Online adaptive radiotherapy for esophageal cancer
Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC)
This study tests if a new way of giving radiation therapy can help reduce lung side effects for patients with esophageal cancer who are also getting surgery and chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bern) |
| Trial ID | NCT06361043 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of online adaptive radiotherapy in reducing pulmonary toxicity in patients with esophageal cancer. It focuses on patients undergoing multimodal treatment, including surgery and chemotherapy, who are at risk of significant treatment-related toxicities. By utilizing advanced radiation techniques, the study aims to optimize radiation delivery and minimize damage to surrounding organs. The research will assess the impact of daily re-planning of radiation therapy based on tumor and organ changes during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction, who are eligible for multimodal treatment.
Not a fit: Patients with cervical esophageal cancers, metastatic disease, or those with prior thoracic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce radiation-induced toxicity and improve patient outcomes in esophageal cancer treatment.
How similar studies have performed: Previous studies have shown promise in using adaptive radiotherapy techniques for various cancers, suggesting potential success for this novel approach in esophageal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern
- Inselspital, University of Berne, Deparftment of Radio-Oncology — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Hossein Hemmatazad, MD
- Email: Hossein.Hemmatazad@insel.ch
- Phone: +41 31 632 26 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.