The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with esophageal cancer that is locally advanced or has spread to another area of the body (metastasized).
The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with esophageal cancer that is locally advanced or has spread to another area of the body (metastasized). Who is it for? Participant may be eligible for this study if participant is an adult who has cancer of the esophagus or gastro-esophageal junction that is locally advanced or has spread to other parts of the participant's body. Study details All participants in this study will receive 10 treatments of radiotherapy to the primary esophageal cancer, with one treatment given on each working day for two weeks. In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same two weeks as the radiotherapy. Durvalumab, an immune therapy, received intravenously; will be given every four weeks from the beginning of radiation therapy. After this participants will continue to receive immune therapy (durvalumab), received intravenously once every 4 weeks for up to 24 months or until the cancer worsens. If participants have a metastatic tumour, they will also be given 3 doses of radiotherapy in one week. This radiotherapy will be received 4 weeks after the initial radiotherapy is completed. Safety blood tests will be collected throughout the study (every two weeks from week 2 of treatment and then every four weeks from week 9 throughout the treatment and at other times if clinically indicated). CT scans to evaluate the response to treatment will be done every 6 weeks up to week 24 of treatment and then every 12 weeks or until the cancer worsens. Study participants will also be asked to complete some questionnaires about their wellbeing and nutritional status periodically throughout the study. It is hoped that this trial can help determine if this chemotherapy with immune therapy and radiotherapy combination is effective in increasing the ability of the body's immune system to prevent worsening of the cancer and improve swallowing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Durvalumab will be supplied by AstraZeneca as a 500 mg vial concentrate for solution for infusion. The solution contains 50 mg/mL durvalumab, 26 mM histidine/histidine-hydrochloride, 275 mM trehalose dihydrate, and 0.02% weight/volume (w/v) polysorbate 80; it has a pH of 6.0 and density of 1.054 g/mL. The label-claim volume is 10 mL. Durvalumab is a sterile, clear to opalescent, colorless to slightly yellow solution, free from visible particles. Investigational product vials are stored at 2°C to 8°C and must not be frozen. Investigational product must be kept in original packaging until use to prevent prolonged light exposure.
Canberra Hospital
Garran, Australian Capital Territory, Australia
NOT_YET_RECRUITINGBorder Medical Oncology
Albury, New South Wales, Australia
ACTIVE_NOT_RECRUITINGCalvary Mater Newcastle
Newcastle, New South Wales, Australia
Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT scan and clinical review.
The interval from the date of participant registration to the date of a progression free survival event: 1. date of the first CT scan to show disease progression 2. patient is judged to have progressed by the responsible investigator (in the event that no RECIST assessment is available) 3. death occurs.
Time frame: 6 months
Duration of dysphagia relief
Maintenance of Mellow score at least 1 point above baseline. Mellow score may be optionally assessed at days 22, 36 and 50 if the participants attend the clinic for any other unscheduled visit. Mellow score ranges from grade 0-4. Grade 0 indicating no dysphagia and grade 4 indicating inability to swallow.
Time frame: Mellow score will be assessed at days 1, 8, 15, 29, 43, 57 and then every 4 weeks thereafter until the end of treatment visits (30days after the last dose).
Nutritional status
Determined by clinical review and collected from the participant using the scored Patient-generated subjective global assessment (PG\_SGA) tool.
Time frame: To be administered by a qualified dietician from date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 weeks.
Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30
Assessment of European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30
Time frame: Through study completion, an average of 1 year, using the 4-point ordinal scale - not at all, a little, quite a bit and very much
Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18
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Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
RECRUITINGFlinders Medical Centre
Bedford Park, South Australia, Australia
RECRUITINGSt Vincent's Hospital
Fitzroy, Victoria, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGSir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
RECRUITINGAuckland Hospital
Grafton, Auckland, New Zealand
RECRUITINGAssessment of European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18
Time frame: Through study completion, an average of 1 year, using the 4-point ordinal scale - not at all, a little, quite a bit and very much
Response rate in metastatic lesions
Assessed using radiological imaging with Contrast CT Scan (chest and abdomen, + neck)
Time frame: Assessment with imaging scans is performed at baseline then every 6 weeks while in treatment, then every 12 weeks until disease progression or date of death from any cause, whichever came first, assessed up to 96 weeks.
Physician graded toxicity
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: Assessed from baseline to 90 days following last treatment dose.
SAE Rate
Assessed as reported by the participant and by clinician assessment from consent signing to 100 days after last dose of durvalumab regardless of relationship to drug. Adverse events will be documented in the patient medical record. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) results in death, 2) is life-threatening (i.e. the participant is at risk of death at the time of the event), 3) requires inpatient hospitalisation or prolongation of existing hospitalisation, 4) results in persistent or significant disability or incapacity, 5) is a congenital anomaly/birth defect, 6) other important medical events which may jeopardize the patient or may require intervention to prevent one of the listed outcomes in the definition above, which, in the opinion of the Investigator, are likely to become serious if untreated.
Time frame: Days 1, 8, 15, 29, 43, 57 and then every 4 weeks thereafter until to 100 days after last dose durvalumab regardless of relationship to drug.
Overall survival.
Overall survival will be reported with Kaplan Meier curves and summarized by their medians, and proportions event-free
Time frame: Throughout study completion, average 2 years