A prospective phase II study on dose escalation using PET based adaptive IMRT stage II-III non small lung cancer

A prospective phase II study on dose escalation using PET based adaptive IMRT stage II-III non small lung cancer - None

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003124-12-BE

Enrollment

Registered

2012-09-24

Start date

2012-10-30

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Stage II-III Non small lung cancer

Interventions

Product Name: 18F-FAZA Pharmaceutical Form: Solution for injection INN or Proposed INN: 1-(5-Deoxy-5-fluoro-a-D-arabinofuranosyl)-2-nitroimidazole CAS Number: 220793-03-3 Current Sponsor code: No Othe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histologically proven NSCLC • Non resectable stage III or medically inoperable stage II disease when a stereotactic treatment cannot be proposed • No contraindication for induction or concomitant chemotherapy • No prior thoracic radiation • Moderate-to-good lung function with : o FEV1/DLCO = 30% of the predicted value o FEV1 = 1L Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: •To assess the impact of individualized and escalated dose prescription based on FDG-PET on the tumor local control, the local progression-free survival and overall survival. •To secondarily assess early and late radio-induced toxicities ;Secondary Objective: To appraise the impact of potential tumor modifications during the treatment course for both volumetric and dosimetric changes by using repeated PET imaging with conventional tracer (FDG) and tracer of hypoxia (FAZA) ;Primary end point(s): a) Assess the metabolic response b) Acute toxicity and assessment of quality of life c) Follow up: history, physical examination, evaluation of quality of life and toxicities;Timepoint(s) of evaluation of this end point: Post-treatment FDG-PET will be obtained to assess the metabolic response after 4-8 weeks, 1 and 2 years. FDG-PET will allow to evaluate the local control, the regional control, the distant metastasis, and thus to estimate the progression-free survival rate. Acute toxicity and assessment of quality of life will be scored before the start of radiotherapy (baseline) and weekly during radiation treatment. After the last fraction, patients will be followed up regularly, after 2 weeks, 1 month, 3 months, 6 months, and afterwards at 6-month intervals until 2 years consisting of history, physical examination, evaluation of quality of life and toxicities.	—

Measure

Time frame

Main Objective: •To assess the impact of individualized and escalated dose prescription based on FDG-PET on the tumor local control, the local progression-free survival and overall survival. •To secondarily assess early and late radio-induced toxicities ;Secondary Objective: To appraise the impact of potential tumor modifications during the treatment course for both volumetric and dosimetric changes by using repeated PET imaging with conventional tracer (FDG) and tracer of hypoxia (FAZA) ;Primary end point(s): a) Assess the metabolic response b) Acute toxicity and assessment of quality of life c) Follow up: history, physical examination, evaluation of quality of life and toxicities;Timepoint(s) of evaluation of this end point: Post-treatment FDG-PET will be obtained to assess the metabolic response after 4-8 weeks, 1 and 2 years. FDG-PET will allow to evaluate the local control, the regional control, the distant metastasis, and thus to estimate the progression-free survival rate. Acute toxicity and assessment of quality of life will be scored before the start of radiotherapy (baseline) and weekly during radiation treatment. After the last fraction, patients will be followed up regularly, after 2 weeks, 1 month, 3 months, 6 months, and afterwards at 6-month intervals until 2 years consisting of history, physical examination, evaluation of quality of life and toxicities.

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Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Belgium

Outcome results

None listed

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