Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Gemcitabine

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses

Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses

Andreas du Bois, MD, PhD

J. Herrstedt

E. Pujade-Lauraine, MD, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

OBJECTIVES:

* Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.
* Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.
* Compare toxic effects of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
* Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo interval debulking surgery.

Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.

Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.

Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer

A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV

Survival time is calculated from the date of enrollment into the study until the date of death from any cause

The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

GERCOR - Multidisciplinary Oncology Cooperative Group

AGO Study Group

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Anti-Infective Agents

Trastuzumab

Cyclophosphamide

Docetaxel

Epirubicin

Pertuzumab

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Luminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer

Luminal breast cancer (HER2-, with 1-3 lymph nodes)

starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w,6 cycles

starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w ,6 cycles

Nab paclitaxel

90 mg/m2, d1, q3w ,4 cycles ,followed by docetaxel

600 mg/m2, d1, q3w × 4 cycles followed by docetaxel

90 mg/m2,d1, q2w × 4 cycles followed by nab-paclitaxel

600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel

Yiding CHEN

Huihui CHEN

Yiding Chen

Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.

At present, the treatment of early-stage breast cancer is mainly surgical, supplemented by chemotherapy, endocrine therapy, radiotherapy, targeted therapy and other comprehensive treatment methods, through the use of a variety of comprehensive and individualized treatment plans led to a significant improvement in the quality of life and survival of breast cancer patients. Systematic adjuvant therapy after surgery is also gaining increasing attention, with a large number of randomized clinical trials worldwide . The effectiveness of adjuvant therapy in reducing the recurrence of breast cancer and improving survival has been demonstrated in a number of randomized clinical trials worldwide. Adjuvant therapy after surgery is recommended in NCCN guidelines, ESMO, St. Gallen and other guidelines or expert consensus.

The use of albumin paclitaxel in the postoperative adjuvant treatment of breast cancer has been reported overseas, and a phase II clinical study published in 2017 investigated the tolerability and feasibility of dose dense doxorubicin combined with cyclophosphamide followed by nab-paclitaxel (AC-nP) chemotherapy in patients with high-risk early-stage breast cancer in adjuvant treatment. The results suggested that this regimen was well tolerated, with an incidence of granular deficiency with fever 5 of 2%, suggesting the safety of weekly treatment with nab-paclitaxel.

Another study evaluated the safety of dose-dense AC-nP regimens in women with high-risk breast cancer. Enrolled patients received 4 cycles of AC (every 2 weeks) followed by nab-P (every 2 weeks). The most common eventual adverse reaction was peripheral neuropathy, although approximately 80% of patients were grade 1-2, and the patient's neuropathy gradually improved after the end of treatment. This suggests that in early breast cancer, the use of dose-dense AC followed by nab-P is feasible with predictable AEs .

In summary, studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aim to conduct a prospective, randomized, open-label, multi-center clinical study to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.

A Study for the Adjuvant Treatment of Breast Cancer

A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer

Second Affiliated Hospital, School of Medicine, Zhejiang University

Digestive System Diseases

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Immunomodulating Agents

Chlorotrianisene

DC-TC+GM-CSF

Chengwei Chen

Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection and TACE Therapy will be evaluated.

The study is a single center,open label trial. To obtain safety information on toxicities and adverse events attributable to the subcutaneous injections of autologous dendritic cells incubated with irradiated autologous tumor stem cells and suspended in GM-CSF in patients with HCC.

Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

The number of adverse events along with the results of vital signs measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of DC-TC.

No.85 Hospital, Changning, Shanghai, China

China Cell Technology Ltd.

Cellular Biomedicine Group Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer	NCT00052468	Fallopian Tube ... Ovarian Cancer	TCG TC	18 Years -	AGO Study Group
A Study for the Adjuvant Treatment of Breast Cancer	NCT05420467	Breast Cancer	Docetaxel Carboplatin Trastuzumab Pertuzumab Nab paclitaxel Epirubicin Cyclophosphamid... Docetaxel Epirubicin Cyclophosphamid... Nab paclitaxel Cyclophosphamid...	18 Years -	Second Affiliated Hospital, School of Medicine, Zhejiang University
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy	NCT01828762	Primary Hepatoc...	DC-TC+GM-CSF	18 Years - 80 Years	Cellular Biomedicine Group Ltd.
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy	NCT01828762	Primary Hepatoc...	DC-TC+GM-CSF	18 Years - 80 Years	Cellular Biomedicine Group Ltd.

Spots Global Cancer Trial Database for tc

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

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