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NCT06361043Recruiting

Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC)

Source: ClinicalTrials.gov · Last updated 25 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
25 Mar 2024
Start date
20 Apr 2024
Primary completion date
28 Feb 2027
Lead sponsor
Insel Gruppe AG, University Hospital Bern
NCT number
NCT06361043

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 20 Apr 2024 to the primary completion date, 28 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior 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

Other illness

  • 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

Other

  • Pregnant and/or breast-feeding females

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inselspital, University of Berne, Deparftment of Radio-Oncology
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.