A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
Collecte de données
Néoplasmes de la tête et du cou+4
+ Maladies de la bouche
+ Maladies stomatognathiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Compare the proportion of patients with oropharyngeal or hypopharyngeal cancer with xerostomia of ≥ grade 2 at one year after treatment with parotid-sparing intensity-modulated radiotherapy vs conventional radiotherapy. Secondary * Compare the degree of xerostomia by quantitative measurements of stimulated and unstimulated salivary flow in patients treated with these regimens. * Compare quality of life in patients treated with these regimens. * Compare local and regional tumor control, time to tumor progression, and overall survival of patients treated with these regimens. * Compare acute and late side effects of these regimens in these patients. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and site of disease (oropharynx vs hypopharynx). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo parotid-sparing intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. * Arm II: Patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks. Salivary flow measurements are performed at baseline, at week 4 during radiotherapy, and then at 2 weeks and at 3, 6, 12, and 24 months after the completion of radiotherapy. Quality of life is assessed at baseline, at 2 weeks, and then at 3, 6, 12, 18, and 24 months after the completion of radiotherapy. Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.84 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically confirmed oropharyngeal or hypopharyngeal cancer * Squamous cell or undifferentiated carcinoma * Stage T1-4, N0-3, M0 disease * Primary tumor requiring radical radiotherapy with parallel opposed lateral fields and bilateral cervical lymph node irradiation * Radiotherapy is either the primary therapy or post-operative (adjuvant irradiation) treatment * High-risk for radiation-induced xerostomia with conventional radiotherapy due to irradiation of the majority of both parotid glands\* NOTE: \*Estimated mean dose to both parotid glands is greater than 24 Gy by conventional radiotherapy * No bilateral N3 nodal disease * No huge primary tumor (exceeding 10 cm in diameter) * No contralateral lymphadenopathy adjacent to or involving contralateral parotid gland making parotid sparing impossible * No tumor at the base of the tongue where sparing of contralateral parapharyngeal space is contraindicated PATIENT CHARACTERISTICS: Age * Not specified Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Able to undergo quality of life and salivary flow measurements (dependent on cognitive aptitude and long availability) * Able to complete self-assessed quality of life questionnaire * No prior or concurrent illness that would preclude study participation * No pre-existing salivary gland pathology interfering with saliva production * No other prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior neoadjuvant chemotherapy allowed * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy to the head and neck region * No concurrent brachytherapy Surgery * See Disease Characteristics Other * No concurrent prophylactic amifostine or pilocarpine
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 9 sites
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, United KingdomIpswich Hospital
Ipswich, United KingdomBarts and the London School of Medicine
London, United Kingdom