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

NCT06361043 | Recruiting

• 1 other identifier: 2023-01833
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Esophageal Cancer

Keywords

Esophageal cancer

Outcome Measures

Primary Outcomes (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 .

  Up to 12 months after RCT

Secondary Outcomes (2)

• Number of patients with pathological complete response

  Directly after surgery up to two weeks

• Dosimetrical analysis between scheduled and adaptive plans

  Directly after radiotherapy up to two weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, University of Berne, Deparftment of Radio-Oncology

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hossein Hemmatazad, MD

  Inselspital Bern, Department of Radio-Oncology

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 11, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CH (1)