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Aiden Lopez
Aiden Lopez

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Treatment of patients with non-metastatic, locally advanced rectal cancer (LARC) includes pre-operative chemoradiation, total mesorectal excision (TME) and post-operative adjuvant chemotherapy. This trimodality treatment provides local tumor control in most patients; but almost one-third ultimately die from distant metastasis. Most survivors experience significant impairment in quality of life (QoL), due primarily to removal of the rectum. A current challenge lies in identifying patients who could safely undergo rectal preservation without sacrificing survival benefit and QoL.

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The studies published thus far on the safety of NOM in LARC have compared survival between select groups of patients with a cCR after NOM, to patients with a pathologic complete response (pCR) after TME. The current study compares 3-year disease-free survival (DFS) in an entire population of patients with LARC, including those with cCR and those with pCR. We will compare the two arms of the study with respect to organ preservation at 3 years, treatment compliance, adverse events and surgical complications. We will measure QoL in both groups. We will analyze molecular indications that may lead to more individually tailored treatments in the future. This will be the first NOM trial utilizing a regression schema for response assessment in a prospective fashion.

This randomized phase II trial is designed to test the hypothesis that patients with LARC treated with TNT and TME, or NOM, will have improved 3-year DFS compared to patients treated with CRT, TME and ACT. This study investigates the efficacy of two neoadjuvant chemotherapy (NCT) schedules combined with CRT, in an effort to maximize the proportion of patients with LARC who may be cured without undergoing radical surgery. Patients with LARC who are considered candidates for a low anterior resection, a coloanal anastomosis (CAA) or abdominoperineal excision (APE) will be randomized to receive NCT, either a) before (Induction arm) or b) after (Consolidation arm) CRT. Patients will be restaged 8 (+/- 4) weeks after completing all neoadjuvant therapy. Those with incomplete tumor response will undergo TME. Patients with cCR will be observed, and only those showing signs of tumor relapse during follow-up will undergo TME. We have also put forth a novel regression schema to improve the uniformity of response assessment that will be tested and validated in a prospective fashion. To add value, we will measure QoL in patients treated with TNT and TME in comparison to patients treated with TNT alone. Additionally, we will compare induction chemotherapy (INCT) to consolidation chemotherapy (CNCT) with respect to organ preservation at 3 years, treatment compliance, adverse events and surgical complications.

The primary objective of the study is to evaluate 3-year recurrence-free survival (RFS) in patients managed with INCT or CNCT, CRT and selective NOM, compared with standard historical controls managed with CRT and TME followed by CT. Secondarily, this study seeks to: a) compare outcomes between patients in the two study arms with respect to rates of organ preservation, compliance with the neoadjuvant protocol, and adverse events; and b) measure patient-reported functional outcomes and QoL in patients with LARC treated with NCT, CRT and NOM, and compare these to patients treated with TME.

This study represents an attempt to investigate, in a multi-institutional setting, the feasibility of rectal preservation in a number of LARC patients who develop a cCR after a novel neoadjuvant therapy protocol. It has the potential to change the treatment paradigm for many patients with rectal cancer. The study design is innovative because it compares 3-year DFS in a group of LARC patients treated according to a protocol incorporating TNT and NOM, to a similar group of historical controls treated according to the standard CRT, TME and ACT protocol. The studies published thus far on the safety of NOM in LARC patients have compared the survival of a selected group of patients with a cCR and NOM, to a selected group of patients with a pCR after TME. While these reports provide an estimate of the safety of NOM, they do not provide accurate information on the impact of selective use of NOM on outcomes in the entire LARC population. Our study will be the first to determine the proportion of patients with LARC who will be candidates for NOM, and the impact of NOM on 3-year DFS in the entire LARC population.

In summary, this study will not only explore the feasibility of NOM in a selected group of patients with LARC who respond to neoadjuvant therapy. It will also provide a wealth of information about the response of LARC to chemotherapy and radiation. By delivering all adjuvant therapy up front, we will be able to discriminate (or separate) responders from non-responders, determining the real proportion of patients who will benefit from NOM, facilitating the clinical and radiological identification of responders, and facilitating molecular profiling. Finally, the study will help determine the gains in QoL associated with organ preservation.

