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Hypoxia-guided Radiotherapy With Cisplatin-etoposide in Stage I-III : Small Cell Lung Cancer(SCLC) (HX4 in SCLC)

Primary Purpose

Small Cell Lung Cancer (SCLC)

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

[18F]HX4

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer (SCLC) focused on measuring Toxicity, Progression, Survival, SCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]HX4

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival

Overall survival at two years

Full Information

NCT ID

NCT01210131

First Posted

September 21, 2010

Last Updated

August 26, 2013

Sponsor

Maastricht Radiation Oncology

Collaborators

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01210131

Brief Title

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

Acronym

HX4 in SCLC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Withdrawn

Study Start Date

July 2013 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht Radiation Oncology

Collaborators

Maastricht University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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 diagnosis[2]. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer (SCLC)

Keywords

Toxicity, Progression, Survival, SCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

[18F]HX4

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

[18F]HX4

Intervention Description

Intravenous injection

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival at two years

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dirk De Ruysscher, MD, PhD

Organizational Affiliation

Maastro Clinic, The Netherlands

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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