Olaparib and Radiotherapy in Head and Neck Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 24, 2014

Primary Completion Date

January 14, 2020

Study Completion Date

January 31, 2024

Conditions
Laryngeal Cancer Stage IILaryngeal Cancer Stage IIICarcinoma, Squamous CellHead and Neck Neoplasms
Interventions
RADIATION

radiotherapy

Primary tumor and lymph nodes will receive 35 fractions of 2 Gy resulting in a total dose of 70 Gy. Elective fields will receive 35 fractions of 1.55 Gy resulting in a total dose of 54.25 Gy in case a SIB technique is used, or 23 fractions of 2 Gy resulting in a total dose of 46 Gy in case a sequential boost technique is used. The higher total prescribed physical dose to the elective fields in a SIB technique based RT plan compensates for the lower dose per fraction and results in an equal biological effective dose when compared with a sequential boost technique.

DRUG

Olaparib

The pre-defined dose levels of olaparib are 25mg QD, 25, 50, 100, 200, and 300 mg BID

Trial Locations (1)

1066 CX

The Netherlands Cancer Institute, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

The Netherlands Cancer Institute

OTHER