JJS, OSC, MJG, and JGA wrote and edited the paper. JJS and JGA will contribute patients to the study and are active in management of the protocol. All authors have reviewed the research protocol, revising it critically for intellectual content. KA is the clinical research manager for the trial and verified the final criteria, edited the methods section, organized the website formation and development and continuously oversees the trial logistics. All authors have approved its current form. Each author has participated sufficiently in the work of reviewing and approving the protocol as written. It should be noted that JGA and JJS take primary responsibility for the writing and contents of the manuscript. In addition, GMN, LKT, MRW, JGG and PBP will contribute patients and have reviewed and approved the protocol. Other members of the Rectal Cancer Consortium include Drs. CT, DD, SO, DH, TC, TP, JC, MV, BP, JM, PC, CF, AC, JA, SH and JRTM. As mentioned, they each have reviewed and approved the protocol and will contribute patients to the study.

The treatment of organ-confined carcinoma of the prostate with permanent radioisotopes by the retropubic method has generated variable and controversial results. In this article, the technical flaws of the retropubic approach are discussed. Issues of radiobiological factors, dose inhomogeneity, and case selection are addressed relative to the reported results. Recent advances in radioisotope development, computer based dosimetry, and transrectal ultrasound and computed tomographic imaging have fostered techniques of closed transperineal implantation that produce a more homogeneous, reproducible, and larger volume implant with a higher peripheral dose rate than was possible in the past. With a median follow-up of 37 months (range 12 to 78 months), 93% of 291 early stage A-B patients treated with 125I or 103Pd alone showed a normal posttreatment prostate-specific antigen (PSA) (median value 0.4). In 160 more advanced stage A-C patients treated with external beam irradiation and implant boost, 85% showed a normal PSA (median value 0.3). The elimination of surgery with these techniques permits outpatient treatment resulting in high, patient acceptance. If longer follow-up substantiates the favorable early results, these methods may potentially offer the least morbid and least expensive method of treatment for early stage carcinoma of the prostate.

The main principle of all preservation methods used in the clinical situation today is that kidney metabolism can be reduced by hypothermia. Therefore, kidneys are normally stored at + 2 to + 4 C1. Lower temperatures are not used because of the fear of freezing and, therefore, of damaging the organ. In the experiments presented here we tried to improve the preservation results by a further reduction of metabolism at subzero temperatures. In doing so, freezing of the organ was prevented by the application of two different principles: in one part of the experiments the osmolality of the flush solution was increased by adding sucrose and in the other the penetrating cryoprotectant Me2SO2 was used. In detail, the following questions were investigated:

Organic farming is an agricultural method that aims to produce food using natural substances and processes. This means that organic farming tends to have a limited environmental impact as it encourages:

European Union regulations on organic farming are designed to provide a clear structure for the production of organic goods across the whole of the EU. This is to satisfy consumer demand for trustworthy organic products whilst providing a fair marketplace for producers, distributors and marketers.

In order for farmers to derive benefits from organic farming methods, consumers need to trust that the rules on organic production are being followed. Therefore, the EU maintains the following strict system of control and enforcement to guarantee that organics rules and regulations are being followed properly. As organic farming is part of a larger supply chain which encompasses food processing, distribution and retail sectors, these are also subject to checks.

The organic logo gives a coherent visual identity to EU produced organic products sold in the EU. This makes it easier for EU based consumers to identify organic products and helps farmers to market them across all EU countries.

The organic logo can only be used on products that have been certified as organic by an authorised control agency or body. This means that they have fulfilled strict conditions on how they are produced, transported and stored.

Organic farming is a fast growing area in EU agriculture, which is a direct result of increased consumer interest in organic products. In response to the challenges posed by this rapid expansion, and in order to provide an effective legal framework for the industry, the EU passed new legislation relating to the organic sector which applies from 1 January 2022. 041b061a72


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