6 cycle of oral vinorelbine or capecitabine combined with trastuzumab (21 days per cycle), followed by sequential single trastuzumab to 1 year

Breast Cancer

Vinorelbine

Capecitabine

Trastuzumab

Zhi-Ming Shao

Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

A Phase II Study to Assess the Effectiveness and Safety of Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

Zhimin Shao

professor

Fudan University

These patients will undergo robotic radical prostatectomy with bilateral nerve spare.The pathologist will remove the pre-painted surface of the gland (which had been in contact with the neurovascular bundles) using a sharp blade.The tissue sample will be snap frozen and embedded in OCT.Using a cryostat, 10 micron thick slices will be placed on slides.The entire length of the area of interest will be sampled in this way generating ≈10 frozen sections per side.The slides will be stained with H&E and will be examined by a consultant pathologist.As soon as examination is complete the pathologist will telephone the operating surgeon to give the result.Presence of cancer cells at the margin of resection constitutes a positive margin and the neurovascular bundle on that side will be resected

These patients will undergo robotic radical prostatectomy with a nerve sparing procedure based on surgical planning performed by a consultant radiologist. The mp-MRI will be reviewed by a consultant radiologist along with the details of the prostate biopsy and DRE a decision to perform unilateral, bilateral or non-nerve sparing will be established and recorded in the clinical record form (CRF) for each patient.

Prostate Cancer

When the prostate is removed from within the patient as it is disconnected from its attachments. The specimen will then be painted (right=blue, left =black) by the operating surgeon and delivered expediently to the pathologist who will perform frozen section analysis of the painted areas. The pathologist will remove the pre-painted surface of the gland (which had been in contact with the neurovascular bundles) using a sharp blade. The tissue sample will be snap frozen and embedded in OCT. If a positive margin is reported by the pathologist, the entire neurovascular bundle on the affected side will be removed and sent for formal pathological examination.

NeuroSAFE procedure

North Bristol NHS Trust

NHS Greater Glasgow & Clyde

University College London Hospital

Sheffield Teaching Hospitals NHS Foundation Trust

Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy.

A Single Blinded, Multi‐Centre, Randomised Controlled Trial to Evaluate NeuroSAFE Robotic Assisted Radical Prostatectomy (RALP) vs Standard Robotic Assisted Radical Prostatectomy (RALP) in Men With Prostate Cancer

Erectile function according to question 3 of the IIEF questionnaire validated patient reported outcome measure (PROM) questionnaire at 12 months.
3. Over the past 4 weeks when you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?
The question rated on a scale outlined below:
Did not attempt intercourse .……………...…….. 0 Almost never/never ……………………………... 1 A few times (much less than half the time) ….... 2 Sometimes (about half the time) …………..…... 3 Most times (much more than half the time) …... 4 Almost always/always ……………….………….. 5

Rates of Positive Surgical Margins as reported by pathologists (number of margins)

Rates of biochemical reoccurrence (BCR) as reported by PSA results (number of patients)

Rates of adjuvant therapies as reported by follow up visits (number of adjuvant therapies)

Cost of treatment for incontinence, impotence and adjuvant treatment. The cost for patients to travel to and from the hospital will also be recorded in a health economic diary. This inforamtion will be taken at each visit and analysed by a health economist after data lock.

Validated PROM questionnaires related to continence (ICIQ) - (measured on a scale 0 - 21, with 21 indicating severe incontinence and 0 being dry)

Validated PROM questionnaire related to quality of life. Scale is 1-5 with 1 having no limitations to everyday life and 5 being a severely diminished quality of llife

Validated PROM questionnaire related to quality of life. Scale is 1-5 with 1 indicating a good quality of life/excellent health and 5 being a significant reduction in quality of life/poor health.

All data will be anonymised at source. Only anonymised data will be shared.

University College, London

University College London Hospitals

NHS Greater Glasgow and Clyde

A single blinded, multi‐centre, randomised controlled trial. Parallel group, two-arm, with 1:1 allocation ratio between nerve sparing guided by NeuroSAFE and current UK practice (guided by MRI, biopsy and clinical examination).

Patients will be blinded as to whether the person has had NeuroSAFE procedure. The surgeon and pathologist cannot be blinded to this.

ophrys/zhubný nádor

Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy.

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