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Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.

NCT02882308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-02-07

No results posted yet for this study

Summary

OPHELIA (OPHELIA (OlaParib and durvalumab in HEad and neck squamous celL carcInomA) trial is a Greek, investigator-initiated, randomized open-label window-of-opportunity phase II study. Patients with operable histologically documented squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx will be randomized between combination with durvalumab and olaparib, cisplatin and olaparib, monotherapy with olaparib or no treatment, before starting standard treatment.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Olaparib

50/25 mg BD split x 5 days

DRUG

Cisplatin

60 mg/m\^2 d1-d5

DRUG

Olaparib

300 mg BD x 21-28 days.

DRUG

Durvalumab

1500 mg d1

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Hellenic Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Diamanto Psyrri, MD,Ass.Prof · Division of Oncology, 2nd Dept of Internal Medicine, University Hospital "Attiko"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-20
Primary Completion
2019-12-31
Completion
2020-01-10

Countries

  • Greece

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02882308 on ClinicalTrials.gov