Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Carcinoma

Prostatic Neoplasms

Disease Progression

Neoplasms, Hormone-Dependent

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Docetaxel

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

37.5 mg orally once daily, continuously, for 6 cycles of 6 consecutive weeks.Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.

sunitinib

stephane OUDARD, professor

as second-line treatment in metastatic prostate cancer, the present study will investigate the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6 cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be treated until disease progression, pain progression, unacceptable toxicity or death due to any cause.

Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.

Follow-up for up to 1 year from the last dose of sunitinib.

* Antitumor efficacy of sunitinib will be assessed as follows:

  * PSA response rate and PSA progression according Working Group Criteria,
  * Variation of PSA doubling time (PSADT) before and after initiation of the treatment,
  * Objective response rate (ORR) according to RECIST criteria,
  * Clinical benefit,
  * Overall survival (OS).
* Pharmacokinetic endpoints will include sunitinib and its metabolite, SU012662, plasma levels and estimation of the population pharmacokinetic parameters as well as the inter-individual variability of these parameters, for a subgroup of 30 patients.
* The biological effects of sunitinib in patients with metastatic prostate carcinoma will be evaluated by measurements of the different biological markers that could be modulated by this antiangiogenic therapeutic, and could then predict and monitor disease progression and response to treatment:

  * Bone tumor markers: bone resorption markers (uCTX, uCTX, ICTP, CTX-MMP and TRACP-5b), bone formation markers (OC, PINP and BALP), osteoclastogenesis markers (OPG and RANKL) and parameters as calcium, phosphate, creatinine, albumin, PTH and 25(OH)D.
  * Angiogenesis markers: bFGF, SDF-1, VEGF-A, VEGFR1 and VEGFR2, CECs and CEPs, endothelial and platelet microparticles.

An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer

An Open Label Phase II Study of Oral Treatment With Sunitinib (SUTENT) in Patients Suffering From Hormone Refractory Prostate Cancer After Progression With Docetaxel Based Regimen

Assistance Publique - Hôpitaux de Paris

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neoplasm Metastasis

Respiratory Aspiration

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

Platelet Aggregation Inhibitors

Analgesics

Anesthetics

Propofol

Sevoflurane

Remifentanil

Anesthetics, General

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, Inhalation

Analgesics, Opioid

Narcotics

The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil.

The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil.

Propofol will be used for anesthesia maintenance in the total intravenous anesthesia group.

Sevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group.

Remifentanil will be used for analgesia in both groups.

Guizhi Du, MD, PhD

Jin Liu, MD, PhD

Yan Qiu, MD

The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. The purpose of the trial is to test whether inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing colorectal cancer resection through depression of lymphocytes-mediated immunity.

With the increasing number of patients diagnosed with colorectal cancer, the proportion of patients undergoing surgical resection with general anesthesia increased. However, the operation can lead tumor cells releasing into the blood or peritoneal implantation, and the impaired immune response can make patients susceptible to the development of tumor metastasis and recurrence which is the the main reason of death. It is well known that B lymphocytes and T lymphocytes are the main immune cells, and B lymphocytes by secreting antibodies are related to humoral immunity and T lymphocytes which play the most important role in antitumor are related to cell-mediated immunity. Surgery stress leads to metabolic and neuroendocrine changes causing significant depression of immunity. Although general anesthesia could reduce surgical stress, studies indicated general anesthetics including intravenous and inhalational agents both have variable effects on tumor cells growth by immuno-modulation and some cytokines. A number of studies have demonstrated deleterious effects on the function of lymphocytes associated with the administration of volatile inhalational anesthetic agents. It was suggested that the use of volatile inhalational agent may augment tumor cells growth by inhibiting the activity of lymphocytes, NK cells and dendritic cells which are important for recognizing, capturing and killing tumor cells, however, the alternative propofol has a converse (beneficial) effect by decreasing the plasma level of cytokines secreted by activated lymphocytes, macrophages and NK cells. The detailed mechanism of how volatile anesthetics affect the activity of antitumor cells remains unknown. Thus the investigators will conduct the clinical investigation to study the effect of volatile anesthetics on the immune response and metastasis in patients undergoing colorectal cancer resection, exploring molecular mechanism involved if inhalational anesthetics show an effect. The findings of this study would be valuable for anesthetic regimen guidance of colorectal cancer patients undergoing surgical resection in terms of long-term survival.

