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Background Preoperative radiochemotherapy (RCT) is recommended in France prior to total mesorectal excision in patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N+) because it has been shown to improve local control. Preoperative RCT has also disadvantages including the absence of proven impact on metastatic recurrence and the risk of late side effects on bowel and genitourinary function. In patients with primarily resectable LARC, preoperative systemic chemotherapy without pelvic irradiation could be used as an alternative to RCT. Methods This study is a multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low resectable LARC (cT3N0 or cT1-T3N+ with circumferential resection margin [CRM] > 2 mm on pretreatment MRI) will be randomized to either modified FOLFIRINOX for 3 months or RCT (Cap50 intensified-modulated radiotherapy). All patients have restaging MRI after preoperative treatment. The primary endpoint is 3-year progression-free survival (PFS) from the time to randomization including progression during preoperative treatment. Secondary endpoints are treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response after preoperative treatment. The number of patients required is 574. Discussion The choice of modified FOLFIRINOX for preoperative chemotherapy is supported by recent and consistent data on safety and efficacy of this regimen on rectal cancer. The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors. However and first of all, the non-inferiority of preoperative chemotherapy compared to RCT on oncologic outcome has to be validated. If this study demonstrates the non-inferiority of chemotherapy compared to RCT, this can lead to a crucial change in clinical practice in a large subset of rectal cancer patients. Trial registration ClinicalTrials.gov NCT03875781 (March 15, 2019). Version 1.1.

Objective The aim of this study was to evaluate the effect of the interval between CRT and surgery on radiation proctitis, the pathologic response, and postoperative morbidity. Methods This was a cohort study from a phase III, randomized controlled trial (FOWARC study, NCT01211210). Data were retrieved from the leading center of the trial. Patients were divided into the short‐interval (≤7 weeks) group and the long‐interval (>7 weeks) group. The rate of radiation proctitis, pathologic complete regression (pCR) and morbidities were calculated for each group. Multivariate analysis was used to verify the impact of interval on radiation proctitis. Results Surgery was performed in 60 patients after an interval of ≤7 weeks and in 97 patients after an interval of >7 weeks. The two groups according to interval were comparable in terms of baseline demographic and clinicotherapeutic characteristics. Radiation proctitis was identified by imaging in 9 (15.0%) patients in short‐interval group and in 31 (32.0%) patients in long‐interval group (P = .018). Multivariate analysis confirmed the correlation between long interval and radiation proctitis (P = .018). The long interval was significantly associated with longer median operation time compared to the short interval (P = .022). The rates of pCR and postoperative complications were not different between two groups. Conclusions A longer interval after CRT may be associated with higher rate of radiation proctitis and longer operation time. Moreover it did not increase the rate of pCR. A longer interval after CRT may be associated with higher rate of radiation proctitis and more difficult surgical resection. Moreover it did not increase the rate of pCR.

PurposeTo assess the reproducibility of the dose–volume distribution of the initial simulation CT, generated using volumetric modulated arc therapy (VMAT) planning, during the radiotherapy of the prostatic bed based on weekly cone beam CTs (CBCT).MethodsTwenty-three patients, after radical prostatectomy were treated with adjuvant or salvage radiotherapy between July and December 2016 and considered for this evaluation. Weekly CBCT scans (n = 138) were imported into the treatment planning system, and the clinical tumor volume (CTV), the rectum and the bladder were contoured. The initially calculated dose distribution and the dose–volume histograms generated from weekly CBCTs were compared. The prostatic fossa dose coverage was assessed by the proportion of the CTV fully encompassed by the 95% and 98% isodose lines. Rectal and bladder volumes receiving 50, 60 and 65 Gy during the treatment were compared to the initial plan, with statistical significance determined using the one-sample t‑test.ResultsMarked variations in the total organ volume of the rectum and the bladder were observed. The correlation between rectum volume and V50 was not significant (p = 0.487), while the bladder volume and V50 demonstrated a significant correlation. There was no correlation between urinary bladder volume and CTV. The change in rectal volume correlated significantly with CTV. The dose coverage (D98% and D95%) to the prostatic bed could be achieved for all patients due to the ventral shift in the volume differences of the rectum.ConclusionWeekly CBCTs can be considered as adequate verification tools to assess the interfractional variability of the CTV and organs at risk. The proven volume changes in the urinary bladder and the rectum do not compromise the final delivered dose in the CTV.

