AROI-ESTRO GYN Teaching Course

A Phase II Randomized Trial Comparing Intensity Modulated Radiation Therapy

(IMRT) with Conventional Radiation Therapy in Stage IIB Carcinoma Cervix

(NCT00193804/TMH/158/2004): November 2004

Carcinoma Cervix Stage IIB (SQ / Adeno CA)

100 patients IMRT Pelvis (50 Gy/25#) + ICA – HDR (7 Gy x 5#) with Concomitant Chemo-radiation

100 patients Conventional External RT (40 Gy /20#) + ICA – HDR (7 Gy x 5#) with Concomitant Chemo-radiation

HYPOTHESIS:

• Reduction in Acute and Late RT toxicity’s by:15-25%

• Accrual Period: 5 years

• Power of detection: 80% (alpha error: 0.05)

Final Analyses: Ongoing