Blood of the enrolled patients will be sampled at different time-points for examination of lymphocytes.

The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved

Comparison of the Effects of Total Intravenous Anesthesia and Inhalation Anesthesia on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and the Mechanism Involved: a Single-center, Randomized, Prospective Study

Patients receive a reoperation for any reason during hospitalization

The duration of patients stay in hospital

Blood will be drawn preoperatively ( at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CD4+/CD8+, B lymphocytes, dendritic cells, natural killer cells

Patients who remain alive without known colonal or rectal tumor recurrence

Patients who remain alive with known colonal or rectal tumor recurrence

Patients who remain alive with known colonal or rectal tumor metastasis

Patients who have a surgery under general anesthesia

Total intravenous anesthesia, inhalational anesthesia or combined anesthesia

Patients have radiotherapy for any cancer

Patients have chemotherapy for any cancer

Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing circulating tumor cells

Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing IL, TNF-α, IFN-γ and GCSF

Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CEA, CA199, GP87 and TPA.

Guizhi Du

Associate Professor

Recurrence

Postoperative Complications

Neoplasm Recurrence, Local

Rectal Neoplasms

Disease Attributes

Neoplastic Processes

patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer

patients underwent conventional abdominoperineal resection for advanced very low rectal cancer

Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer

cylindrical abdominoperineal resection

Zhen Jun Wang, M.D.

Jia Gang Han, M.D.

Jian Hua Cai, M.D.

Hua Chong Ma, M.D.

Yan Fu Du, M.D.

Min Zhe Li, M.D.

Wei Tang Yuan, M.D.

Qun Qian, M.D.

Xian Dong Zeng, M.D.

Yong Dai, M.D.

Heng Ma, M.D.

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer

Abdominoperineal resection (APR) is still a common operation in patients with tumours less than 6 cm from the anal verge. The perineal phase of APR is a difficult part of the operation, often done with the patient in the supine position.The risk of inadvertent bowel perforation is high, the resulting specimen frequently has a waist at the lower border of the mesorectum, and the circumferential resection margin (CRM) is often close to the rectal muscle tube. The cylindrical APR may be performed via an extended posterior perineal approach, that aims to create a more cylindrical specimen without a waist. The potential benefit of this technique is a reduction in the risk of bowel perforation and tumour involvement of the CRM, and thus in the risk of local recurrence.

Perineal wounds in patients following APR are at considerable risk for infection, dehiscence and delayed healing when closed primarily. This can be further increased in patients who have received neoadjuvant chemoradiation therapy. The adoption of extended resection, such as the cylindrical APR, may cause additional risks. The use of acellular biomaterials, including human acellular dermal matrix (HADM) has drawn great interest for the complex abdominal wall reconstruction.

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer, and to determine the initial results of pelvic reconstruction using human acellular dermal matrix after cylindrical abdominoperineal resection.

circumferential resection margin; bowel perforation; cross sectional tissue area outside the internal sphincter; mean distance from the internal sphincter to the anterior, posterior and lateral circumferential resection margins

Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer

A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer

Shandong Provincial Hospital

Shandong Cancer Hospital and Institute

The First Affiliated Hospital of Zhengzhou University

Wuhan University

Shenyang Anorectal Hospital

Beijing Luhe Hospital

Beijing Chao Yang Hospital

Professor and Head of General Surgery

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Using the Modified BFM-90 protocol to treat Chinese children and adolescents with NHL

Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL

Modified BFM-90 protocol

Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol in Chinese children and adolescents with Non-Hodgkin's lymphoma.