Background This is a dosimetric comparative study intended to establish appropriate low-to-intermediate dose-constraints for the rectal wall (R wall ) in the context of a randomized phase-II trial on urethra-sparing stereotactic body radiotherapy (SBRT) for prostate cancer. The effect of plan optimization on low-to-intermediate R wall dose and the potential benefit of an endorectal balloon (ERB) are investigated. Methods Ten prostate cancer patients, simulated with and without an ERB, were planned to receive 36.25Gy (7.25Gyx5) to the planning treatment volume (PTV) and 32.5Gy to the urethral planning risk volume (uPRV). Reference plans with and without the ERB, optimized with respect to PTV and uPRV coverage objectives and the organs at risk dose constraints, were further optimized using a standardized stepwise approach to push down dose constraints to the R wall in the low to intermediate range in five sequential steps to obtain paired plans with and without ERB (Vm 1 to Vm 5 ). Homogeneity index for the PTV and the uPRV, and the Dice similarity coefficient (DSC) for the PTV were analyzed. Dosimetric parameters for R wall including the median dose and the dose received by 10 to 60% of the R wall , bladder wall (B wall ) and femoral heads (F Heads ) were compared. The monitor units (MU) per plan were recorded. Results Vm 4 reduced by half D 30% , D 40% , D 50%, and D med for R wall and decreased by a third D 60% while HI PTV , HI uPRV and DSC remained stable with and without ERB compared to Vm ref . HI PTV worsened at Vm 5 both with and without ERB. No statistical differences were observed between paired plans on R wall , B wall except a higher D 2% for F heads with and without an ERB. Conclusions Further optimization to the R wall in the context of urethra sparing prostate SBRT is feasible without compromising the dose homogeneity to the target. Independent of the use or not of an ERB, low-to-intermediate doses to the R wall can be significantly reduced using a four-step sequential optimization approach.

Radical radiotherapy is a standard form of management of localised prostate cancer. Conformal treatment planning spares adjacent normal tissues reducing treatment-related side effects and may permit safe dose escalation. We have tested the effects on tumour control and side effects of escalating radiotherapy dose and investigated the appropriate target volume margin. After an initial 3–6 month period of androgen suppression, 126 men were randomised and treated with radiotherapy using a 2 by 2 factorial trial design. The initial radiotherapy tumour target volume included the prostate and base of seminal vesicles (SV) or complete SV depending on SV involvement risk. Treatments were randomised to deliver a dose of 64 Gy with either a 1.0 or 1.5 cm margin around the tumour volume (1.0 and 1.5 cm margin groups) and also to treat either with or without a 10 Gy boost to the prostate alone with no additional margin (64 and 74 Gy groups). Tumour control was monitored by prostate-specific antigen (PSA) testing and clinical examination with additional tests as appropriate. Acute and late side effects of treatment were measured using the Radiation Treatment and Oncology Groups (RTOG) and LENT SOM systems. The results showed that freedom from PSA failure was higher in the 74 Gy group compared to the 64 Gy group, but this did not reach conventional levels of statistical significance with 5-year actuarial control rates of 71% (95% CI 58–81%) in the 74 Gy group vs 59% (95% CI 45–70%) in the 64 Gy group. There were 23 failures in the 74Gy group and 33 in the 64 Gy group (Hazard ratio 0.64, 95% CI 0.38–1.10, P =0.10). No difference in disease control was seen between the 1.0 and 1.5 cm margin groups (5-year actuarial control rates 67%, 95% CI 53–77% vs 63%, 95% CI 50–74%) with 28 events in each group (Hazard ratio 0.97, 95% CI 0.50–1.86, P =0.94). Acute side effects were generally mild and 18 weeks after treatment, only four and five of the 126 men had persistent ⩾Grade 1 bowel or bladder side effects, respectively. Statistically significant increases in acute bladder side effects were seen after treatment in the men receiving 74 Gy ( P =0.006), and increases in both acute bowel side effects during treatment ( P =0.05) and acute bladder sequelae ( P =0.002) were recorded for men in the 1.5 cm margin group. While statistically significant, these differences were of short duration and of doubtful clinical importance. Late bowel side effects (RTOG⩾2) were seen more commonly in the 74 Gy and 1.5 cm margin groups ( P =0.02 and P =0.05, respectively) in the first 2 years after randomisation. Similar results were found using the LENT SOM assessments. No significant differences in late bladder side effects were seen between the randomised groups using the RTOG scoring system. Using the LENT SOM instrument, a higher proportion of men treated in the 74 Gy group had Grade ⩾3 urinary frequency at 6 and 12 months. Compared to baseline scores, bladder symptoms improved after 6 months or more follow-up in all groups. Sexual function deteriorated after treatment with the number of men reporting some sexual dysfunction (Grade⩾1) increasing from 38% at baseline to 66% at 6 months and 1 year and 81% by year 5. However, no consistent differences were seen between the randomised groups. In conclusion, dose escalation from 64 to 74 Gy using conformal radiotherapy may improve long-term PSA control, but a treatment margin of 1.5 cm is unnecessary and is associated with increased acute bowel and bladder reactions and more late rectal side effects. Data from this randomised pilot study informed the Data Monitoring Committee of the Medical Research Council RT 01 Trial and the two studies will be combined in subsequent meta-analysis.

