Clinical trial · Interventional
Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
A Phase II Study Of Submandibular Salivary Gland Transfer To The Submental Space Prior To Start Of Radiation Treatment For Prevention Of Radiation-Induced Xerostomia In Head And Neck Cancer Patients
NCT00068237CI-TRIAL-00036943completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation Toxicity | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative radiation therapy | Radiation | — | UNRESOLVED |
| salivary gland transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery + Transfer + Radiation
- description
- Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
- interventionNames
- Procedure: salivary gland transfer
- Radiation: Post-operative radiation therapy
Primary outcomes (1)
- measure
- Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
- timeFrame
- At the time of the submandibular salivary gland transfer
- 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%.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTJha N, Harris J, Seikaly H, Jacobs JR, McEwan AJ, Robbins KT, Grecula J, Sharma AK, Ang KK. A phase II study of submandibular gland transfer prior to radiation for prevention of radiation-induced xerostomia in head-and-neck cancer (RTOG 0244). Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):437-42. doi: 10.1016/j.ijrobp.2012.02.034. Epub 2012 Apr 27. PMID 22541957