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Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using FDG-PET-CT Scan in Stage IB, II and III NSCLC (PET Boost)

This study is currently recruiting participants.
Verified January 2012 by The Netherlands Cancer Institute
Sponsor:
Collaborators:
Maastricht University Medical Center
GROW
Maastricht Radiation Oncology
Artforce
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01024829
First received: December 1, 2009
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. All patients will receive 24 radiations. Dose increasement will be enabled by a so called integrated boost.

Furthermore:

  • PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.
  • Dynamic Contrast-Enhanced CT imaging

Condition Intervention Phase
NSCLC
 Radiation: Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Escalation by Boosting Radiation Dose Within the Primary Tumor on the Basis of a Pre-treatment FDG-PET-CT Scan in Stage IB, II and III NSCLC: a Randomized Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • Local progression-free survival at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: May 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Whole tumor boost
Patients in this arm will receive radiotherapy (66Gy) in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole
 Radiation: Radiotherapy
Radiotherapy
Other Name: Radiotherapy
Boost 50% SUV area
Patients in this arm receive radiotherapy (66Gy) in 24 fractions of 2.75Gy with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET-CT scan)
 Radiation: Radiotherapy
Radiotherapy
Other Name: Radiotherapy

Detailed Description:

A randomized phase II study will be conducted in patients with inoperable stage IB, II or III non-small cell lung cancer (NSCLC). The patients will be randomized to receive the standard 66 Gy given in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole (Arm A) or with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET scan) (Arm B). Both treatment arms may be combined with chemotherapy (concurrent or sequential). Patients fulfilling the eligibility criteria will be registered in the study, and an initial radiotherapy treatment planning will be performed. When an integrated boost to the primary tumor as a whole up to 72 Gy is not possible because of dose constraints, the patient will receive 66 Gy or lower according to the normal tissue tolerance (see below). They will not be randomized, but will be followed in the trial. As such, it will be clear which proportion of patients can receive an integrated boost and what the outcome is when dose-escalation is not possible.

Stage IB-II patients receive radiotherapy alone, and stage III patients combined chemotherapy and radiation. The patients may have received induction chemotherapy up to two cycles before registration in this trial. The statistical calculations have been performed to deal with this patient heterogeneity.

The primary objective of this study is to determine the local progression-free survival (LPFS)at 1 year.

Secondary objectives will be

  • Toxicity as a function of radiotherapy dose and volume of the tissue irradiated.
  • Overall survival.
  • Quality of life

Furthermore:

  • PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and four hours post injection.
  • Dynamic Contrast-Enhanced CT imaging
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients > 18 years with any subtype of pathologically proven (biopsy or cytology), non-small cell lung cancer. The diagnosis may be established from biopsy or cytology obtained from the primary tumor and/ or from metastatic lymph nodes.
  2. Minimal diameter of the primary tumor 4 cm, this to allow for boosting of sub-volumes.
  3. UICC Stage T2-4, N0-3, M0 disease (TNM definition see appendix 2).
  4. Only stage IB-II patients who are nog candidates for surgery are study candidates.
  5. Measurable disease at registration.
  6. ECOG-performance status ≤ 2 (see appendix 6)
  7. Lung function: FEV1 and DLCO at least 40 % of the age-adjusted normal value
  8. Willing and able to give a written informed consent.
  9. Patients with locoregional recurrent lung tumor following surgery or a second primary cancer (at least 3 years after treatment) are eligible, unless a pneumonectomy was performed.
  10. SUVmax in the pre-treatment FDG-PET scan ≥ 5 for the primary tumor.

  11. Adequate organ function, including the following:

    • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL.
    • Hepatic: bilirubin ≤ 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) ≤ 3.0 x ULN (AP, AST, and ALT ≤ 5 x ULN is acceptable if liver has tumor involvement).
    • Renal: calculated creatinine clearance (CrCl) ≥ 45 ml/min based on the original weight based Cockcroft and Gault formula
  12. For women: Must be surgically sterile, postmenopausal, or compliant with a highly reliable contraceptive method (failure rate <1%) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be breast-feeding.
  13. For men: Must during chemotherapy take adequate contraceptive measures.

Exclusion Criteria:

  1. Prior radiotherapy to the thorax.
  2. Clinical superior vena cava syndrome, malignant pleural effusion or malignant pericardial effusion.
  3. Tumor growth in large blood vessels on spiral CT scan (encasement is eligible).
  4. T4 because of multiple nodules in the same or ipsilateral lobe(s).
  5. Post-obstructive atelectasis or infiltration that cannot be distinguished from tumor on a CT-PET scan.
  6. Patients with a diagnosis of other cancer within the last 3-years (except in situ carcinoma's and / or non-melanoma skin cancer).
  7. Patients taking non-steroidal anti-inflammatory drugs (NSAID) or acetylsalicylic acid may not receive pemetrexed.
  8. Pregnant women, lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024829

Contacts
Contact: Dirk De Ruysscher, MD, PhD +31 88 44 55 666 dirk.deruysscher@maastro.nl

Locations
Netherlands
MAASTRO clinic Recruiting
Maastricht, Limburg, Netherlands, 6229 ET
Contact: Dirk De Ruysscher, MD, PhD     +31 88 44 55 666     dirk.deruysscher@maastro.nl    
Principal Investigator: Dirk De Ruysscher, MD, PhD            
NKI/AvL Recruiting
Amsterdam, Netherlands
Principal Investigator: José Belderbos            
Sponsors and Collaborators
The Netherlands Cancer Institute
Maastricht University Medical Center
GROW
Maastricht Radiation Oncology
Artforce
Investigators
Principal Investigator: José Belderbos, MD, PhD NKI-AvL
  More Information

No publications provided

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01024829     History of Changes
Other Study ID Numbers: PET Boost
Study First Received: December 1, 2009
Last Updated: January 17, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
Non small cell lung cancer
Inoperable
HX4

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013