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Randomized Studies
- MD Anderson
- 2006 PMID 16504763 -- "Cluster model analysis of late rectal bleeding after IMRT of prostate cancer: a case-control study." (Tucker SL, Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):1255-64.)
- Paired case-control study, 9 patients with Grade 2+ late rectal toxicity compared with similar DVH patients without toxicity.
- Outcome: Patients with rectal toxicity had significantly larger mean maximum damaged cluster size. Highest prediction of difference at doses ~30 Gy
- Conclusion: Cluster model incorporates spatial information beyond DVH
- 2004 PMID 15590191 -- "Comparison of rectal dose-wall histogram versus dose-volume histogram for modeling the incidence of late rectal bleeding after radiotherapy." (Tucker SL, Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1589-601.)
- Planning comparison. Dose-volume histograms (DVH) vs dose-wall histograms (DWH) in 128 patients treated with 3D-CRT. Fit to 4 models (Lyman, mean-dose, parallel-architecture, cutoff-dose). Minimum 2 year F/U
- Slightly better performance for DWH model. Intermediate dose cut-off predicted as V32 >80%
- Conclusion: NTCP models fit slightly better with DWH as opposed to DVH
- 2004 (1992-1999) PMID 15050331 -- "Characterization of rectal normal tissue complication probability after high-dose external beam radiotherapy for prostate cancer." (Cheung R, Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1513-9.)
- Retrospective. 128 patients treated with 3D-CRT to 78 Gy. Endpoint Grade 2+ rectal bleeding. Minimal F/U 2 years
- Toxicity: Grade 2+ bleeding 23%
- Lyman model: TD50 = 53.6 Gy, n = 3.91, m = 0.156. Different with/without hemorrhoids
- Conclusion: Possibly large volume effect; LKB model should be used with caution
- 2002 (1993-1998) PMID 12128107 -- "Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial." (Pollack A, Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105.). Median F/U 5 years
- Dosimetric analysis of randomized trial. 301 T1-T3 patients, stratified by PSA <10 (65%), 10-20 (35%), >20 (few). Arm 1) 70 Gy vs. Arm 2) 78 Gy. Technique 4F 46/23, Arm 1) 4F RF 24/12, Arm 2) 3D-CRT 6 fields 32/16. CTV = prostate/SV, margin 1.5 cm anterior/inferior, 1.0 cm posterior/superior. No hormones
- Toxicity: Grade 2+ rectal toxicity 12% vs. 26% (p=0.001); Grade 2+ bladder toxicity NS. Less GI toxicity, if V70 <25% (16% G2) vs if V70 >25% (46% G2)
- Conclusion: Highly significant FFF improvement for intermediate-to-high risk patients, no benefit if PSA <10. Increased rectal toxicity
- 2006 PMID 16504763 -- "Cluster model analysis of late rectal bleeding after IMRT of prostate cancer: a case-control study." (Tucker SL, Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):1255-64.)
- RTOG 69
- 1000 pts. Randomized: 1) Foo or 2) No Foo.
- Results: Pts treated with foo had improved OS, 81% vs 50%.
- Conclusion: Foo is superior to no foo.
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