Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

trastuzumab was administered concurrently with any anthracycline-containing adjuvant regimen

trastuzumab was administered sequentially to any anthracycline-containing adjuvant regimen

Trastuzumab will be administered concurrently with any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.

concurrent

Trastuzumab will be administered sequentially to any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.

sequential

Sun Qiang, Master

Most of the published data support the preferential use of an anthracycline-containing adjuvant regimen for individuals with HER2-positive tumors. Concurrent anthracyclines and trastuzumab, however, are contraindicated due to the observation of unacceptably high rates of cardiotoxicity in a large randomized trial in the metastatic setting. However, in neoadjuvant setting, trastuzumab concurrently with an anthracycline-containing chemotherapy regimen had shown high pathological complete response (pCR) and very low cardiotoxicity. All large adjuvant trials have evaluated only the sequential strategy of administering anthracyclines and trastuzumab. The safety and efficacy of trastuzumab concurrently with an anthracycline-containing chemotherapy regimen has never been evaluated in adjuvant setting. Given the similar patients characteristics, the investigators hypothesize that trastuzumab concurrently with an anthracycline-containing chemotherapy regimen would not increase cardiotoxicity but efficacy.

Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer

Safety and Efficacy Evaluation of Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer

the heart failure rate will be compared at 2 years, and left ventricular ejection fraction (LVEF) changes will be monitored during 3, 6, 9, 12, 24 months after firs dose of drug administration

local recurrence, regional recurrence, contralateral breast recurrence, distant metastasis, death

Peking Union Medical College Hospital

Symptoms and General Pathology

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Capecitabine

Antimetabolites

Xeloda

External Beam Radiotherapy

Zvi Bernstein, MD

Kuten Abraham, Prof.

Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief.

Primary Objective:

* To determine the frequency of pain relief for the proposed regimen.

Secondary Objective(s):

* To determine the duration of pain relief and narcotic relief for the proposed regimen.
* To determine the frequency of narcotic relief for the proposed regimen.
* To determine the toxicity of concurrent UFT and radiotherapy in patients with bone metastases.

Concurrent Xeloda and Radiotherapy for Bone Metastases

Rambam Health Care Campus

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Inductive chemotherapy :paclitaxel 175mg/m2 d1+ cisplatin 80mg/m2d1, every 21 days for two cycles concurrent chemotherapy:cisplatin 80mg/m2 on week 1, 4, 7 radiotherapy: IMRT

concurrent chemotherapy: cisplatin 80 mg/m2, on week 1, 4, 7 adjuvant chemotherapy: paclitaxel 175mg/m2 + cisplatin 75mg/m2, every 21 days for 4 cycles radiotherapy: IMRT

induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64

induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64

69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume

IMRT

Li Gao, MD

The purpose of this study is to determine whether Intensity-modulated radiation therapy (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin and paclitaxel) is feasible and effective than current standard treatment for high-risk locally advanced NPC patients.

Meta-analysis showed chemotherapy when combined with conventional radiotherapy in locally advanced naso-pharyngeal carcinoma can improve 5-year overall survival with 6%, and beyond all concurrent chemotherapy with cisplatin benefits most. However, from Lin's (Lin JC, 2004) study, locally advanced NPC with high risk factors can not benefit from conventional concurrent chemoradiation. Failure pattern analysis revealed that local and distant failure accounted for 50% respectively. Large-scale data has demonstrated that with IMRT, local control can achieve 90%. Previous studies showed inductive chemotherapy can decrease distant metastasis. We need more effective and stronger chemotherapy, and we still need to testify concurrent chemotherapy combined with inductive chemotherapy.

A prospective trial would thus provide valuable information to help physicians and patients more precisely identify the feasibility and effectiveness of inductive + concurrent chemotherapy combined with IMRT for high-risk locally advanced NPC.

The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

Phase 2 Study of Inductive Plus Concurrent Chemoradiation Versus Concurrent Plus Adjuvant Chemoradiation for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

Chinese Academy of Medical Sciences

Professor

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Micronutrients

Gemcitabine

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Folfirinox

Patients will receive FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m\^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease will be offered surgical exploration.

