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Individualized Hypoxia-guided Radiotherapy Combined With Standard Cisplatin-etoposide in Stage I-III SCLC

18 Years
Not Enrolling
Small Cell Lung Cancer (SCLC)

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Trial Information

Individualized Hypoxia-guided Radiotherapy Combined With Standard Cisplatin-etoposide in Stage I-III SCLC

Hypoxic imaging with PET scans seems attractive for this purpose as hypoxia is associated
with resistance for radiotherapy and approximately 70 % of SCLC are severely hypoxic at

We hypothesize that it might be possible to use a selective boost in these patients to tumor
areas which are still hypoxic at the end of the standard chemo-radiotherapy to a dose of 45
Gy in 30 fractions in 3 weeks.

This way all SCLC (small cell lung cancer) patients can receive a safe, but higher dose of
radiotherapy to the whole tumor volume, while the most resistant areas receive the highest
possible dose.

This is a hypothesis generating trial designed to deliver at least the current standard
treatment to malignant tissue while defining patient selection criteria for future study.

Inclusion Criteria:

- Histologically or cytologically confirmed stage I-III small cell lung cancer. WHO
performance status 0-2

- Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and
hemoglobin at least 6.2 mmol/l.

- Adequate renal function: calculated creatinine clearance at least 40 ml/min

- Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for
the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution
(in case of liver metastases ≤ 5 x ULN for the institution)

- No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.

- Lung function: FEV1 at least 30 % and DLCO at least 30 % of the age predicted value

- No history of prior chest radiotherapy

- Life expectancy more than 6 months

- Willing and able to comply with the study prescriptions

- 18 years or older

- Not pregnant or breast feeding and willing to take adequate contraceptive measures
during the study

- Ability to give and having given written informed consent before patient registration

- No mixed pathology, e.g. non-small cell plus small cell cancer

- No recent (< 3 months) severe cardiac disease (NYHA class >1) (congestive heart
failure, infarction)

- No uncontrolled infectious disease

- No other active malignancy

- No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in
previous 4 weeks

- No treatment with investigational drugs in 4 weeks prior to or during this study

Exclusion Criteria:

- The opposite of the above

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cumulative local progression 18 months post-treatment as evaluated in a chest FDG-PET-CT scan

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dirk De Ruysscher, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

HX4 in small cell lung cancer



Start Date:

July 2013

Completion Date:

August 2014

Related Keywords:

  • Small Cell Lung Cancer (SCLC)
  • Toxicity
  • Progression
  • Survival
  • SCLC
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Anoxia