Safety Study of Sequential and Synchronous ChemoRadiation and Cetuximab (Erbitux) in Patients with Stage III Non Small Cell Lung Cancer. SCRATCH Pilot Study - SCRATCH Pilot Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000329-52-GB

Enrollment

Registered

2005-04-18

Start date

2005-06-07

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Non Small Cell Lung Cancer MedDRA version: 9.1 Level: LLT Classification code 10066490 Term: Progression of non small cell lung cancer

Interventions

Trade Name: Erbitux 5 mg/ml solution for infusion Product Name: Cetuximab Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed non-small cell lung cancer, stages IIIa + IIIb - Tumour judged inoperable by thoracic surgeon or after review using British Thoracic Society guidlines. Male and females aged 18 years or over. Respiratory function tests: FEV1 >/=1.0L and transfer factor >or 50% predicted. Dose Colume Histogram targes for limitation of pneumonites achievable: V20=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with pleural effusion. Patients with a previous malignancy. Prior thoracic RT. Patients who are unfit for the chemotherapy regimens in this protocol, eg severe uncontrolled concurrent medical illness. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of the SCRATCH trial is to assess the safety of synchronous radical RT and cetuximab, both with and without synchronous chemotherapy, in the treatment of stage III Non Small Cell Lung Canger (NSCLC). ;Secondary Objective: To quantify the levels of toxicity with different intensities of treatment within the study.; Primary end point(s): Primary objective is to assess the safety of synchronous ceutuximab with sequential and synchronous chemoradiation (ChemoRT) in patients with stage III non-small cell lung cancer.	—

Measure

Time frame

Main Objective: The primary aim of the SCRATCH trial is to assess the safety of synchronous radical RT and cetuximab, both with and without synchronous chemotherapy, in the treatment of stage III Non Small Cell Lung Canger (NSCLC). ;Secondary Objective: To quantify the levels of toxicity with different intensities of treatment within the study.; Primary end point(s): Primary objective is to assess the safety of synchronous ceutuximab with sequential and synchronous chemoradiation (ChemoRT) in patients with stage III non-small cell lung cancer.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026