * 1  1/43 (2.33%) 
Late RT Toxicity: Esophagus  2  4/38 (10.53%) 
Late RT Toxicity: Joint  2  3/38 (7.89%) 
Late RT Toxicity: Larynx  2  6/38 (15.79%) 
Late RT Toxicity: Mucous Membrane  2  9/38 (23.68%) 
Late RT Toxicity: Other  2  10/38 (26.32%) 
Late RT Toxicity: Salivary Gland (xerostomia, taste impairme  2  22/38 (57.89%) 
Late RT Toxicity: Skin (within XRT field)  2  6/38 (15.79%) 
Late RT Toxicity: Subcutaneous Tissue (Within XRT field)  2  6/38 (15.79%) 
Pain due to radiation * 1  11/43 (25.58%) 
Pain-other * 1  8/43 (18.60%) 
Pyrexia * 1  2/43 (4.65%) 
Rigors * 1  1/43 (2.33%) 
Immune system disorders   
Allergy-Other * 1  1/43 (2.33%) 
Infections and infestations   
Infection, Other * 1  5/43 (11.63%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS * 1  12/43 (27.91%) 
Investigations   
Blood creatinine increased * 1  1/43 (2.33%) 
Leukopenia NOS * 1  3/43 (6.98%) 
Weight decreased * 1  12/43 (27.91%) 
Metabolism and nutrition disorders   
Anorexia * 1  7/43 (16.28%) 
Blood albumin decreased * 1  1/43 (2.33%) 
Blood magnesium decreased * 1  1/43 (2.33%) 
Dehydration * 1  5/43 (11.63%) 
Hypokalemia * 1  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone-Other * 1  5/43 (11.63%) 
Muscle weakness NOS * 1  1/43 (2.33%) 
Nervous system disorders   
Depressed level of consciousness * 1  1/43 (2.33%) 
Peripheral motor neuropathy * 1  1/43 (2.33%) 
Peripheral sensory neuropathy * 1  1/43 (2.33%) 
Taste disturbance  1  23/43 (53.49%) 
Psychiatric disorders   
Anxiety NEC * 1  2/43 (4.65%) 
Insomnia NEC * 1  2/43 (4.65%) 
Reproductive system and breast disorders   
Sexual/reproductive function-Other * 1  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  5/43 (11.63%) 
Dysphonia * 1  2/43 (4.65%) 
Dyspnea NOS * 1  5/43 (11.63%) 
Hemoptysis * 1  2/43 (4.65%) 
Hypoxia * 1  1/43 (2.33%) 
Pulmonary-other * 1  2/43 (4.65%) 
Skin and subcutaneous tissue disorders   
Dermatitis exfoliative NOS * 1  6/43 (13.95%) 
Erythema multiforme * 1  1/43 (2.33%) 
Skin discoloration * 1  1/43 (2.33%) 
Skin-Other * 1  2/43 (4.65%) 
Surgical and medical procedures   
Acute Surgical Complication: Facial edema   6/44 (13.64%) 
Acute Surgical Complication: Facial edema on the transfer si   6/44 (13.64%) 
Acute Surgical Complication: Gland movement out of position   1/44 (2.27%) 
Acute Surgical Complication: Neck numbness   3/44 (6.82%) 
Acute Surgical Complication: Neck numbness on the transfer s   2/44 (4.55%) 
Acute Surgical Complication: Nerve injury: hypoglossal   1/44 (2.27%) 
Acute Surgical Complication: Nerve injury: hypoglossal on th   1/44 (2.27%) 
Acute Surgical Complication: Nerve injury: lingual   1/44 (2.27%) 
Acute Surgical Complication: Other   4/44 (9.09%) 
Acute Surgical Complication: Shoulder weakness   2/44 (4.55%) 
Acute Surgical Complication: Shoulder weakness on the transf   1/44 (2.27%) 
Late Surgical Complication: Other   10/44 (22.73%) 
Late Surgical Complication: Recurrent adenitis   1/44 (2.27%) 
Late Surgical Complication: Submental fullness   8/44 (18.18%) 
Vascular disorders   
Edema NOS * 1  3/43 (6.98%) 
Hemorrhage-Other * 1  1/43 (2.33%) 
Lymphangiopathy NOS * 1  2/43 (4.65%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (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 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.
Results Point of Contact
Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00068237     History of Changes
Other Study ID Numbers: RTOG-0244
CDR0000287213
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: October 29, 2013
Results First Posted: January 31, 2014
Last Update Posted: February 17, 2017