Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Radiotherapy (Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1) + Sequential chemotherapy

Three dimensional conformal radiation therapy (3D-CRT) (Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30) + Concurrent chemotherapy (Gemcitabine(GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d) + Sequential chemotherapy

Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1

Intraoperative radiotherapy (IORT)

Sequential chemotherapy

Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30

Three dimensional conformal radiation therapy (3D-CRT)

Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d

Concurrent chemotherapy

Jianwei Zhang, Ph.D.

Shuisheng Zhang, M.D.

Chengfeng Wang, B.A.

The purpose of this study is to find the better radiation therapy between intraoperative radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).

The trial is funded by National High-tech R\&D Program (863 Program). The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of The First Affiliated Hospital of China Medical University Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant. Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 100 participants to take part in the trail. The investigators can recruit about 120 participants every year according to previous experiences, so the investigators should recruit at least for one years.

Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P \< 0.05.

IORT Versus CCRT for Pancreatic Cancer

Intraoperative Radiotherapy (IORT) Versus Concurrent Chemoradiotherapy (CCRT) for Pancreatic Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Director of Department of Abdominal Surgical Oncolgoy

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

Neoplastic Processes

Capecitabine

Vinorelbine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Simultaneous use of Vinorelbine and Capecitabine

Sequential use of Vinorelbine and Capecitabine

Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w

Vinorelbine and Capecitabine

Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w

XiChun Hu, MD, PhD

The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.

The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.

Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)

Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer

PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.

Safety and QOL were assessed every cycle(3 weeks per cycle) and during the follow up time, until 28 days after the last cycle.

TTP and OS were assessed every cycle(3 weeks per cycle) and during the follow up time, until the event occurs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IORT Versus CCRT for Pancreatic Cancer	NCT02981641	Pancreatic Canc...	Intraoperative ... Sequential chem... Three dimension... Concurrent chem...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IORT Versus CCRT for Pancreatic Cancer	NCT02981641	Pancreatic Canc...	Intraoperative ... Sequential chem... Three dimension... Concurrent chem...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)	NCT00629148	Breast Cancer Metastasis, Neo...	Vinorelbine and... Vinorelbine and...	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for sequential chemotherapy