Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Antimetabolites

GP (gemcitabine and cisplatin combination)

Eribulin 1.4mg/m2, IV , D1, D8；Cisplatin 75 mg/m2, IV，D1

Eribulin,cisplatin

Gemcitabine 1250 mg/m2, IV , D1, D8； Cisplatin 75 mg/m2, IV, D1

Gemcitabine,cisplatin

Jian Zhang, MD,PhD

Yiqun Du, MD,PhD

Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer.

A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer

Fudan University

Associate chief physician

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy

Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone

Induction chemotherapy: Patients receive 1000 mg/m2 gemcitabine intravenously on day 1and day 8， 80mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.

Gemcitabine,Cisplatin

IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were \> 66 Gy to the primary tumor and \> 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.

Intensity-modulated radiation therapy (IMRT)

Concurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.

Wei Jiang, PhD

Bin Zhang, MD

In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved as the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.

Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were \> 66 Gy to the primary tumor and \> 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were \> 66 Gy to the primary tumor and \> 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 3 cycles during IMRT.

Induced Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

Progression-free survival is from randomization to first disease progression \[local recurrence and/or distant metastasis\] or death from any cause

Overall survival is from randomization to death of any cause or last follow-up

Locoregional failure-free survival is from randomization to locoregional progression

Distant failure-free survival is from randomization to first distant metastasis

Objective response rate is the percentage of patients achieving complete response (CR) and partial response (PR) according to RECIST 1.1 criteria.

Wuzhou Red Cross Hospital

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Lingshan people's Hospital

Laibin People's Hospital

Nationalities Hospital of Guangxi Zhuang Autonomous Region

Wei Jiang

Principal Investigator

Carboplatin

GC (gemcitabine and carboplatin combination)

Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1

Gemcitabine 1000 mg/m2, IV drip 30 minutes, D1, D8 Carboplatin AUC 2, IV drip 120 minutes, D1

Gemcitabine,carboplatin

Xichun Hu, MD, PhD

Biyun Wang, MD

Xichun Hu, MD,PhD

Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast Cancer (TNBC)

A Phase II, Single-center, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Carboplatin (GC) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer.

A Phase II, Single-center, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Carboplatin (GC) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)	NCT04517292	Breast Cancer	Eribulin,cispla... Gemcitabine,cis...	18 Years - 70 Years	Fudan University
Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma	NCT05527470	Nasopharyngeal ...	Gemcitabine,Cis... Intensity-modul... Cisplatin	18 Years - 65 Years	Guilin Medical University, China
Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast Cancer (TNBC)	NCT02341911	Breast Cancer	Gemcitabine,cis... Gemcitabine,car...	18 Years - 70 Years	Fudan University
Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)	NCT04517292	Breast Cancer	Eribulin,cispla... Gemcitabine,cis...	18 Years - 70 Years	Fudan University

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