Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.

Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.

Chinese Traditional Medicine

Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine

Metronimic chemotherapy plus Chinese Traditional Medicine

Capecitabine 300mg/m2, twice a day, everyday

Metronimic chemotherapy

The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus Chinese Traditional Medicine.

In this Prospective, open-label, randomised controlled trial, the investigators will recruit 159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This treatment regimen will be continued until progression, death, or an unacceptable adverse event.

The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.

Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer

from randomising to progression, death, unacceptable AE

Ruijin Hospital

associate chief physician, Department of Oncology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Trastuzumab

Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

1. Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by;
2. Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks

Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide

The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.

Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)

Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer

INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%

Efficacy will be assessed by:

1. Tumor measurements using MRI of the Breast
2. Pathologic complete response
3. Progression-free survival
4. Overall survival

Fundação Faculdade de Medicina

Instituto do Cancer do Estado de São Paulo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer	NCT02575378	Metastatic Colo...	Metronimic chem... Metronimic chem...	18 Years - 75 Years	Ruijin Hospital
Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)	NCT01329640	Locally Advance...	Drug: Paclitaxe...	18 Years -	Instituto do Cancer do Estado de São Paulo
Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)	NCT01329640	Locally Advance...	Drug: Paclitaxe...	18 Years -	Instituto do Cancer do Estado de São Paulo

Spots Global Cancer Trial Database for metronimic chemotherapy