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Purpose\udTo establish the toxicity profile of high-dose pelvic lymph node intensity-modulated radiation therapy (IMRT) and to assess whether it is safely deliverable at multiple centers.\udMethods and Materials\udIn this phase 2 noncomparative multicenter trial, 124 patients with locally advanced, high-risk prostate cancer were randomized between prostate-only IMRT (PO) (74 Gy/37 fractions) and prostate and pelvic lymph node IMRT (P&P; 74 Gy/37 fractions to prostate, 60 Gy/37 fractions to pelvis). The primary endpoint was acute lower gastrointestinal (GI) Radiation Therapy Oncology Group (RTOG) toxicity at week 18, aiming to exclude a grade 2 or greater (G2+) toxicity-free rate of 80% in the P&P group. Key secondary endpoints included patient-reported outcomes and late toxicity.\udResults\udOne hundred twenty-four participants were randomized (62 PO, 62 P&P) from May 2011 to March 2013. Median follow-up was 37.6 months (interquartile range [IQR], 35.4-38.9 months). Participants had a median age of 69 years (IQR, 64-74 years) and median diagnostic prostate-specific androgen level of 21.6 ng/mL (IQR, 11.8-35.1 ng/mL). At week 18, G2+ lower GI toxicity-free rates were 59 of 61 (96.7%; 90% confidence interval [CI], 90.0-99.4) for the PO group and 59 of 62 (95.2%; 90% CI, 88.0-98.7) for the P&P group. Patients in both groups reported similarly low Inflammatory Bowel Disease Questionnaire symptoms and Vaizey incontinence scores. The largest difference occurred at week 6 with 4 of 61 (7%) and 16 of 61 (26%) PO and P&P patients, respectively, experiencing G2+ toxicity. At 2 years, the cumulative proportion of RTOG G2+ GI toxicity was 16.9% (95% CI, 8.9%-30.9%) for the PO group and 24.0% (95% CI, 8.4%-57.9%) for the P&P group; in addition, RTOG G2+ bladder toxicity was 5.1% (95% CI, 1.7%-14.9%) for the PO group and 5.6% (95% CI, 1.8%-16.7%) for the P&P group.\udConclusions\udPIVOTAL demonstrated that high-dose pelvic lymph node IMRT can be delivered at multiple centers with a modest side effect profile. Although safety data from the present study are encouraging, the impact of P&P IMRT on disease control remains to be established.

Context: Radiotherapy is the cornerstone of treatment in nasopharyngeal cancer (NPC); the addition of chemotherapy has shown improved results. Aims: To compare the results of concurrent chemoradiation with that of radiotherapy alone in NPC. Materials and Methods: One hundred and ninety consecutive NPC patients, without distant metastasis, who reported to the institute from January 1992 to December 2001, received external-beam radiation to 66 Gy in 33 fractions. Seventy-five of these patients received concurrent chemotherapy with cisplatin and 5-fluorouracil (5-FU) for four cycles. We compared the results of treatment in these two groups. Results: The 5-year disease-free survival rates were 40% and 60%, respectively, for patients who had radiotherapy alone and those who had chemoradiation (P = 0.002), while the median survival was 45 months and 60 months, respectively (P = 0.0028). Conclusion: A significant improvement in local control and survival was observed by the addition of concurrent chemotherapy with cisplatin and 5-FU to radical radiation in this nonrandomized study on patients with NPC.

Objectives: To use an electroglottography (EGG)-based videostroboscopy tool to assess the anatomical and morphologic characteristics of the pharyngoesophageal (PE) segment in tracheoesophageal (TO) speakers. Study d0 esign: Cross-sectional cohort study. Subjects: Fifty-two post-laryngectomy patients with no recurrence and using prosthetic (Blom-Singer) speech. Intervention: An electroglottography (EGG)-based videostroboscopy tool EGG-based rigid videostroboscopy as well as perceptual evaluation. Outcome m0 easures: Stroboscopic protocol included nine subjective/visual parameters to evaluate the neoglottis and study correlation of the G (GRBAS scale) and the overall voice quality (OVQ) with the treatment variables. Results: Of the 52 laryngectomees, videostroboscopic recordings were possible in 46 patients (36 males and 10 females) with a mean age of 63.4 ±10.5 (SD) an electroglottography (EGG)-based videostroboscopy tool years. All used the Blom-Singer valve and the median time since Total Laryngectomy was 2 years. The neoglottis was assessable in 26 patients. We were able to strobe only 9 patients. There was excellent correlation between G and OVQ (Spearman rho > 0.9). Statistically significant correlation was found between G1 and saliva (P = 0.03) and between good OVQ and saliva (P = 0.02); similarly, there was significant correlation between G1 and LVV (P = 0.05) and between good OVQ and LVV (P = 0.03). Conclusions: This study is the first to examine the use of an EGG-based stroboscopy instrument to evaluate TO speech. Our observations suggest that from the standpoint of functional voice, saliva and the LVV had statistically significant effect in determining voice quality.