NCT06189898

Brief Summary

This trial on biomarker validation investigates the use of innovative re-staging FDG-PET parameters to detect highly chemoradiation (CRT) sensitive squamous cell carcinomas of the esophagus (SCEC) at the end of preoperative or definitive CRT.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
33mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Dec 2023Jan 2029

Study Start

First participant enrolled

December 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

5.1 years

First QC Date

December 19, 2023

Last Update Submit

December 19, 2023

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    progression free survival is defined as any tumor recurrence (local, regional and or distant) or death

    continiously with two year follow up

Secondary Outcomes (2)

  • Overall survival

    continiously with two year follow up

  • loco-regional recurrence free survival

    continiously with two year follow up

Interventions

Re Staging FDG-PETDIAGNOSTIC_TEST

Additional interim FDG-PET during week four of preoperative or definitive chemoradiation for esophageal carcinomas. Evaluation of standardized uptake ratio (SUR) and increased uptake of non tumor affected esophagus (Delta NTO).

Also known as: [18F]Fluorodeoxyglucose positron emission tomograhpy at week four radiochemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

For the primary endpoint only patients with squamous cell histology will be evaluated. Patients with adenocarcinomas will be used as exploratory cohort.

You may qualify if:

  • patients with squamous cell, undifferentiated or adenocarcinoma of the esophagus, UICC stage II-IVA (maximum T4a)
  • ECOG performace status 0-2
  • Complete clinical staging, including, esophagogastroscopy, EUS, CT neck/thorax/abdomen and adequate pulmonary function.
  • Adequate hematological, renal, hepatic and pulmonary functions defined as:
  • granulocytes ≥ 1.5 x 109/l platelets ≥ 100 x 109/l total bilirubin ≤ 1.5 x upper normal limit creatinine ≤ 120 μmol/L FEV1 ≥ 1.5 L
  • Written, voluntary informed consent
  • Willingness to perform effective contraceptive practices during treatment for patients with childbearing potential

You may not qualify if:

  • Evidence of distant metastases (cM1)
  • Prior high-dose radiotherapy to the thorax or abdomen
  • Primary tumor cT4b

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Related Publications (1)

  • Zschaeck S, Li Y, Butof R, Lili C, Hua W, Troost ECG, Beck M, Amthauer H, Kaul D, Kotzerke J, Baur ADJ, Ghadjar P, Baumann M, Krause M, Hofheinz F. Combined tumor plus nontumor interim FDG-PET parameters are prognostic for response to chemoradiation in squamous cell esophageal cancer. Int J Cancer. 2020 Sep 1;147(5):1427-1436. doi: 10.1002/ijc.32897. Epub 2020 Feb 19.

    PMID: 32010957BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tumor biopsies and primary cell culture, blood

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Sebastian Zschaeck, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Zschaeck, MD

CONTACT

++4930450650764sebastian.zschaeck@charite.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

December 15, 2023

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

January 5, 2024

Record last verified: 2023-12

Locations

DE(1)