Pelvic Cancer Registry for Online Adapted Radiotherapy

NCT06185062 | Recruiting

• 1 other identifier: 2023-02727
• Study Type: observational
• Target: 846
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios. Primary endpoint:

• 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART Secondary endpoints:
• Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes
• Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score

Conditions

Pelvic Tumor; Thoracic Tumor

Keywords

online Adaptive Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Rate of acute radiotherapy related toxicity

  10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART

  until 12 weeks post RT

Study Arms (2)

oART

Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART (online Adaptied Radiotherapy).

IGRT

Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with conventional IGRT (Image Guided Radiotherapy).

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

This study will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT.

You may qualify if:

• Patients with pelvic or thoracic tumors with an indication for radiotherapy
• Patient information and declaration of consent
• Patients age ≥ 18 years

You may not qualify if:

• Prior radiotherapy in affected site

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center, Departement of Radiation Oncology

Göttingen, Germany

RECRUITING

MeSH Terms

Conditions

Pelvic Neoplasms; Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Laura Anna Fischer

CONTACT

+49 551 3964501; laura-anna.fischer@med.uni-goettingen.de

Rami El Shafie

CONTACT

rami.elshafie@med.uni-goettingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Study Management on behalf of the Principal Investigator

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

DE (1)