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Carcinoma of the OesophagusPhase 1ROCOCONCT01460888

Radiotherapy & Olaparib in COmbination for Carcinoma of the Oesophagus

A Phase 1 study testing Olaparib and Radical external beam radiotherapy, 50Gy in 25 fractions in people with Carcinoma of the Oesophagus, run by The Christie NHS Foundation Trust at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma of the Oesophagus
What is being tested?
Olaparib and Radical external beam radiotherapy, 50Gy in 25 fractions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesUnited Kingdom
Study dates
Jul 2013to Aug 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

Ian Emerson, Mr contact

+44 (0)161 918 7443

ian.emerson@christie.nhs.uk

United Kingdom2 sites, 2 recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Hamid Shiekh, Dr

    Not yet recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Andrew Jackson, MD, +44(0)2380795386, Andrew.Jackson@uhs.nhs.uk

    Andrew Jackson, Dr

    Recruiting

Other trials in United Kingdom

About this study

Official title: Radiotherapy & Olaparib in COmbination for Carcinoma of the Oesophagus. A Phase I Trial.

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.

Being tested
Olaparib, Radical external beam radiotherapy, 50Gy in 25 fractions
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    25mg tablets, oral. Commenced 3 days prior to radiotherapy and continuing until the last day of radiotherapy (36 days in total).

  • Radical external beam radiotherapy, 50Gy in 25 fractionsRadiation

    Radiotherapy to the oesophageal carcinoma. For patients receiving olaparib this is delivered as 50Gy in 25 daily fractions for 5 weeks (Monday-Friday only). For patients in the comparator arm (RT only) other total doses/ fractionation are permitted, according to local policy/ best standard care.

Study groups in NCT01460888
Study groupRoleWhat they receive
OLA-0 (de-escalation dose)Experimental25mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
Receives: Drug: Olaparib; Radiation: Radical external beam radiotherapy, 50Gy in 25 fractions
OLA-1Experimental50mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
Receives: Drug: Olaparib; Radiation: Radical external beam radiotherapy, 50Gy in 25 fractions
OLA-2Experimental100mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
Receives: Drug: Olaparib; Radiation: Radical external beam radiotherapy, 50Gy in 25 fractions
OLA-3Experimental200mg olaparib twice daily + radiotherapy (50Gy in 25 fractions)
Receives: Drug: Olaparib; Radiation: Radical external beam radiotherapy, 50Gy in 25 fractions
RT aloneActive comparatorNot described
Receives: Radiation: Radical external beam radiotherapy, 50Gy in 25 fractions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of olaparib in combination with radical radiotherapy in patients with oesophageal cancer

    MTD will be determined by the number of patients experiencing dose limiting toxicities (DLTs) in each treatment cohort, using a 3+3 dose escalation schedule. A DLT is determined as grade 4 oesophagitis or dysphagia, or any other grade 3 toxicity. DLTs will be assessed weekly during treatment (day -3 to week 5), 10-14 days after completing treatment, weekly for a further 3 weeks and 3 months after completing treatment.

    Measured: 3 months post treatment

Secondary outcomes (5)

  1. Overall toxicity profile of treatment (NCRI Common Toxicity Criteria for Adverse Effects V3)

    Toxicity of treatment will be assessed via collection of adverse events, categorised by the NCRI Common Toxicity Criteria for Adverse Effects (CTCAE) V3. Adverse event data will be collected continuously from screening, with patients seen weekly during their treatment, 10-14 days after treatment completion, weekly for 3 further weeks, 3 monthly until 1 year then 6 monthly until 3 years.

    Measured: Assessed at all study visits, up to 3 years post treatment.

  2. Olaparib compliance

    Measured: At completion of olaparib treatment (end of week 5)

  3. Radiotherapy (RT) compliance

    Measured: At completion of RT treatment (end of week 5)

  4. Local and overall treatment failure rate

    This is defined as residual disease pathologically on endoscopic assessment \& biopsy or progressive disease on CT scan of thorax and abdomen.

    Measured: 3 months

  5. Exploration of blood and tissue borne pharmacodynamic markers to establish the biological efficacy of the addition of Olaparib to radiotherapy.

    • Endoscopic biopsy sample taken for analysis at screening \& 3 months post treatment
    • Translational research blood samples taken at screening, weekly during treatment, at end of treatment visit \& 3 months after treatment
    • Skin biopsy samples taken from within \& outside irradiated field at week 4

    Measured: Up to 3 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2011 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2015 (estimated)
  4. Study completionAug 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460888
Sponsor's protocol ID
10_DOG03_194
Acronym
ROCOCO
Status last verified
Dec 2011
First submitted
25 Oct 2011
Last updated
19 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Olaparib and Radical external beam radiotherapy, 50Gy in 25 fractions in people with Carcinoma of the Oesophagus, run by The Christie NHS Foundation Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ian Emerson, Mr (+44 (0)161 918 7443, ian.emerson@christie.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of olaparib in combination with radical radiotherapy in patients with oesophageal cancer (time frame: 3 months post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01460888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2013.

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