59 research outputs found

    Preoperative chemoradiation with paclitaxel-carboplatin or with fluorouracil-oxaliplatin-folinic acid (FOLFOX) for resectable esophageal and junctional cancer: the PROTECT-1402, randomized phase 2 trial.

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    BACKGROUND: Often curative treatment for locally advanced resectable esophageal or gastro-esophageal junctional cancer consists of concurrent neoadjuvant radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy regimens in this setting is a combination of a fluoropyrimidin and of a platinum analogue. Due to the promising results of the recent CROSS trial, another regimen combining paclitaxel and carboplatin is also widely used by European and American centers. No clinical study has shown the superiority of one treatment over the other. The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments. Our aim is to evaluate, in operable esophageal and gastro-esophageal junctional cancer, the complete resection rate and severe postoperative morbidity rate associated with these two neoadjuvant chemotherapeutic regimens (carboplatin-paclitaxel or fluorouracil-oxaliplatin-folinic acid) when each is combined with the radiation regime utilized in the CROSS trial. METHODS/DESIGN: PROTECT is a prospective, randomized, multicenter, open arms, phase II trial. Eligible patients will have a histologically confirmed adenocarcinoma or squamous cell carcinoma and be treated with neoadjuvant radiochemotherapy followed by surgery for stage IIB or stage III resectable esophageal cancer. A total of 106 patients will be randomized to receive either 3 cycles of FOLFOX combined to concurrent radiotherapy (41.4 Grays) or carboplatin and paclitaxel with the same radiation regimen, using a 1:1 allocation ratio. DISCUSSION: This ongoing trial offers the unique opportunity to compare two standards of chemotherapy delivered with a common regimen of preoperative radiation, in the setting of operable locally advanced esophageal or gastro-esophageal junctional tumors. TRIAL REGISTRATION: NCT02359968 (ClinicalTrials.gov) (registration date: 9 FEB 2015), EudraCT: 2014-000649-62 (registration date: 10 FEB 2014)

    Adapted Prescription Dose for Monte Carlo Algorithm in Lung SBRT: Clinical Outcome on 205 Patients.

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    SBRT is the standard of care for inoperable patients with early-stage lung cancer without lymph node involvement. Excellent local control rates have been reported in a large number of series. However, prescription doses and calculation algorithms vary to a great extent between studies, even if most teams prescribe to the D95 of the PTV. Type A algorithms are known to produce dosimetric discrepancies in heterogeneous tissues such as lungs. This study was performed to present a Monte Carlo (MC) prescription dose for NSCLC adapted to lesion size and location and compare the clinical outcomes of two cohorts of patients treated with a standard prescription dose calculated by a type A algorithm or the proposed MC protocol.Patients were treated from January 2011 to April 2013 with a type B algorithm (MC) prescription with 54 Gy in three fractions for peripheral lesions with a diameter under 30 mm, 60 Gy in 3 fractions for lesions with a diameter over 30 mm, and 55 Gy in five fractions for central lesions. Clinical outcome was compared to a series of 121 patients treated with a type A algorithm (TA) with three fractions of 20 Gy for peripheral lesions and 60 Gy in five fractions for central lesions prescribed to the PTV D95 until January 2011. All treatment plans were recalculated with both algorithms for this study. Spearman's rank correlation coefficient was calculated for GTV and PTV. Local control, overall survival and toxicity were compared between the two groups.205 patients with 214 lesions were included in the study. Among these, 93 lesions were treated with MC and 121 were treated with TA. Overall survival rates were 86% and 94% at one and two years, respectively. Local control rates were 79% and 93% at one and two years respectively. There was no significant difference between the two groups for overall survival (p = 0.785) or local control (p = 0.934). Fifty-six patients (27%) developed grade I lung fibrosis without clinical consequences. GTV size was a prognostic factor for overall survival (HR = 1.026, IC95% [1.01-1.041], p<0.001) and total dose was a prognostic factor for local control (HR = 0.924, IC95% [0.870-0.982], p = 0.011). D50 of the GTV calculated with MC correlated poorly with the D95 of the PTV calculated with TA (r = 0.116) for lesions with a diameter of 20 mm or less. For lesions larger than 20 mm, spearman correlation was higher (r = 0.618), but still insufficient.No difference in local control or overall survival was found between patients treated with a type A or a type B algorithm in our cohort. A size and location adapted GTV-based prescription method could be used with a type B algorithm. External validation of these results is warranted

    Single-port or Classic Laparoscopy Compared With Laparotomy to Assess the Peritoneal Cancer Index in Primary Advanced Epithelial Ovarian Cancer

