Inselspital, University of Berne, Deparftment of Radio-Oncology
Bern, 3010, Switzerland
Location status: Recruiting
Location contact
Hossein Hammatazad, MD
CONTACT
Timo Nannen
CONTACT
NCT Number: NCT06361043
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bern, 3010, Switzerland
Location status: Recruiting
Hossein Hammatazad, MD
CONTACT
Timo Nannen
CONTACT
Esophageal cancer (EC) is currently the tenth most common cancer and sixth leading cause of cancer-related mortality worldwide. Multimodal treatment strategy consisting of surgery with pre-/perioperative Radio-/chemotherapy (RCHT) regimens the standard of care for non-metastatic locally advanced EC. However, the treatment of EC is challenging and the risk of tumor recurrence remains high. Furthermore, toxicities of such combined treatments can be substantial and there is room for optimization of RT to reduce the radiation dose to heart and lungs. While 3D-conformal radiotherapy is traditionally used for treatment of EC, modern irradiation techniques, such as intensity-modulated radiotherapy (IMRT) or volumetric intensity modulated arc therapy (VMAT), are increasingly implemented in the management of EC. The investigators know from literature that esophageal motion could be a challenge and therefore bigger margins are needed to achieve an acceptable tumor coverage. In addition to positioning and motion uncertainties, there could be a substantial inter-fractional tumor size reduction during RCHT. Tumor shrinkage can consequently lead to OARs shifting into the target volumes, which results in excess radiation dose to OARs with increased toxicity. Adaptive radiotherapy (ART) is a treatment technique to do a re-planning during the course of treatment to adjust the delivery of radiation dose based on geometrical changes of tumor and OARs. Considering the uncertainties in OAR and tumor displacement positioning, as well as tumor size reduction during RCHT, makes EC a perfect candidate for ART. This single-arm prospective study aims to assess pulmonary toxicity and dosimetrical analysis of ART for EC.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 12 months after RCT
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 .
Time frame: Directly after surgery up to two weeks
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.
Time frame: Directly after radiotherapy up to two weeks
Dosimetrical analysis between scheduled and adaptive plans.
We set the dosimetric goals for target volumes and OARs as follows:
"Mean Dose to the heart should be less than 18Gy "Mean dose to the liver should be less than 18Gy
All these values will be extracted from treatment planning system (TPS) for both adaptive and scheduled plans. Comparing these two data sets, we will demonstrate if patients profited from OART from dosimetrical point of view
Contact information is provided by the study sponsor or research team.
Hossein Hemmatazad, MD
CONTACT
Timo Nannen
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
Acronym: ARTEC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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