Know Cancer

or
forgot password

Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer


Inclusion Criteria:



- Patients must have FDG-avid and pathologically proven non-small cell lung cancer. If
pathology not definitive, the patient needs to have a clinically diagnosed non-small
cell lung cancer, which is also FDG-avid.

- Patients must be 18 years of age or older.

- Patients must have Karnofsky performance score > 60.

- Patients must have clinical AJCC Stage I-IIIB, with unresectable or inoperable
disease.

- Patients must have no evidence of a malignant pleural or pericardial effusion

- Patients must have hemoglobin > 10 gm/dl. Transfusions or medications may be used to
achieve this criterion.

- Patients must have reasonable organ and marrow functions as defined below if
chemotherapy is considered:

- WBC > 3,000/mm3.

- absolute neutrophil count ≥ 1,500/mm3.

- platelets > 100,000/mm3

- total bilirubin ≤ 3.0 mg/dl.

- AST (SGOT) and ALT (SGPT) < 4 X institutional upper limit of normal.

- creatinine ≤ 2.0 mg/dl.

- Patients must not have serious intercurrent diseases per the judgment of the treating
physician.

- Patient must be willing to use effective contraception if female with reproductive
capability.

- Patients must be informed of the investigational nature of this study and given
written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

- Patients with any component of small cell lung carcinoma are excluded from this
study.

- Prior radiotherapy to the thorax such that composite radiation would significantly
overdose critical structures, either per estimation of the treating radiation
oncologist or defined by failure to meet normal tissue tolerance constraints.

- Pregnant women are excluded from this study because radiation has the potential for
teratogenic or abortifacient effects.

- Prisoners are excluded for this study.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Using FGD-PET-CT During Radiation Therapy(RT)

Outcome Description:

During-RT, using PET-CT based adaptive radiation to deliver a higher total dose to the active tumor, will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.

Outcome Time Frame:

2-5 years

Safety Issue:

No

Principal Investigator

Feng-Ming Kong, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2007.123

NCT ID:

NCT01190527

Start Date:

August 2008

Completion Date:

August 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Michigan Cancer CenterAnn Arbor, Michigan  48109