Clinical trial · Observational
Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite multimodal therapy, patients with esophageal cancer have poor prognosis with 5-year overall survival around 25%. Considering tumor-related death as main reason for high mortality rate in those patients, treatment-related cardio-pulmonary toxicities could also play a role in this regard. Online adaptive radiotherapy offers the possibility for daily re-planning and therefore helps radiation oncologists to better spare the organs at risk and reduce radiation-induced toxicity. Tha aim of ARTEC is to assess the pulmonary toxicity in patients with esophageal cancer treated with online adaptive radiotherapy.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with pulmonary toxicity
- timeFrame
- Up to 12 months after RCT
- description
- The primary endpoint of this prospective study is pulmonary toxicity after concurrent radio-chemotherapy for patients with esophageal cancer treated with ART. According to literature, around 10 - 25%- of EC patients experience radiation induced pulmonary complications (RIPC) after combined radio-chemotherapy. However, the high rates of toxicity (up to 25%) were seen in patients irradiated with old RT techniques, such as 3D-CRT (Conformal Radiotherapy). New data, using modern RT, show much less pulmonary toxicity (10%). RIPC includes mostly radiation pneumonitis, radiation pulmonary fibrosis and pleural effusion .
Secondary outcomes (2)
- measure
- Number of patients with pathological complete response
- timeFrame
- Directly after surgery up to two weeks
- description
- A pathological complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with RCHT. To find out if there is a pCR, a pathologist checks the tissue samples to see if there are still cancer cells left after the anticancer treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Histologically confirmed diagnosis of AC (Adenocarcinoma) or SCC (squamos cell carcinoma) of the thoracic esophagus or gastroesophageal junction (Siewert I-II) * Patients with cT2-4b cN0 cM0 or cTany cN+ cM0 or any patient with early stage EC ineligible for upfront surgery * Age \>= 18 years old * Karnofsky Performance Status (KPS) \>= 70 or ECOG (Eastern Cooperative Oncology Group) 0 - 1 * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with patients before registration in the trial Exclusion Criteria: * Cervical esophageal cancers (15-18 cm from the incisors) * Definitive clinical or radiologic evidence of metastatic disease * Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment * Prior thoracic radiotherapy that would result in overlap of radiation therapy fields * Induction chemotherapy for the current malignancy prior to RCHT is allowed if last dose is no more than 90 days and no less than 10 days prior to registration * Pregnant and/or breast-feeding females
References
Publications (0)
Data not yet available