RADPLAT for maxillary sinus cancer

JRCT ID: jRCTs031180425

Registered date:25/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: maxillary sinus cancer
• Date of first enrollment: 08/03/2013
• Target sample size: 44
• Study type: Interventional
• Intervention(s): Patients with advanced maxillary sinus caner is treated by 4 to 7 times of weekly intra-arterial infusion of cisplatin (120mg/m2) and concurrent radiation therapy using 4-6 MV Linac X-ray of total dose of 60-70Gy(1.8-2.0Gy/ fraction). IMRT can be used in this protocol.

Outcome(s)

• Primary Outcome: Local control rate
• Secondary Outcome: Primary response, adverse events, 0ver all survival, Relapse-free survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1.Maxillary sinus cancer pathologically proved as squamous cell carcinoma
2.Maxillary sinus cancer staged as T3 and T4 on UICC, 2009.
3.No metastatic lymph node
4.Primary treatment case
5.Measurable disease
6.Cather accessible case into the feeding arteries, including internal maxillary artery, facial artery and transverse facial artery.
7.Pursuing of non-surgical and organ-preserving treatment, but salvage surgery for residual cancer can be done.
8.Age of the patient: >=20 y.o. and <=75 y.o.
9.Prognosis better than 8 months
10. ECOG Performance status (PS) 0 or 1

Exclude criteria

1)Bone suppression state
2)Severe infection in the head and neck region
3)Severe systemic complication, such as intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, uncontrolled DM, heart failure, renal failure, and liver failure.
4)Synchronized active cancer
5)History of irradiation for head and neck region
6)History of allergy for cisplatin or contrast medium
7)Severe mental disorder
8)Pregnant, unwell to practice contraception during the study or lactating female
9)Preoperative therapy for planed surgery
10)Inaccessible catheterization due to arteriosclerosis
11)Other causes judged unpreferable by attending physician for this protocol treatment

Related Information

• Primary Sponsor: Tanaka Norimitsu
• Secondary Sponsor: Sone Miyuki
• Secondary ID(s): JIVROS-G 0808