Status:
TERMINATED
Dose Escalated Adaptive RadioTherapy in Definitive Chemo-radiotherapy for Esophageal Cancer
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital Skejby
Rigshospitalet, Denmark
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In Denmark, 1000 new cases of esophageal and gastro-esophageal junction cancer occur every year. Surgery is the primary treatment for patients with localized disease who are considered medically and t...
Detailed Description
In Denmark, there are almost 900 new cases of oesphageal and gastro-esophageal junction (GEJ) cancer per year, with a 5-year survival rate below 20% for the entire group and a 5-year survival rate of ...
Eligibility Criteria
Inclusion
- The patients must meet all of the following inclusion criteria to be included in the study:
- Patients with histologically verified squamous cell or adenocarcinoma (including signet cell carcinoma) of the oesophagus or GEJ.
- Multi-Disciplinary Team (MDT) assessment and treatment recommendation; deemed nonresectable and/or inoperable.
- TNM stage (8th edition): cT1-4a or cN+, cM0-1 (M1 disease limited to metastatic lymph nodes)
- Age ≥18 years.
- Performance status ≤2.
- Adequate cardiac, lung and renal function measured according to local guidelines.
- Adequate laboratory findings:
- haematological: haemoglobin \> 90 g/L, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L
- hepatic: bilirubin ≤ 1.5 x ULN, ALAT ≤ 3 x ULN
- renal: creatinine ≤ 1.5 x ULN
- Suitability to undergo curatively intended chemoradiation therapy.
- Ability to adhere to procedures for study and follow-up.
- Women must present a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use oral contraceptives, intrauterine devices, depot injection of progestin subdermal implantation, a hormonal vaginal ring, or transdermal patch during the study treatment and one month after.
- Signed informed consent to participate in the study, including acceptance that dose plan and scans will be stored in a national dose plan bank, and the remaining data stored in a central database.
- A standard plan for radiotherapy with homogenous 50 Gy / 25 fractions, meeting all dose constraints for normal tissue, must be achievable.
Exclusion
- Patients who will meet one or more of the following exclusion criteria cannot be included in this study:
- Prior oncological treatment or surgical resection for the present disease
- Broncho-pulmonary fistula verified by bronchoscopy
- Any other active malignancies which may compromise study protocol or endpoints except for basal or squamous cell skin cancer
- Any unstable systemic disease (including clinically significant cardiovascular disease, unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart, severe hepatic, renal or metabolic disease or active inflammatory bowel disease)
- Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)
- Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
- Severely decreased lung function
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04086901
Start Date
January 1 2020
End Date
March 1 2021
Last Update
March 9 2021
Active Locations (3)
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1
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
2
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200
3
Odense Universityhospital
Odense, Fyn, Denmark, 5000