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Late Toxicity in the GETUG 06 Randomized Trial Comparing 70 Gy and 80 Gy for Localized Prostate Cancer

https://doi.org/10.1016/j.ijrobp.2007.07.1382Get rights and content

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Purpose/Objective(s)

Following a phase II feasibility trial of a 80 Gy-level dose in the treatment of prostate cancer, a randomized trial was conducted to compare outcomes after 70 or 80 Gy without hormonal therapy. The study was conducted on the behalf of the GETUG, the PHRC and the Ligue contre le Cancer.

Materials/Methods

From September 1999 to February 2002, 306 patients were randomized to receive 70 Gy (153 pts) or 80 Gy (153 pts) in 17 centres. Patients had intermediate prognosis tumour. When risk of lymph node involvement was >10%, lymphadenectomy was performed (159 pts) and patients were included if lymph nodes were not involved. In the case of a trans-urethral resection of the prostate (22 pts) radiotherapy was delayed of 2 months. No androgene deprivation was allowed before, during or after radiation

Results

In the 70 Gy arm, the mean dose to the PTV2 was 69,5 Gy (SD = 1,78) and the mean minimal dose was 65.5 Gy (SD = 3.31). In the 80 Gy arm, the mean dose in the PTV2 was 78,5 Gy (SD = 1), the mean minimal dose was 71,3 Gy (SD = 2,12) and the mean minimal dose to 85% of the PTV2 was 76.6 Gy (SD = 1.31). The mean follow-up was 57 months. At 70 and 80 Gy, grade 1,2, 3 rectal toxicities were 23, 12, 2% versus 25, 16, 6% mainly rectal bleeding 19 versus 28% and proctitis 10 versus 14%. Grade 1,2, 3

Conclusions

Tolerance of the conformal definitive radiotherapy was acceptable and comparable in both arms fotrectum toxicity with our constrainst. Bladder constraints should minimize secondary effects.

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Author Disclosure: V. Beckendorf, None; S. Guerif, None; E. Le prise, None; J.M. Cosset, None; O. Le floch, None; B. Chauvet, None; N. Salem, None; O. Chapet, None; S. Bourdin, None; P. Bey, None.

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