Background Prospective trials have demonstrated the advantage of dose-escalated radiotherapy for the biochemical and clinical control of intermediate risk prostate cancer. Dose escalation improves outcomes but increases risks of urinary and bowel toxicity. Recently the contribution of “spacers” positioned in the septum between the rectum and the prostate could improve the functional results of intensity modulated radiation therapy (IMRT). To date most of the evaluated devices were polyethylen glycol (PEG) and hyaluronic acid (HA). Men on the Spacer arm had decreased bowel toxicity and less decline in both urinary and bowel quality of life as compared to Control men in a randomized trial. Methods This is an interventional, multi-center study to evaluate the use of biodegradable inflatable balloon for patients with intermediate risk prostate cancer treated by IMRT (74 to 80 Gy, 2 Gy/fraction) with daily image guided radiotherapy. Discussion This multicenter prospective study will yield new data regarding dosimetric gain and implantation stages of Bioprotect balloon. Acute and late toxicities and quality of life will be registered too. Trial registration NCT02478112 , date of registration: 15/06/2015.

Background The STAR-TReC trial is an international multi-center, randomized, phase II study assessing the feasibility of short-course radiotherapy or long-course chemoradiotherapy as an alternative to total mesorectal excision surgery. A new target volume is used for both (chemo)radiotherapy arms which includes only the mesorectum. The treatment planning QA revealed substantial variation in dose to organs at risk (OAR) between centers. Therefore, the aim of this study was to determine the treatment plan variability in terms of dose to OAR and assess the effect of a national study group meeting on the quality and variability of treatment plans for mesorectum-only planning for rectal cancer. Methods Eight centers produced 25 × 2 Gy treatment plans for five cases. The OAR were the bowel cavity, bladder and femoral heads. A study group meeting for the participating centers was organized to discuss the planning results. At the meeting, the values of the treatment plan DVH parameters were distributed among centers so that results could be compared. Subsequently, the centers were invited to perform replanning if they considered this to be necessary. Results All treatment plans, both initial planning and replanning, fulfilled the target constraints. Dose to OAR varied considerably for the initial planning, especially for dose levels below 20 Gy, indicating that there was room for trade-offs between the defined OAR. Five centers performed replanning for all cases. One center did not perform replanning at all and two centers performed replanning on two and three cases, respectively. On average, replanning reduced the bowel cavity V20Gy by 12.6%, bowel cavity V10Gy by 22.0%, bladder V35Gy by 14.7% and bladder V10Gy by 10.8%. In 26/30 replanned cases the V10Gy of both the bowel cavity and bladder was lower, indicating an overall lower dose to these OAR instead of a different trade-off. In addition, the bowel cavity V10Gy and V20Gy showed more similarity between centers. Conclusions Dose to OAR varied considerably between centers, especially for dose levels below 20 Gy. The study group meeting and the distribution of the initial planning results among centers resulted in lower dose to the defined OAR and reduced variability between centers after replanning. Trial registration The STAR-TReC trial, ClinicalTrials.gov Identifier: NCT02945566. Registered 26 October 2016, https://clinicaltrials.gov/ct2/show/NCT02945566 ).

