Radiotherapy & Olaparib in COmbination for Carcinoma of the Oesophagus

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    The Christie NHS Foundation Trust
Updated on 8 November 2020
platelet count
cancer
squamous cell carcinoma
chemoradiotherapy
neutrophil count
adenocarcinoma
esophagus cancer
oesophageal stent

Summary

The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of olaparib in combination with radical radiotherapy in patients with oesophageal cancer who are unsuitable for platinum containing chemotherapy.

Details
Condition Carcinoma of the Oesophagus
Treatment olaparib, Radical external beam radiotherapy, 50Gy in 25 fractions
Clinical Study IdentifierNCT01460888
SponsorThe Christie NHS Foundation Trust
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Carcinoma of the Oesophagus?
Histologically confirmed adenocarcinoma or squamous cell carcinoma of the oesophagus including Siewert type 1 or 2 tumours with 2cm gastric mucosal extension
Unsuitable for radical chemoradiation therapy but suitable for radiotherapy
Total length of tumour and involved lymph nodes 10cm
No oesophageal stent in situ
No previous chemotherapy or radiotherapy for oesophagus cancer
Disease which can be encompassed within a radical radiotherapy treatment volume
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (see ECOG criteria appendix 1)
Provision of fully informed consent, signed, written and dated, prior to any study specific procedures
> 18 years of age
Adequate organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below
Haemoglobin 10.0 g/dL
Absolute neutrophil count (ANC) 1.5 x 109/L
White blood cells (WBC) > 3 x 109/L
Platelet count 100 x 109/L
No dysplastic features on peripheral blood smear
Total bilirubin 1.5 x institutional upper limit of normal
Aspartate aminotransferase (AST(SGOT)/Alanine transaminase (ALT)SGPT) 2.5 x institutional upper limit of normal
Serum creatinine 1.5 x institutional upper limit of normal (ULN)
Adequate lung function: no history of interstitial lung disease and FEV1 > 1litre and >30% predicted
Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Postmenopausal is defined as
Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
Luteinizing hormone(LH) and Follicle-stimulating hormone (FSH) levels in the post menopausal range for women under 50
radiation-induced oophorectomy with last menses >1 year ago
chemotherapy-induced menopause with >1 year interval since last menses
surgical sterilisation (bilateral oophorectomy or hysterectomy)
Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Fit to receive all study treatments
Swallowing sufficiently good to tolerate oral medication
Life expectancy 4 months

Exclusion Criteria

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Previous enrolment in the present study
Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
Any previous treatment with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, including olaparib
Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for 5 years
Patients receiving the following classes of inhibitors of cytochrome P450 3A4 (CYP3A4)
Azole antifungals
Macrolide antibiotics
Protease inhibitors
Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, or any psychiatric disorder that prohibits obtaining informed consent
Patients with a history of interstitial lung disease, inflammatory lung conditions, or severe chronic obstructive pulmonary disease (COPD) (FEV1<1litre or < 30% predicted). Patients with pneumonia within the previous 3 months
Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
Patients with oesophageal stent in-situ
Patients with myelodysplastic syndrome/acute myeloid leukaemia
Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
Patients with known active hepatic disease (i.e., Hepatitis B or C)
Patients with a known hypersensitivity to olaparib or any of the excipients of the product
Patients with uncontrolled seizures
Concurrent uncontrolled medical illness, or other previous or current malignant disease likely to interfere with protocol treatments / comparisons
Age < 18
Any pregnant, lactating women or potentially childbearing patients not using adequate contraception (see section 3.4 for details of required contraception)
Previous chemotherapy or radiotherapy for oesophageal cancer
Metastatic disease apart from local lymph node disease which can be reasonably encompassed within the radiotherapy volume (total length of tumour and lymph node disease should be <10cm)
ECOG performance status >2
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