Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Pemetrexed

Cisplatin

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Among TS expression positive patients, some will be randomized to Gem/cis therapy

Among patients with TS+, randomised to Pem/cis chemotherapy

Among patients with TS-, some will be randomised to Pem/cis Tx arm

Among patients with TS-, some will be randomised to Gem/Cis Tx arm

Gemcitabine 1000mg/m2 D1, D8 \& cisplatin 70mg/m2 D1 every 3 weeks

Gemcitabine plus cisplatin

Pemetrexed 500mg/m2 \& cisplatin 70mg/m2 D1 every 3 weeks

pemetrexed plus cisplatin

pemetrexed 500mg/m2 \& cisplatin 70mg/m2 every 3 weeks

Myung-Ju Ahn, Pf

Myung-Ju Ahn, M.D., Ph.D.

Jong-Mu Sun, M.D., Ph.D.

This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).

Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression

A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer

To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value

Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients

Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients

Samsung Medical Center

Vinorelbine

Tubulin Modulators

Antimitotic Agents

Zactima (ZD6474)

Vinorelbine plus cisplatin

Clinical Sciences & Operations

To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Genzyme, a Sanofi Company

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

S-1 plus cisplatin combination chemotherapy

Gemcitabine plus Cisplatin combination chemotherapy

S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks

S-1 plus cisplatin

Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks

Gemcitabine plus Cisplatin

MJ Kang, MD, MSc

To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.

Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma

Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer

progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.

Response to chemotherapy will be assessed using RECIST 1.0 criteria.

Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0. The types of toxicities and the proportions of patients who experience each toxicity will be described.

Overall survival is calculated from the date of enrollment to the date of death from any cause.

Asan Medical Center

Associate professor

Symptoms and General Pathology

Neoplasm Metastasis

Cholangiocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Capecitabine

Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks

Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks

Baek-Yeol Ryoo, MD

There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis

Proportion of patients without disease recurrence after 2 years

Median time point that 50% of study patients recur

Median time point that 50% of study patients is alive

Bundang CHA Hospital

Seoul St. Mary's Hospital

Severance Hospital

Professor

Carcinoma, Transitional Cell

Transitional Cell Carcinoma

Tislelizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

GC plus Tislelizumab Participants receive GC (Gemcitabine plus cisplatin), in combination with Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 6 months after excision of the primary lesion.

Intervention/treatment： Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W

Biological: GC GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks

Tislelizumab Participants receive Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 6 months after excision of the primary lesion.

Intervention/treatment： Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W

Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma

primary focal resection plus lymph node dissection

GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks

Qikai Wu

Pengchao Li

Qiang Lu, PhD

Pengchao Li, PhD

Qiang Lv

treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-programmed cell death 1(PD-1) for Oligometastasis of urothelial carcinoma.

The study is designed to demonstrate that Whether the perioperative comprehensive treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-PD-1 can prolong the overall survival of patients, narrow the range of metastatic lesions and improve the quality of life of patients.

Compared with patients with extensive metastasis, 2-year tumor-specific survival and overall survival of patients with oligometastatic bladder cancer were significantly increased (53.3% vs 16.1%)；(51.9% vs. 15.4%).Gemcitabine plus cisplatin (GC) regimen has been shown to bring clinical benefits in neoadjuvant therapy of metastatic UC（urothelial carcinoma）.

PD-1 inhibitors have been widely used in urothelial carcinoma in recent years, and positive data have been obtained in both advanced patients and neoadjuvant patients.

If successful in this trial, it will serve to provide a therapeutic alternative for this patient who have oligometastasis of urothelial carcinoma.

Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma

Trials of Primary Excision Combined With Preoperative Neoadjuvant Therapy and Adjuvant Therapy Was Used as a First-line Comprehensive Therapy for Oligometastasis of Urothelial Carcinoma（UC）.

the percentage of patients who die of any cause within first year of treatment

time between the first objective recording of PD(progressive disease) or death from any cause (whichever occurs first) from random group solstice

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression	NCT01401192	Non-small Cell ...	Gemcitabine plu... pemetrexed plus... pemetrexed plus... Gemcitabine plu...	18 Years -	Samsung Medical Center
Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC	NCT00496275	Non Small Cell ...	Zactima (ZD6474... Vinorelbine plu... Gemcitabine plu...	18 Years -	Sanofi
Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC	NCT00496275	Non Small Cell ...	Zactima (ZD6474... Vinorelbine plu... Gemcitabine plu...	18 Years -	Sanofi
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression	NCT01401192	Non-small Cell ...	Gemcitabine plu... pemetrexed plus... pemetrexed plus... Gemcitabine plu...	18 Years -	Samsung Medical Center
Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma	NCT01375972	Metastatic Bili...	S-1 plus cispla... Gemcitabine plu...	18 Years -	Asan Medical Center
Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma	NCT03079427	Cholangiocarcin... Biliary Tract C... Adjuvant Chemot... Capecitabine Gemcitabine Cisplatin	Gemcitabine plu... Capecitabine	19 Years -	Asan Medical Center
Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma	NCT04570410	Bladder Urothel...	primary focal r... Tislelizumab Gemcitabine plu...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University

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