Phase III Randomized Study of Standard versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients with Stage II-III or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status

Study ID
STU 052011-093

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Irma Smith
214-633-1756
irma.charles@utsouthwestern.edu

Principal Investigator
Robert Timmerman

Summary

This study includes randomization to two arms. arm a (experimental arm) will include iGRT, 60 Gy in 15 fractions (3 weeks). arm B will include conventional radiation, 60-66 Gy in 30-33 fractions (6 weeks).

The experimental arm dose for this trial is based on a dose escalation trial at university of Texas Southwestern evaluating the maximum tolerated dose of hypofractionated iGRT in this patient population (Phase i study iRB #072010-050). Doses were escalated from 3 Gy per fraction (total dose 45 Gy) to 4 Gy per fraction (total dose 60 Gy) and evaluation for treatment related toxicity was being performed. Critical structure dose constraints will be expressed as organ dose-volume limits, with limits formulated with the approval of the study investigators using known tolerance data, radiobiological conversion models, and norms used in current practice at academic centers [27].

Randomization Scheme:
Patients will be allocated to the treatment using a randomized permuted block within strata to balance for patient factors other than institution. The stratifying variables are Zubrod performance status (2 vs. [Greater Than] 2) and stage (ii vs. iii).

Participant Eligibility

1. All patients must be willing and capable to provide informed consent to participate in the protocol.

2. Patients must have appropriate staging studies identifying them as AJCC stage II or III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix III), or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology within 6 months of study entry.

3. Patients must have the potential for benefit from local therapy (at the discretion of the investigator).

4. The patient[Single Quote]s Zubrod performance status must be 2 or greater OR patients with Zubrod performance status 0-1 and weight loss >10% are considered eligible. In addition, patients determined to be medically unfit or refusing combined modality therapy are eligible.

5. Age >= 18.

6. Patients must have measurable or evaluable disease by RECIST 9.3 criteria.

7. Women of childbearing potential and male participants must agree to use an effective method of contraception.

8. Patients must sign study specific informed consent prior to study entry.

9. Patients must not have plans for concurrent chemoradiation therapy.

10. Patients must complete all required pretreatment evaluations (section 4.0)