Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Antirheumatic Agents

Anti-Inflammatory Agents

Pharmaceutical Solutions

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Trastuzumab

Carboplatin

Fluorouracil

Ethanol

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Hormones

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Epirubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Antineoplastic Agents, Immunological

Patients complete half of the whole cycles of neoadjuvant chemotherapy.

Patients complete whole cycles of neoadjuvant chemotherapy.

1. Evaluation of the tumor size by sonography is performed before neoadjuvant chemotherapy and prior to surgery.
2. Measurement of tumor size refers to WHO standards.

Ultrasound

Typically, the pretreatment tumor specimen will be a core needle biopsy. Because 15% to 28% of patients will have no residual tumor after NAT, it is important to have an adequate pretreatment sample in which an unequivocal diagnosis of invasive carcinoma is established and evaluation of hormone receptors and HER2/ neu status is completed before treatment.

All patients after neoadjuvant chemotherapy are performed BCS and modified radical mastectomy.

BCS, Modified Radical Mastectomy

1. Pathologic large tissue selected table has obtained Chinese patent.Its license ID is CN101261200.
2. Each piece of breast tissues by cutting with the table has 3mm thickness.

Pathologic Large Tissue Selected Table

Procedure:

1. Alcohol 70 % 1h
2. Alcohol 80 % 1h
3. Alcohol 85 % 1h
4. Alcohol 90 % 1h
5. Alcohol 95 % 1h
6. Alcohol Ⅰ 100 % 1h
7. Alcohol Ⅱ 100 % 1h
8. Xylene Ⅰ 2h
9. Xylene Ⅱ 2h
10. Xylene Ⅲ 2h
11. Paraffin 6h
12. Paraffin 6h

Leica TP1020

1. The table is made of brass .It is applying for a chinese patent.
2. The table can simultaneously embed 8 piece of breast tissues.

Pathologic Large Tissue Embedded Table

Each of paraffin section has 4 um thickness.

Leica SM2000 R

Procedure:

1. Xylene Ⅰ 60℃ 15-20 minutes
2. Xylene Ⅱ 60℃ 15-20 minutes
3. Alcohol 100% Ⅰ 3-5 minutes
4. Alcohol 100% Ⅱ 3-5 minutes
5. Alcohol 95% Ⅱ 3-5 minutes
6. Alcohol 90% Ⅱ 3-5 minutes
7. Wash in running tap water for 3 minutes
8. Hematoxylin 5-10 minutes
9. Wash in running tap water for 3 minutes
10. Differentiate in 1% acid alcohol for 30 seconds
11. Wash in running tap water for 1 minute
12. Bluing in 0.2% ammonia water for 30-60 seconds
13. Wash in running tap water for 3 minutes
14. Counterstain in eosin Y solution for 30-60 seconds
15. Wash in running tap water for 1 minute
16. Alcohol 90% Ⅱ 2-3 minutes
17. Alcohol 95% Ⅱ 2-3 minutes
18. Alcohol 100% Ⅱ 3-5 minutes
19. Alcohol 100% Ⅱ 3-5 minutes
20. Xylene Ⅲ 5-10 minutes
21. Xylene Ⅳ 5-10 minutes
22. Mounting with neutral resin

HE Stain

The residual tumor areas are microscopically outlined on each slice by pathologist.

CX22

1. Each slice that has been microscopically outlined is scanned by Epson V600.
2. Every image by scanning should be saved as JPG.

Epson V600

1. Evaluation of the tumor size by MRI was performed before neoadjuvant chemotherapy and prior to surgery.
2. Measurement of tumor size refers to WHO standards.
3. The images of patients which were scanned by MRI should be burned onto disc for 3d reconstruction.

A.Pathological images three-dimensional reconstruction:

1. Pathological images registration is based on skin and shear mark by Photoshop 13.0 software.
2. Residual tumor boundary on Pathological images after registration are outlined and taken three-dimensional reconstruction by 3D-doctor 4.0 software.
3. Observe the shrinkage modes in three-dimensional space.
4. According to WHO standard,the boundaries of all residual tumor images are displayed in one plane and the longest diameter and its longest perpendicular diameter of boundaries are measured in one-dimensional space.
5. According to RECIST standard,the longest diameter of boundaries of residual tumor images in three-dimensional space.

B.MRI images three-dimensional reconstruction:the procedure is similar to Pathological images three-dimensional reconstruction

Three-Dimensional Reconstruction

1. Evaluation of the tumor size by mammography is performed before neoadjuvant chemotherapy and prior to surgery.
2. Measurement of tumor size and calcification extent refers to WHO standards.
3. Calcification extent is not only measured in mammography image but also under microscope.

Mammography

1. TAC:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 3 cycles)
2. TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 2 cycles)
3. TA:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1(Cycled every 21 days for 2 cycles)
4. CAF:Cyclophosphamide 100 mg/㎡ po days 1-14 + Doxorubicin 30 mg/㎡ iv days 1,8 +5-fluorouracil 500 mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles)
5. CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles)

TAC,TC,TA,CAF,CEF

1. AC-P:Doxorubicin 60 mg/㎡ iv day 1 +Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 14 days for 4 cycles)→ Paclitaxel 175mg/㎡ by 3h iv infusion day 1(Cycled every 14 days for 4 cycles) or Paclitaxel 80mg/㎡ by 1h iv infusion weekly for 12 wks.
2. TEC:Docetaxel 75 mg/㎡ iv day 1 + Epirubicin 75 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 6 cycles)
3. AC:Doxorubicin 60 mg/㎡ in day 1 + Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 21 days for 4 cycles)
4. TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 4 cycles)
5. TCH:Docetaxel 75 mg/㎡ iv day 1 + Carboplatin AUC 6 iv day1(Cycled every 21 days for 6 cycles) + Trastuzumab 4 mg/kg iv wk 1 → Trastuzumab 2 mg/kg iv for 17 wks → Trastuzumab 6 mg/kg iv every 3 wks to complete 1 year.
6. CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 6 cycles)

AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF

Yong-sheng Wang, MD

Tao Yang, MD

The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC has been associated with significantly higher ipsilateral breast tumor recurrences.The accuracy of breast tumor excision in BCS can dramatically reduce IBTR.The main reseason of IBTR might be the uncertain shrinkage modes of the breast cancer after NAC.This clinical trial is firstly carried out to make clear the shrinkage modes of the primary tumor after 3 cycles and whole cycles of NAC,respectively,with whole-mount serial section(WMSS) and three-dimensional(3D) pathological reconstruction of the residual tumor.The second objective is to investigate the predictive value of 3D MRI reconstruction for the shrinkage modes of the primary tumor after NAC.

Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction

Phase III Trail of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction

The predictive value of 3D MRI reconstruction for the shrinkage modes of the primary tumor after whole cycles of NAC.

The tumor shrinkage modes of the primary tumor in patients with locally advanced breast cancer after 3 cycles and whole cycles of neoadjuvant chemotherapy(NAC).

The whole-mount serial section(WMSS) and three-dimensional(3D) pathological reconstruction of the residual tumors after NAC.

Shandong Cancer Hospital and Institute

Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Antiemetics

Gastrointestinal Agents

Vasoconstrictor Agents

Respiratory System Agents

Antihypertensive Agents

Analgesics

Anesthetics

Dexamethasone

Ropivacaine

Propofol

Epinephrine

Dexamethasone acetate

BB 1101

Racepinephrine

Epinephryl borate

Clonidine

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Local

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Sympatholytics

Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.

Study staff calls participant about 3 days after surgery.

Participants receive general anesthesia (GA) during surgery without a caudal nerve block.

Study staff calls participant about 3 days after surgery.

General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg.

Caudal Nerve Block (CNB)

Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.

Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.

Decadron 10 mg by bolus injection given by anesthesiologist in OR.

Decadron

Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.

General anesthesia given in the OR using Propofol titrated for induction.

Study staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes.

Phone Call

Bobby Bellard, MD

During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs.

The goal of this clinical research study is to learn how effective CNBs are in patients who are having penile prosthesis surgery compared to patients who only have general anesthesia by studying how long you stay in the hospital and the level of pain you have after surgery.

This is an investigational study. The general anesthesia and CNB used in this study are FDA approved and commercially available. It is considered investigational to compare the effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study doctor can explain how the study drugs are designed to work.

Up to 104 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups and CNB Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.

* If you are assigned to Group 1, you will receive a CNB and general anesthesia during surgery.
* If you are assigned to Group 2, you will only receive general anesthesia during surgery.

You will not know to which group you have been assigned. The CNB will be given to you while you are under general anesthesia. To receive a CNB, a special needle is inserted at the lower part of the back (near the tailbone). A type of local anesthesia is then injected into the sac surrounding the spinal cord that contains the nerves related to the penis.

All participants will also receive general anesthesia as part of their standard care. You will also receive a separate consent form for the surgery that explains the procedure and its risks, including the risks for general anesthesia.

After Surgery Data Collection:

During the 24 hours after surgery, the study staff will ask you to rate your pain on a scale of 0-10. You will be asked to rate your pain about every 30 minutes while you are in the hospital, but you may be asked to rate your pain more often if needed. It should take less than 5 minutes each time to rate your pain. Depending on how you rate your pain, additional pain drugs may be given to you as part of your standard care.

If you are discharged from the hospital on the same day as your surgery or if you are discharged before a member of the staff can ask you to rate your pain, the study staff will call you within 24 hours after you have been discharged from the hospital. This call should last about 5-10 minutes.

The amount of pain drugs given to you before, during, and after surgery will also be recorded.

About 3 days after your surgery, the study staff will call you to ask about your pain, the amount of pain drugs you have taken, and how satisfied you are with the type of anesthesia and pain control you have received. This call should last about 5-10 minutes.

Length of Study:

Your participation in this study will be over after the phone call about 3 days after your surgery has been completed.

Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery

Pain evaluated by the amount of intravenous and oral pain medicine administered in the first 24 hours post-operatively. Pain assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10, where 0 is no pain and 10 is the worst pain.

To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in decreased immediate postoperative pain in the first 24 hours after surgery compared with patients having only general anesthesia as determined by postop pain score. The mean, median and max pain will be assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10. The NRS will be used verbally. Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'

To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in a decreased length of hospital stay compared with patients having only general anesthesia.

Merck Sharp & Dohme LLC

M.D. Anderson Cancer Center

If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.

General Anesthesia and Caudal Nerve Block

Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction	NCT01917578	Breast Cancer	Ultrasound CNB BCS, Modified R... Pathologic Larg... Leica TP1020 Pathologic Larg... Leica SM2000 R HE Stain CX22 Epson V600 MRI Three-Dimension... Mammography TAC,TC,TA,CAF,C... AC-P,TEC,AC,TC,...	18 Years - 70 Years	Shandong Cancer Hospital and Institute
Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis	NCT02740127	Malignant Neopl...	Caudal Nerve Bl... Ropivacaine Epinephrine Decadron Clonidine Propofol Phone Call	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for cnb

Every month we try and update this database with for cnb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cnb

Every month we try and update this database with for cnb cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cnb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.