Hypoxia-guided Radiotherapy With Cisplatin-etoposide in Stage I-III : Small Cell Lung Cancer(SCLC)

NCT01210131 | Withdrawn

• 2 other identifiers: HX4 in small cell lung cancer2010-023033-30
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Since radiation dose escalation to a large volume of tumour inevitably will induce higher toxicity than is currently the case, efforts must be made to limit the volume of tissue irradiated. Moreover, the irradiation of larger tumour volumes leads to a lower achievable tumour dose when keeping the normal tissue doses constant. Central is thus the question whether it would be possible to limit the volume of tumour to be boosted by selectively escalating the radiation dose to specific disease sites which are theoretically more prone to relapse.

Conditions

Small Cell Lung Cancer (SCLC)

Keywords

Toxicity; Progression; Survival; SCLC

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (1)

• Overall survival

  2 years

Study Arms (1)

[18F]HX4

EXPERIMENTAL

Drug: [18F]HX4

Interventions

[18F]HX4 DRUG

Intravenous injection

[18F]HX4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• The opposite of the above

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Disease Progression

Interventions

3-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk De Ruysscher, MD, PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 28, 2010
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 27, 2013

Record last verified: 2013-01