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RADPLAT for maxillary sinus cancer

Phase II study of radiation with concomitant intra-arterial cisplatin infusion chemotherapy for maxillary sinus cancer - Phase II study of RADPLAT for maxillary sinus cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180425
Enrollment
44
Registered
2019-03-25
Start date
2019-03-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

maxillary sinus cancer maxillary sinus cancer, head and neck cancer

Interventions

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 dos
D010478
intraarterial chemotherapy, RADPLAT, cisplatin

Sponsors

Tanaka Norimitsu
Lead Sponsor
Sone Miyuki
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Local control rate

Secondary

MeasureTime frame
Primary response, adverse events, 0ver all survival, Relapse-free survival

Contacts

Public ContactNorimitsu Tanaka

Kurume University Hospital

nori@med.kurume-u.ac.jp+81-942-31-7576

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026