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    International audienceA thorough laparoscopic assessment of the abdominopelvic cavity is a crucial step in the workup of primary advanced epithelial ovarian cancer to decide whether up-front cytoreductive surgery or neoadjuvant chemotherapy is the best option for adequate management. The purpose of our study was to compare single-port laparoscopy (SPL), classic laparoscopy (CL), and laparotomy using the peritoneal cancer index (PCI). Patients treated for Fédération Internationale de Gynécologie et d'Obstétrique stage 3 or 4 epithelial ovarian cancer were included in our study when they underwent a PCI evaluation by laparoscopy followed by laparotomy for cytoreduction. According to the technique used for the "noninvasive" procedure (SPL vs CL), 2 groups were compared retrospectively. The individual records of all patients were reviewed and analyzed. From 2011 to 2014, 21 patients were assessed for PCI by SPL plus laparotomy versus 21 by CL plus laparotomy. The clinicopathological features were similar in both groups (not significant [NS]), except for performance status >0, which was more frequent in the SPL group (39% vs 6%, p = .04). Quotation of PCI was possible for all patients. Nonbrowsing areas marked 3 procedures in the SPL group and 2 procedures in the CL group (NS). The mean PCI score and the score of each region assessed by SPL and CL were comparable with the evaluation by laparotomy (NS). Completeness of cytoreduction was achieved in 78% of cases in both groups (NS). SPL and widely mini-invasive procedures seem to be effective tools compared with laparotomy to adequately assess the resectability of a peritoneal carcinomatosis usin

    Morbidity of Staging Inframesenteric Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer Compared With Infrarenal Lymphadenectomy

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    International audienceObjective: Extended-field chemoradiation is typically used for the management of patients with locally advanced cervical cancer. Given the low rate of skipped metastases above the inferior mesenteric artery, ilioinframesenteric dissection seems to be an acceptable pattern of paraaortic lymph node dissection (LND). Our objective is to compare the surgical morbidity of inframesenteric LND (IM-LND) with infrarenal LND (IR-LND).Methods: In our center, all of the patients with locally advanced cervical cancer and negative magnetic resonance imaging and positron emission tomography-computed tomography imaging at the paraaortic level were offered laparoscopic staging including a diagnostic laparoscopy followed, if negative, by an extraperitoneal paraaortic lymphadenectomy. From January 2011 to September 2015, we included patients who had paraaortic LND from both common iliac bifurcations and divided them into 2 groups according to dissection pattern: to the inferior mesenteric artery (IM-LND) level or to the left renal vein (IR-LND) level. The perioperative and postoperative data were retrospectively recorded.Results: A total of 119 women were included in our study: 56 in the IM-LND group and 63 in the IR-LND group. There was no difference in the patients' characteristics between groups. Regarding the surgical procedure, the operating time was shorter in the IM-LND group than the IR-LND group, 174 ± 50 minutes versus 209 ± 61 minutes (P = 0.001), respectively. There was no significant difference in intra- and postoperative complications, overall survival, or progression-free survival.Conclusions: In our series, exclusive IM-LND surgery is faster than IR-LND and results in similar morbidity and survival rates. These results confirm the feasibility and the applicability of IM-LND to simplify the surgical procedure without impacting survival. More patients should be included in the study to demonstrate the lower rate of morbidity

    A Multicenter Phase 2 Study of Ultrahypofractionated Stereotactic Boost After External Beam Radiotherapy in Intermediate-risk Prostate Carcinoma: A Very Long-term Analysis of the CKNO-PRO Trial

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    Background: Genitourinary (GU) or gastrointestinal (GI) complications and tumor relapse can occur in the long term after radiotherapy for prostate cancer. Objective: To assess the late tolerance and relapse-free survival (RFS) in patients undergoing hypofractionated stereotactic boost therapy after external beam radiotherapy (EBRT) for intermediate-risk prostate cancer. Design, setting, and participants: Seventy-six patients with intermediate-risk prostate carcinoma between August 2010 and April 2013 were included. The first course delivered a dose of 46 Gy by conventional fractionation; the second course was a boost of 18 Gy (3 × 6 Gy) within 10 d. Outcome measurements and statistical analysis: GU and GI toxicities were evaluated as the primary outcomes. The secondary outcomes were overall survival and RFS. The cumulative incidence of toxicity was calculated using a competing-risk approach. Overall survival and RFS were estimated using the Kaplan-Meier method. Results and limitations: The median follow-up period was 88 mo (range, 81–99 mo). Sixty (79%) patients were treated with the CyberKnife and 16 (21%) using a linear accelerator. The cumulative incidences of GU and GI grade ≥2 toxicities at 120 mo were 1.4% (95% confidence interval [CI]: 0.1–6.6%) and 11.0% (95% CI: 5.1–19.4%), respectively. The overall survival and RFS rates at 8 yr were 89.1% (95% CI: 77–95%) and 76.9% (95% CI: 63.1–86.1), respectively. Conclusions: A very long follow-up showed low GU and GI toxicities after a hypofractionated stereotactic boost after EBRT for intermediate-risk prostate cancer. Dose escalation of the boost delivered by hypofractionated radiation therapy appears safe for use in future trials. Patient summary: We found low toxicity and good survival rates after a short and high-precision boost after external beam radiotherapy for intermediate-risk prostate cancer, with a long-term follow-up of 88 mo. This long-term treatment is safe and should be considered in future trials
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