Background Recently, the use of hypo-fractionated treatment schemes for the prostate cancer has been encouraged due to the fact that α/β ratio for prostate cancer should be low. However a major concern on the use of hypofractionation is the late rectal toxicity, it is important to be able to predict the risk of toxicity for alternative treatment schemes, with the best accuracy. The main purpose of this study is to evaluate the response of rectum wall to changes in fractionation and to quantify the α/β ratio for late rectal toxicity Methods 162 patients with localized prostate cancer, treated with conformal radiotherapy, were enrolled in a phase II randomized trial. The patients were randomly assigned to 80 Gy in 40 fractions over 8 weeks (arm A) or 62 Gy in 20 fractions over 5 weeks (arm B). The median follow-up was 30 months. The late rectal toxicity was evaluated using the Radiation Therapy Oncology Group (RTOG) scale. It was assumed ≥ Grade 2 (G2) toxicity incidence as primary end point. Fit of toxicity incidence by the Lyman-Burman-Kutcher ( LKB ) model was performed. Results The crude incidence of late rectal toxicity ≥ G2 was 14% and 12% for the standard arm and the hypofractionated arm, respectively. The crude incidence of late rectal toxicity ≥ G2 was 14.0% and 12.3% for the arm A and B, respectively. For the arm A, volumes receiving ≥ 50 Gy (V50) and 70 Gy (V70) were 38.3 ± 7.5% and 23.4 ± 5.5%; for arm B, V38 and V54 were 40.9 ± 6.8% and 24.5 ± 4.4%. An α/β ratio for late rectal toxicity very close to 3 Gy was found. Conclusion The ≥ G2 late toxicities in both arms were comparable, indicating the feasibility of hypofractionated regimes in prostate cancer. An α/β ratio for late rectal toxicity very close to 3 Gy was found.

INTRODUCTION: Cervical cancer is the second most common cancer among Indian women. Radical radiotherapy with external beam radiation therapy (EBRT) and brachytherapy is the standard treatment for FIGO stage IB2 to IVA. An appropriate selection of brachytherapy applicator is needed according to the patient's anatomy. The two most commonly used applicators for intracavitary radiotherapy (ICR), Fletcher's and Henschke, have dosimetric differences which are not well studied with two-dimensional (2D)-based planning which is the most common method used for women with carcinoma cervix in India. The purpose of our study was to compare and evaluate the dosimetric differences between these two applicators, which would help in better selection of the applicator in cervical cancer patients. MATERIALS AND METHODS: This is a single-institute prospective study. Fifty patients randomly included in the study received EBRT and ICR by Ir192 HDR remote afterloading technique with computer-based 2D planning. Fletcher's and Henschke applicators were used alternately for first two fractions. RESULTS: The results of the study showed lower bladder and rectal doses with Fletcher's applicator and similar doses to point A for both applicators. However, point B doses are lower with Fletcher's applicator. CONCLUSION: Our results showed a favorable dosimetry with Fletcher's applicator in ICR of carcinoma cervix. The feasibility of placement is much better for Henschke but dosimetric advantages of Fletcher's encourage use of Fletcher's applicator for patients with favorable anatomy to reduce organs at risk doses but with the disadvantage of lower dose to point B.

Purpose Chronic hemorrhagic radiation proctopathy is not uncommon after radiotherapy for cervical carcinoma. The outcomes of several treatments have been variable. Many studies demonstrate that topical treatment with 4 % formalin is effective and safe. However, a nonrandomized control study showed a high response rate and good tolerance in chronic radiation proctopathy patients treated with 10 % formalin. The optimal concentration of formalin therefore remains unclear. Methods To compare the effectiveness and safety of 4 and 10 % formalin for the treatment of chronic hemorrhagic radiation proctopathy, a prospective trial was conducted at the Department of Gynecology of the Affiliated Hospital of Binzhou Medical College from January 2009 to December 2012. One hundred and twenty patients with chronic hemorrhagic radiation proctopathy following radiotherapy for cervical carcinoma were recruited and randomized to receive 4 or 10 % formalin. A standard protocol was followed for formalin application. Symptom and rectoscopy scores were evaluated before and at 12 weeks after treatment. Results In the 4 % formalin group, 49 (86.0 %) and 53 (91.4 %) patients showed an improvement in symptom score and rectoscopy score, respectively ( P  = 0.36). Symptom and rectoscopy scores decreased significantly after treatment in both the 4 % formalin group and the 10 % formalin group ( P  < 0.001). Symptom score was correlated with rectoscopy score ( P  < 0.001). More patients in the 10 % group suffered treatment-related complications than did those in the 4 % group ( P  = 0.03). Conclusions For the treatment of chronic hemorrhagic radiation proctopathy, 4 % should be the preferred formalin concentration.