Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks

Treatment will be continued until disease progression or unacceptable toxic effects.

D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks Treatment will be continued until disease progression or unacceptable toxic effects.

docetaxel plus Cisplatin

Cisplatin plus weekly docetaxel as first-line chemotherapy in metastatic salivary gland cancer patients : a multicenter phase II study

Preclinically, paclitaxel and docetaxel have demonstrated activity against salivary gland cancers1. Phase II trial of single-agent paclitaxel2, conducted by Eastern Cooperative Oncology Group in 45 patients with advanced SGC. Eight partial responses were observed among the 31 patients with mucoepidermoid carcinoma (MEC) or adenocarcinoma, but no responses were identified in the 14 patients with ACC. Based on its impressive anti-tumor activity in patients with head and neck cancer, especially in squamous cell carcinoma, Ragusa et al.3 evaluated the activity of docetaxel in 4 patients with high grade MEC of the major salivary glands. The treatment was well tolerated, and there was complete response in two and partial response in the other two patients.

However, myelosuppression is one of the serious concerns with every 3 week schedule of docetaxel administration, especially in older patients. Alternatively, a weekly dosing of docetaxel has been reported to reduce toxicity and Investigator previously reported weekly docetaxel and cisplatin chemotherapy in recurrent or metastatic nasopharyngeal cancer demonstrated high response rate with modest toxicities4. So Investigator planned this phase II study to evaluate the efficacy and safety of cisplatin plus weekly docetaxel in patients with metastatic salivary gland cancer.

Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study

To evaluate the effectiveness of regimen. The overall response rate will be measured by RECIST v1.1.

Overal survival defined by date of all-cause mortality from date of IP administration will be calculated.

It is measure of the period of survival without disease progression.

Adverse event will be evaluate using CTCAE V.4.0

Samsung Medical Center

professor

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).

All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week).

cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks

Docetaxel plus cisplatin

radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)

radiotherapy

The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.

Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。

From the date of randomization until the date of death

Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0

Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months.

The Second People's Hospital of Huai'an

lian shui county People's Hospital

xuyi People's Hospital

Chinese People's Liberation Army No. 82 Hospital

Huai'an First People's Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation

concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation

2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation

Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.

Radiation

concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation

cisplatin（DDP） weekly

concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation

docetaxel plus cisplatin

adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation

Mei Shi, MD.PhD

Mei Shi, MD

Li-Chun Wei, M.D.,Ph.D

The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study	NCT05008237	Salivary Gland ...	docetaxel plus ...	20 Years -	Samsung Medical Center
Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma	NCT03600831	Esophageal Squa...	Docetaxel plus ... radiotherapy	18 Years - 70 Years	Huai'an First People's Hospital
Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer	NCT01999933	Cervical Cancer Toxicity Due to...	Radiation cisplatin（DDP） ... docetaxel plus ... docetaxel plus ...	18 Years - 70 Years	Air Force Military Medical University, China

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