Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II)

Background A resection with clear margins (R0 resection) is the most important prognostic factor in patients with locally recurrent rectal cancer (LRRC). However, this is achieved in only 60 per cent of patients. The aim of this study is to investigate whether the addition of induction chemotherapy to neoadjuvant chemo(re)irradiation improves the R0 resection rate in LRRC. Methods This multicentre, international, open-label, phase III, parallel-arms study will enrol 364 patients with resectable LRRC after previous partial or total mesorectal resection without synchronous distant metastases or recent chemo- and/or radiotherapy treatment. Patients will be randomized to receive either induction chemotherapy (three 3-week cycles of CAPOX (capecitabine, oxaliplatin), four 2-week cycles of FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) or FOLFORI (5-fluorouracil, leucovorin, irinotecan)) followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Tumours will be restaged using MRI and, in the experimental arm, a further cycle of CAPOX or two cycles of FOLFOX/FOLFIRI will be administered before chemoradiotherapy in case of stable or responsive disease. The radiotherapy dose will be 25 × 2.0 Gy or 28 × 1.8 Gy in radiotherapy-naive patients, and 15 × 2.0 Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825 mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-term oncological outcomes, radiological and pathological response, toxicity, postoperative complications, costs, and quality of life. Discussion This trial protocol describes the PelvEx II study. PelvEx II, designed as a multicentre, open-label, phase III, parallel-arms study, is the first randomized study to compare induction chemotherapy followed by neoadjuvant chemo(re)irradiation and surgery with neoadjuvant chemo(re)irradiation and surgery alone in patients with locally recurrent rectal cancer, with the aim of improving the number of R0 resections

Systematic review of health-related quality of life in patients undergoing pelvic exenteration

Background Pelvic exenteration is a radical operative treatment reserved for the management of a number of advanced primary and recurrent pelvic malignancies, including, rectal, gynaecological and urological. The advances in radiological staging, surgical techniques and greater use of chemotherapeutic agents haves translated clinically into improvements in the overall survival of this cohort of patients, irrespective of underlying disease pathology. Consequently, a greater proportion of the surviving population will present to healthcare professionals with a range of physical and psychological issues, therefore the profiling and understanding of the health-related quality of life (HrQoL) is integral to the long term management of this cohort of patients. The aim of this systematic review is to identify HrQoL themes from the current literature relevant to patients undergoing a pelvic exenteration. Methods Literature searches were performed in three databases: MEDLINE (1975–November 2015), EMBASE and CINAHL. Each study was evaluated with regards to its design and statistical methodology. Data quality was reviewed in accordance with the Newcastle-Ottowa score and Critical Appraisal Skills Programme Checklist (CAPS) for quantitative and qualitative data accordingly. A narrative synthesis of all identified HrQoL issues was undertaken using the principles of content analysis. Results A total of 24 studies were identified; 20 quantitative and 4 qualitative with 976 patients assessed in total. HrQoL was assessed as the main primary endpoint in 15 studies. The majority of studies were retrospective. Baseline data prior to the initiation of treatments were available in 6 studies alone. Nine themes were identified across the literature, which included body image, social impact, sexual function, treatment expectations, symptoms, communication, psychological impact, relationships and work and finance. Conclusions Pelvic exenteration has a wide ranging impact on patients HrQoL affecting a range of physical and psychological domains

An unexpected abdominal tumour in an elderly woman.

We report the case of a 73-year-old woman who presented with pain and an abdominal mass and was found to have an abdominal tumour of unexpected origin

Formation of a conceptual framework during the development of a patient reported outcome measure for Early Gastrointestinal Recovery: Phase I of the PRO-diGi study

Aim Patients admitted to hospital for abdominal surgery often experience gastrointestinal dysfunction. Many studies have reported outcomes following gastrointestinal dysfunction, yet there is no unified definition of recovery or a validated patient-reported outcome measure (PROM). The first stage of PROM development requires formation of a conceptual framework to identify key themes to patients. The aim of this study was to utilize semistructured interviews to identify core themes and concepts relevant to patients to facilitate development of a conceptual framework. Method Adult patients admitted to hospital for major gastrointestinal, urological or gynaecological surgery, in an emergency or elective setting, were eligible to participate. Patients treated nonoperatively for small bowel obstruction were also eligible. Interviews were conducted by telephone, audio-recorded, transcribed, coded and analysed using NVivo software by two researchers and reviewed by lay members of the steering group. Interviews continued until data saturation was reached. Ethical approval was gained prior to interviews (21/WA/0231). Results Twenty nine interviews were completed (17 men, median age 64 years) across three specialties (20 gastrointestinal, six gynaecological, three urological). Two overarching themes of ‘general recovery’ and ‘gastrointestinal symptoms’ were identified. General recovery included three themes: ‘life impact’, ‘mental impact’, including anxiety, and ‘physical impact’, including fatigue. Gastrointestinal symptoms included three themes: ‘abdominal symptoms’ such as pain, ‘diet and appetite’ and ‘expulsory function’, such as stool frequency. A total of 18 gastrointestinal symptoms were identified during patient recovery—many of which lasted several weeks following discharge. Conclusion This study reports a range of gastrointestinal and nongastrointestinal symptoms experienced by patients during early gastrointestinal recovery. Identified symptoms have been synthesized into a conceptual framework to enable development of a definitive PROM for early gastrointestinal recovery