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Esophageal CancerARTECNCT06361043

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

An observational study of Esophageal Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
How many people
30 participants
Where
1 siteSwitzerland
Study dates
20 Apr 2024to 28 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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 perioperative chemotherapy or preoperative radio-chemotherapy (RCHT) regimens the standard of care for locally advanced and potentially curable EC. For patients who decline surgery or patients in poor general condition and unfit for tumor resection, definitive RCHT alone could be considered as a reasonable treatment option.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hossein Hemmatazad, MD contact

+41 31 632 26 32

Hossein.Hemmatazad@insel.ch

Timo Nannen contact

+41 31 632 90 74

timo.nannen@insel.ch

Switzerland1 site, 1 recruiting

  • Inselspital, University of Berne, Deparftment of Radio-Oncology

    Bern, 3010

    Hossein Hammatazad, MD, +41 31 632 26 32, hossein.hemmatazad@insel.ch

    Timo Nannen, +41 31 632 90 74, timo.nannen@insel.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the detailed description

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.

Keywords
Esophageal cancer
Medical subject headings
Esophageal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with pulmonary toxicity

    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 .

    Measured: Up to 12 months after RCT

Secondary outcomes (2)

  1. Number of patients with pathological complete response

    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.

    Measured: Directly after surgery up to two weeks

  2. Dosimetrical analysis between scheduled and adaptive plans

    Dosimetrical analysis between scheduled and adaptive plans.

    We set the dosimetric goals for target volumes and OARs as follows:

    • CTV coverage: D95% >= 100.0%*
    • PTV coverage: D95% >= 100.0%
    • PTV Dminimum: D99% >= 99.0%
    • PTV Dmaximum: D1.0% <= 101.0%
    • Heart: Dmean < 18Gy°
    • Lung: V20Gy < 20% and mean lung dose (MLD) < 12Gy - Liver: Dmean < 18Gy"
    • Dose that covers 95% of target volume is equal or more than 100% of prescribed dose.

    "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

    Measured: Directly after radiotherapy up to two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start20 Apr 2024
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361043
Sponsor's protocol ID
2023-01833
Other IDs
2023
Acronym
ARTEC
Status last verified
Apr 2024
First submitted
25 Mar 2024
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hossein Hemmatazad, MD (+41 31 632 26 32, Hossein.Hemmatazad@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with pulmonary toxicity (time frame: Up to 12 months after RCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06361043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

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