Phase 2
Completed N=49
Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
Head and Neck Cancer · Radiation Toxicity · xerostomia
Source: ClinicalTrials.gov NCT00068237 ↗
Enrolled (actual)
49
Serious AEs
4.6%
Results posted
Jan 2014
Primary outcomePrimary: Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" — 34 participants
Summary
RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth).
PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" |
34 | — |
| SECONDARY Percentage of Patients With Acute Xerostomia |
25.6 | — |
| SECONDARY Percentage of Patients With Normal Functioning Transferred Submandibular Gland |
70.3; 16.7; 0.0 | — |
| SECONDARY Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire |
13.6 | — |
| SECONDARY Percentage of Patients Experiencing Facial Edema Following Surgery |
13.6 | — |
| SECONDARY Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy |
34.9 | — |
| SECONDARY Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy |
7.9 | — |
| SECONDARY Disease-free Survival Rate at 2 Years |
71.7 | — |
| SECONDARY Overall Survival Rate at 2 Years |
76.4 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- One of the following diagnoses:
- Histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- Head and neck cancer of unknown primary with unilateral metastases to the neck nodes
- No N3 disease
- No carcinoma of the oral cavity or nasopharynx
- No bilateral neck node involvement
- No suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by CT scan or MRI
- No pre-epiglottic space involvement
- No involvement of level 1 nodes on either side of the neck
- No salivary gland malignancy
- No recurrent disease
PATIENT CHARACTERISTICS:
Age
- At least 18 years old
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin at least 10 g/dL
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No salivary gland disease (e.g., Sjögren's syndrome)
- No other malignancy within the past 3 years except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 3 years since prior chemotherapy
- No prior or concurrent neoadjuvant chemotherapy
- Concurrent adjuvant chemoradiotherapy (in addition to study radiotherapy) allowed
Endocrine therapy
- Not specified
Radiotherapy
- See Chemotherapy
- No prior radiotherapy to the head and neck
- No concurrent intensity-modulated radiotherapy
Surgery
- Not specified
Other
- No concurrent cholinergic drugs
- No concurrent anti-cholinergic drugs
- No concurrent tricyclic drugs
- No concurrent prophylactic amifostine or pilocarpine during and for at least 3 months after completion of study radiotherapy
Data sourced from ClinicalTrials.gov (NCT00068237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.