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Randomized Phase II Trial Comparing Three Timepoints to Integrate Stereotactic Body Radiotherapy with Systemic Therapy in Patients with Metastatic Aerodigestive Adeno- or Squamous-Cell Carcinoma

Randomized Phase II Trial Comparing Three Timepoints to Integrate Stereotactic Body Radiotherapy with Systemic Therapy in Patients with Metastatic Aerodigestive Adeno- or Squamous-Cell Carcinoma - TIME-2-INTERACT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037621
Enrollment
150
Registered
2025-09-23
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic adenocarcinoma or squamous cell carcinoma of the aerodigestive tract

Interventions

Group 1: Upfront stereotactic body radiation therapy (SBRT) before the initiation of systemic therapy: Patients assigned to upfront SBRT receive SBRT to all active extracranial tumor lesions before in

Sponsors

Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • histologically confirmed adenocarcinoma or squamous cell carcinoma of the aerodigestive tract with metastatic disease detected on imaging. Biopsy of metastatic disease is preferred but not required. • one to ten extracranial active tumor lesions on recent imaging • all relevant tumor lesions can be treated with radiotherapy based on the judgment of the treating radiation oncologist • initiation or change of systemic therapy is clinically indicated but has not yet started • ECOG 0/1 • age =18 years • able and willing to provide informed consent

Exclusion criteria

Exclusion criteria: • serious medical comorbidities precluding ablative radiotherapy • substantial overlap of disease sites with a previously treated radiation volume that precludes meeting dose constraints in a composite plan • malignant meningitis • pregnant or lactating individuals • patient’s refusal to participate

Design outcomes

Primary

MeasureTime frame
The primary objective is to compare PFS (18 months) between all groups.

Secondary

MeasureTime frame
event-free survival, overall survival, new lesion-free survival

Countries

Germany

Contacts

Public ContactThomas Held

Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie

thomas.held@med.uni-heidelberg.de+49 6221-56-34058

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026