Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Hormones

Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.

Women with rectal cancer treated with surgery alone (no RT).

Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.

Preoperative radiotherapy

Anna Martling

Preoperative radiotherapy (RT) and pelvic surgery is recommended to many patients with rectal cancer. For women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where androgen levels and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

Women with rectal cancer stage I to III planned for abdominal surgery was included in the study. Women treated with preoperative RT were assigned to the exposed group and women treated with surgery alone were assigned to the unexposed group.

142 participants were enrolled at five outpatient rectal cancer centres in Sweden between 2008 and 2013. Patient data, fasting venous blood samples and questionnaires regarding sexual function and well-being were collected at a baseline visit before start of oncologic treatment, 1 year after surgery and 2 years after surgery (only questionnaires). Women treated with preoperative RT for rectal cancer had an additional venous blood sample taken the day before surgery.

Changes in serum levels of testosterone and sexual function during follow-up was assessed and compared between exposed and unexposed participants.

Sexual Function and Wellbeing in Females With Rectal Cancer

Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer

Fasting venous blood samples were collected at baseline visit (prior to oncological treatment) and 1 year follow-up. Participants treated with preoperative radiotherapy (RT) had an additional blood sample taken the day before surgery. Serum testosterone levels (T) were measured with liquid chromatography-mass spectrometry using the LC-MS/MS Quattro Premier Xevo TQ MS (Waters Corporation, Milford, MA, USA). The total coefficients of variation (CVtot) were 7% at 2.8 nmol/L and 6% at 15 nmol/L.

Sexual function was assessed using the Female Sexual Function Index (FSFI). The FSFI questionnaire is a 19-item multiple-choice, self-assessment tool validated for use in the general population as well as for patients with cancer. It covers six domains of sexual function in women; desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). Items scores between 0 or 1 to 5, with lower scores indicating worse function. A total FSFI score can be calculated when all items are completed. Minimal total score is 4 points and maximal score is 95 points, with lower scores indicating worse function. A total FSFI score of less than 26.55 points was used to define overall sexual dysfunction.

Swedish Cancer Society

Karolinska Institutet

Professor, Senior Consultant Surgeon

Preoperative RT

No Preoperative RT

Preoperative Radiotherapy

No Preoperative Radiotherapy

Total

Age, Continuous

Sex: Female, Male

Missing

ASA score is a classification system for physical status ranging from scores I to VI with higher scores indicating worse physical status. Definitions of scores: I = Normal healthy person, II = A patient with mild systemic disease, III = A patient with severe systemic disease.

ASA score

0-4 cm

5-10 cm

11-15 cm

Tumour distance from anal verge

Short course (5Gy x5)

Long course (2 Gy x25 or 1.8 x28)

No RT

Type of preoperative RT

Anterior resection

Abdominal excision

No abdominal surgery

Type of Surgery

Hysterectomy

Unilateral/bilateral oophorectomy

Partial vaginal resection

No resection

Includes resections before study inclusion and as part of rectal cancer surgery.

Resection of gynaecological organs

Pathological tumour stage is determined by examining tissue removed during surgery. Staging is based on the American Joint Committee on Cancer (AJCC) TNM system, with T being the extent of the tumour, N spread to nearby lymph nodes and M spread to distant sites. This is summarised into a score ranging from 0 to IV, with 0 being very early cancer and higher numbers indicating more advanced cancer.

Pathological tumour stage

Neoadjuvant chemotherapy

Adjuvant chemotherapy

Professor Anna Martling

The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).

Baseline

After RT/before surgery

1 year after surgery

17 of the included 142 participants were excluded due to history of oophorectomy, resulting in 125 participants analysed. Participants in the group "No preoperative radiotherapy" had no blood samples taken at the time point "After RT/before surgery".

Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.

The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using "no preoperative radiotherapy" as the reference group.

2 years after surgery

Of the 142 participants included in the study, 3 were excluded due to not answering FSFI questionnaires at any timepoint. Total FSFI scores were only calculated for available questionnaires without missing items.

Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.

Overall Study

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Raltitrexed

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

Treatment including preoperative chemoradiotherapy (preoperative radiation with concurrent chemotherapy) with Raltitrexed followed by surgery. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy or Volumetric-Modulated Arc Therapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on d1 and d22). Pelvic surgery is planned 6 weeks after completion of CRT based on the decision of MDT.

Preoperative radiation

Pelvic surgery

Jing Jin, MD

The aim of this multicenter phase II study is to evaluate the response rate, local control, disease-free survival and treatment-related toxicity of preoperative chemoradiation for intermediate or locally advanced rectal cancer in the fit elderly.

The concurrent chemoradiotherapy has become the standard treatment for patients with intermediate or locally advanced rectal cancer. However, the data from prospective trial for elderly patients is still lacking.

The aim of this multicenter phase II study is to evaluate the response rate, local control, disease-free survival and treatment-related toxicity of preoperative chemoradiation with Raltitrexed for intermediate or locally advanced rectal cancer in the fit elderly aged 70 years above.

And all the participants have to be evaluated by comprehensive geriatric assessment (CGA). Clinical stage was evaluated by chest and abdominal computed tomography, endorectal ultrasound, and/or pelvic magnetic resonance imaging.

