Clinical trial · Interventional
Dose Escalated Adaptive RadioTherapy in Definitive Chemo-radiotherapy for Esophageal Cancer
Dose Escalated Adaptive RadioTherapy - a Randomised Phase II Study of Definitive Chemo-radiotherapy in Locally Advanced Esophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): New data show no effect of dose escalation and also poor recruitment
Summary
Brief summary (as posted)
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 technically operable. For patients deemed non-resectable, definitive chemoradiotherapy is the treatment of choice, but despite treatment with curative intent, these patients have a poor prognosis, with a median survival of less than 20 months and a 5-year survival at 15-25% in clinical studies This study will examine the effect of escalation of increasing the radiation dose to the most Positron Emissions Tomografi (PET) avid part of the tumour and lymph nodes compared to a standard uniform dose distribution.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy dose escalation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation Arm
- description
- Chemo-radiotherapy with radiotherapy dose escalation based on Flour-Deoxy-Glucose /Positron Emissions Tomografi (FDG/PET) scans
- interventionNames
- Radiation: Radiotherapy dose escalation
- type
- NO_INTERVENTION
- label
- Standard
- description
- Standard chemo-radiotherapy
Primary outcomes (1)
- measure
- Loco-regional control
- timeFrame
- 12 months
- description
- Loco-regional control evaluated with Flour-Deoxy-Glucose /Positron Emissions Tomografi (FDG-PET)
Secondary outcomes (17)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: 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
References
Publications (1)
- DERIVEDSakanaka K, Ishida Y, Fujii K, Ishihara Y, Nakamura M, Hiraoka M, Mizowaki T. Radiation Dose-escalated Chemoradiotherapy Using Simultaneous Integrated Boost Intensity-Modulated Radiotherapy for Locally Advanced Unresectable Thoracic Oesophageal Squamous Cell Carcinoma: A Single-institution Phase I Study. Clin Oncol (R Coll Radiol). 2021 Mar;33(3):191-201. doi: 10.1016/j.clon.2020.07.012. Epub 2020 Aug 4. PMID 32768158