Starting dose levels as following:

Oxaliplatin 85mg/m2 intravenously over 120 minutes on day 1. Irinotecan 180mg/m2 intravenously over 90 minutes on day 1. NOTE: patients homozygous for the UGT1A1 (TA)7 promoter allele will be treated at an initial lower dose 140mg/m2 (please see Section 6.3.a) Leucovorin 400mg/m2 intravenously over 90 minutes on day 1. 5FU 400mg/m2 as bolus intravenous injection following leucovorin on day 1. 5FU 2,400mg/m2 infused intravenously as a continuous infusion over 46 hours following the bolus 5FU, beginning on day 1.

FOLFIRINOX

Intensity-modulated radiotherapy (IMRT)

Patients without metastatic disease will be offered surgical exploration.

Surgical Exploration

Mark Zalupski, MD

The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to address local disease, will achieve a significant improvement R0 resection (Radiation oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and enhance disease free and overall survival in this patient population.

Gemcitabine has been the cornerstone of systemic therapy for pancreas cancer over this past decade. Recently, a combination of 5-fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) was reported to have significant efficacy in advanced pancreatic cancer. Preclinical data suggests synergy between irinotecan and 5FU as well as between oxaliplatin and 5FU. Results of a phase II trial in advanced disease were reported in 2005 demonstrating a 26% confirmed response rate and median overall survival of 10.2 months. A follow-up phase III trial comparing FOLFIRINOX with gemcitabine for patients \<75 years of age with advanced pancreatic cancer was presented at ASCO 2010 revealing improvement in PFS (6.4 vs 3.3 months, p=\<.0001) and improved disease control rate (CR+PR+SD) (70.2% vs 50.9%, p=.0003). The most notable result was an impressive improvement in median overall survival with FOLFIRINOX compared to gemcitabine (11.1vs 6.8 months, p-value = \<.0001, HR=.57). The main toxicity was grade 3/4 neutropenia (45.7% vs 18.7%, p=.0001) and increased risk of febrile neutropenia (5.4% vs 0.6%, p=.009)31.

A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients

A Phase II Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients With Borderline Resectable Pancreatic Cancer

To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

To estimate progression-free survival as a function of time from study enrollment. Progression is defined as at least a 20% increase in the LD (longest diameter) of the primary lesion or the appearance of one or more new lesions

To estimate overall survival as a function of time from study enrollment.

University of Michigan Rogel Cancer Center

Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m\^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.

Study Treatment

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Mark Zalupski, M.D.

The Percentage of Patients That Underwent an R0 Resection

Median Progression-free Survival Time

Median Overall Survival Time

IMRT With FDR Gemcitabine

Nutritional and Metabolic Diseases

Diabetes Mellitus

Carcinoma, Hepatocellular

Metabolic Diseases

Glucose Metabolism Disorders

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month

Trans-catheter embolization (TAE) will be given once per month

p53 gene therapy

Trans-catheter embolization

Yuewei Zhang, MD, Ph D

Gui Gao, MD, Ph D

An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).

It was found in the treatment of HCC using p53 gene therapy that the concurrent diabetes was controlled as well. The objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. This is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. The study endpoints for anti-diabetic role are fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (A1C) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.

p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

In 60 days after starting study treatment

overall survival will be follow up to 2 years. Time to an event (death), or censored status (lost of follow up, withdrawal from the study, or still alive on 2 years) will be recorded. OS will be estimated using Kaplan-Meier method.

PFS will be follow up to 2 years. Time to an event (progression or death) or censored status (lost of follow up, withdrawal from the study, or still alive and no progression on 2 years). Assessment of progression will follow RECIST standard Version 1.1. PFS will be estimated using Kaplan-Meier method.

from starting treatment until 60 days treatment

Shenzhen SiBiono GeneTech Co.,Ltd

Acute Graft Versus Host Disease

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Docetaxel

Carboplatin

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Immunoglobulins

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Standard dose-dense Adriamycin and Cyclophosphamide (ddAC) chemotherapy and concurrent radiation therapy (RT)

Standard Adriamycin and Cyclophosphamide (AC) chemotherapy and concurrent radiation therapy

Standard Taxotere, Carboplatin and Herceptin (TCarbo H) chemotherapy and concurrent radiation therapy

Standard Taxotere, Adriamycin and Cyclophosphamide (TAC) chemotherapy with concurrent radiation therapy

Standard Taxotere and Cyclophosphamide (TC) chemotherapy with concurrent radiation therapy

4 cycles of Standard Dose-Dense Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).