5 weeks after the preCRT, the multi-disciplinary team decided the following treatment of patients based on imaging evaluation. Surgical resection would be done with a minimum interval of 6 weeks after the last radiation. Acute toxicity was evaluated during and within 2 weeks after CRT. Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

Sample size consideration.It has been calculated that 68 patients will need to be included, according to the following assumptions:

Recruitment period of 24 months. Minimum follow-up period of 24 months. We estimated that 51 patients were required to test the hypothesis that the 2-year DFS was equal to or greater than 78% with 80% power and to reject the hypothesis that the 2-year DFS rate was less than 63% at a significance level of 5% (one sided).Taking into account that a 5% percentage of losses, 20% of patients will refuse surgery, 68 patients are expected to be included in the study.

The interim analysis design. An interim safety evaluation will be carried out when 39 patients have finished their preoperative CRT. As the tolerance of elderly patients for nonhematological toxicities (such as diarrhoea) was often more poor than hematological toxicities, we estimated that 39 patients were required to test the hypothesis that the nonhematological G3 or higher acute toxicities rate was equal to or less than 21% ( safety result of patients aged 70 years or older from ACCOR12/PRODIGE 2 phase III trial) with 80% power and to reject the hypothesis that the rate was more than 36% at a significance level of 10% (one sided). If nonhematological G3 or higher acute toxicites is observed in12 or more patients, the H0 hypothesis will be rejected, and the protocal should be re-evaluated.

Biospecimen Retention. Blood, plasma, feces and tissue (optional). Feces were collected before any treatment. Peripheral blood samples of 10-20mL were collected from the patients for CTCs analysis, exploration analysis for frailty and tumor marker before and after preCRT, before and after surgery, and then on each follow up visit, according to our study protocal.

Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly

Multicenter, Phase II Study of Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly

To investigate the biomarker from blood or feces (such as circulating tumor cells, circulating tumor DNA) for treatment response and prognosis predicting. To investigate the CGA elements, and willingness evaluation to surgery for predicting the adherence, tolerence and prognosis of patients.

The probability of staying free from recurrence at 2 year after surgery or clinical complete response of tumor validated on imaging or pathological examination.

The probability of staying alive at 5 year after surgery or end of CRT (for those who did not receive surgery).

The probability of staying free from death caused by cancer at 5 year after surgery or end of CRT (for those who did not receive surgery).

The ratio of patients occured pathological complete response of tumor.

The quality of life assessment score by EORTC QLQ-C30 and EORTC QLQ-CR29.

Chinese Academy of Medical Sciences

Vice Chair of Radiation Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Retention

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

removal of urinary catheter postoperatively

removal of urinary catheter less than 24 hours after surgery

Early removal of urinary catheter postoperatively

removal of urinary catheter greater than 24 hours after surgery

Late removal of urinary catheter postoperatively

This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.

Optimal Management of Urinary Catheter in Gyn Onc

Optimal Management and Timing of Removal of Urinary Catheter Following Pelvic Surgery by the Gynecologic Oncology Surgeon

urinary retention rate will be measured as need for re-catheterization postoperatively

WellSpan Health

Site Director, Gynecology Oncology

Fluorouracil

Oxaliplatin

Neoadjuvant chemotherapy and chemoradiation

Chemoradiation

5-FU

Preoperative chemoradiation

Neoadjuvant oxaliplatin

Georg Høyer, DH

Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Effect of treatment, safety profile and quality of life scorings.

Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Oslo University Hospital

Senior consultant medical oncology

Symptoms and General Pathology

Infections

Musculoskeletal Diseases

Diseases and Abnormalities at or Before Birth

Hypertrophy

Spondylitis

Constriction, Pathologic

Spondylarthritis

Intervertebral Disc Displacement

Intervertebral Disc Degeneration

Spinal Stenosis

Spondylosis

Spinal Curvatures

Spinal Neoplasms

Osteoarthropathy, Primary Hypertrophic

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Joint Diseases

Pathological Conditions, Anatomical

Hernia

Bone Neoplasms

Genetic Diseases, Inborn

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from all patients who consent to participate in the study. EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient.

Two intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

Autonomic nervous system monitoring

Anna Lintelmann, MPH

Amy Schrecengost, BS

Nilanjana Banerji, MS, PhD

Stanley Skinner, MD

A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.

This is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery.

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. Throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. The success rates of 1) credible and safe EMG recording and 2) positive EMG responses to each stimulation method will be calculated.

Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded.

Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency in response to IOMN (intraoperative neuromonitoring) stimulations and recordings, will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sexual Function and Wellbeing in Females With Rectal Cancer	NCT01216189	Rectal Cancer	Preoperative ra...	18 Years -	Karolinska Institutet
Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly	NCT02992886	Rectal Neoplasm...	Preoperative ra... Raltitrexed Pelvic surgery	71 Years -	ChineseAMS
Optimal Management of Urinary Catheter in Gyn Onc	NCT05538273	Urinary Retenti...	Early removal o... Late removal of...	18 Years -	WellSpan Health
Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly	NCT02992886	Rectal Neoplasm...	Preoperative ra... Raltitrexed Pelvic surgery	71 Years -	ChineseAMS
Oxaliplatin and 5-FU Based Preoperative Chemoradiation	NCT00278694	Rectal Cancer	Oxaliplatin Chemoradiation 5-FU Preoperative ch... Pelvic surgery Neoadjuvant oxa...	18 Years -	Oslo University Hospital
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study	NCT02873182	Intervertebral ... Intervertebral ... Spinal Curvatur... Spinal Stenosis Spondylitis Spondylosis Osteoarthropath... Spinal Neoplasm...	Autonomic nervo...	18 Years - 70 Years	Allina Health System
Sexual Function and Wellbeing in Females With Rectal Cancer	NCT01216189	Rectal Cancer	Preoperative ra...	18 Years -	Karolinska Institutet

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