Non-Hodgkin's Lymphoma (NHL) in children and adolescents include Burkitt's lymphoma (BL), diffuse large B cell lymphoma (DLBL), anaplastic large cell lymphoma (ALCL) and lymphoblastic lymphoma (LBL). These subtypes of NHL are an aggressive group of diseases. At present, in developed countries, 80 to 90% of children with NHL are cured by intensive, risk-adapted chemotherapy.The best protocols include BFM-90, LMB-89 and FAB/LMB/96. However, in developing countries, such as those with low and moderate incomes, the limited availability of resources is an obstacle for using these complicated and intensive protocols.As such, very simple protocols, such as the CHOP protocol, were often used to treat children and adolescents with NHL, thus resulting in poor survival rates. To improve the survival rate of Chinese children and adolescents with NHL, This study was designed to evaluate the efficacy and toxicity of this modified NHL-BFM -90 protocol in Chinese children and adolescents with NHL.

Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma

To assess and compare the characteristics of Chinese children and adolescents with NHL with that in western countries,such as sex, age, pathological subtypes,tumor involvement location and treatment outcome,and so on.

The event free survival (EFS) was defined as the time from the start of treatment to one of the following events: death from any cause, disease progression during treatment, relapse, or to the date of the last follow up if patient did not experience any event.

To assess the number of adverse events from the start of treatment to one of the following events: death from any cause, disease progression during treatment, relapse, severe infection, therapy related complication and second malignancy.

Sun Yat-sen University

Professor

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Cisplatin

Endothelial Growth Factors

Mitogens

Endostar protein

Endostatins

Tubulin Modulators

Antimitotic Agents

recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.

Treated by endostar combined with docetaxel and cisplatin

docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.

Treated by docetaxel and cisplatin

Shengqing Li, MD, PHD

Shengqing Li, MD. PHD.

Changgui Wu, MD, PHD

To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of non-small cell lung cancer, patients will be randomly assigned to the group one (endostar combined with docetaxel and cisplatin) and group two (docetaxel and cisplatin).

* The serum concentrations of Endostatin,VEGF and bFGF are determined.
* Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor cells (CPCs) will be measured by flow cytometer.
* Statistical analysis will be applied to study the relationship between the levels of Endostatin, VEGF, bFGF, CECs and CPCs and the clinical outcomes such as objective response rate(ORT), time to progression (TTP), mean survival time(MST), toxicity and quality of life (QOL).

To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of non-small cell lung cancer,patients will be randomly assigned to the experimental group(endostar combined with docetaxel and cisplatin) and the control group (docetaxel and cisplatin).

* the serum concentrations of Endostatin,VEGF and bFGF are determined.
* Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor cells (CPCs) will be measured by flow cytometer.
* the clinical parameters such as objective response rate (ORT),time to progression(TTP) and mean survival time(MST) will be collected according to the WHO criteria.
* the toxicity will be recorded according to the NCI-CTC v3.0.
* the Quality of life was self-assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire.
* Statistical analysis will be applied to study the relationship between the levels of Endostatin,VEGF,bFGF,CECs and CPCs and the clinical outcomes such as ORT, TTP, MST, toxicity and QOL.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer	NCT00748358	Prostatic Neopl... Neoplasms, Horm... Tumor Markers, ... Survival Rate Disease-Free Su...	sunitinib	18 Years -	Assistance Publique - Hôpitaux de Paris
An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer	NCT00748358	Prostatic Neopl... Neoplasms, Horm... Tumor Markers, ... Survival Rate Disease-Free Su...	sunitinib	18 Years -	Assistance Publique - Hôpitaux de Paris
The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved	NCT03193710	Colorectal Canc... Survival Rate General Anesthe... Lymphocyte Dest... Molecular Mecha...	Propofol Sevoflurane Remifentanil	18 Years - 65 Years	West China Hospital
Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer	NCT00949273	Rectal Cancer Treatment Postoperative C... Neoplasm Recurr... Survival Rate	cylindrical abd...	18 Years - 80 Years	Beijing Chao Yang Hospital
Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma	NCT01761500	Childhood Non-H...	Modified BFM-90...	6 Months - 20 Years	Sun Yat-sen University
Impact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)	NCT00657423	Lung Neoplasms	Treated by endo... Treated by doce...	18 Years - 75 Years	Xijing Hospital

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