Standard Dose Dense Doxorubucin and Cyclophosphamide

4 cycles of Standard Dose Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).

Standard Doxorubucin and Cyclophosphamide

6 cycles of Standard Docetaxel, Carboplatin and Herceptin chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).

Standard Docetaxel, Carboplatin, and Herceptin

3 cycles of Standard Docetaxel, Doxorubucin and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).

Standard Docetaxel, Doxorubucin and Cyclophosphamide

4 cycles of Standard Docetaxel and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).

Standard Docetaxel and Cyclophosphamide

Richard Zellars, M.D.

Amit Shah, M.D.

Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT when compared to radiation alone. However there is little data on how sequencing or timing of these therapies with respect to one another affect outcome. As a result there is no consensus about the optimal combination. There are real and potential benefits to concurrent chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall treatment program; and 3) may also improve local control via chemo-sensitization of residual cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with PBI delivered concurrently with various chemotherapy regimens.

1. Partial Breast Irradiation with concurrent chemotherapy (various regimens. Subjects will receive Segmental Mastectomy (Lumpectomy)
2. Medical Oncology Evaluation
3. Consent/Registration Pre-RT evaluation
4. Simulation/Treatment Planning
5. Chemo-Radiation Therapy:

   ddAC, Std AC, TAC, TC, TCH or TH Concurrent with PBI - (270 cGy per fraction for 15 fractions). RT may start up to 7days prior to C1D1, but no later than 7 days after C1D1 (+/- 7 days of C1D1 radiation may start)
6. Further chemotherapy, hormonal therapy or biologic therapy at the medical oncologist's discretion
7. F/U Schedule

Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens

"A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"

Acute Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:

0= no change; 1= follicular, fain or dull erythema/epilation/dry/desquamation/decreased swelling; 2= tender or bright erythemal patchy moist desquamation/moderate edema; 3= confluent moist desquamation other than skin folds, pitting edema; 4= ulceration, hemorrhage, necrosis.

Late Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:

0= none; 1= slight atrophy, pigmentation change, some hair loss; 2= patchy atrophy, moderate telangiectasias, total hair loss; 3= marked atrophy, gross telangiectasias; 4= ulceration

Subcutaneous tissue toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:

0= none; 1= slight induration (fibrosis) and loss of subcutaneous fat; 2= moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction; 3= severe induration and loss subcutaneous tissue; field contracture \>10% linear reduction; 4= necrosis

Number of participants with Poor, Fair, Good, or Excellent cosmetic effect after PBIC. Cosmetic effect will be graded by the investigator and participant as specified by the grading criteria in the Study Protocol (grading criteria description too large for this field).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer	NCT01413828	Breast Cancer	concurrent sequential	18 Years - 70 Years	Peking Union Medical College Hospital
Concurrent Xeloda and Radiotherapy for Bone Metastases	NCT00192777	Solid Tumors Bone Metastases	Xeloda External Beam R...	18 Years -	Rambam Health Care Campus
Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer	NCT01413828	Breast Cancer	concurrent sequential	18 Years - 70 Years	Peking Union Medical College Hospital
The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT	NCT01797900	Nasopharyngeal ...	Cisplatin Paclitaxel IMRT	18 Years - 70 Years	ChineseAMS
A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients	NCT01661088	Pancreatic Canc...	FOLFIRINOX Intensity-modul... Surgical Explor...	18 Years -	University of Michigan Rogel Cancer Center
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma	NCT02561546	HCC Diabetes	p53 gene therap... Trans-catheter ...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma	NCT02561546	HCC Diabetes	p53 gene therap... Trans-catheter ...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens	NCT00681993	Breast Cancer	Standard Dose D... Standard Doxoru... Standard Doceta... Standard Doceta... Standard Doceta...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for concurrent

Every month we try and update this database with for concurrent 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 concurrent

Every month we try and update this database with for concurrent 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 concurrent 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.