Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All 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

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.

During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.

After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;

The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.

docetaxel 75mg/m2, d43,d64.

standard chemoradiotherapy with weekly cisplatin.

Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.

Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.

in experimental group: cisplatin 60mg/m2, d1,d22;

concurrent chemotherapy with cisplatin

in experimental group: docetaxel 60mg/m2, d1,d22;

concurrent chemotherapy with docetaxel

external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.

pelvic radiotherapy

CT/MRI guided brachytherapy or x-ray guided brachytherapy

brachytherapy

cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64

adjuvant chemotherapy with cisplatin and docetaxel

mei shi, professor

ying zhang, doctor

Mei Shi, professor

Mei Shi, MM

Mei Shi, MD

The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.

The cervical cancer is the most common malignant gynecological tumor in the developing area. From 1999, the concurrent chemoradiotherapy has been established as the standard treatment for local advanced cervical cancer. The modern radiotherapy techniques, such as 3 dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical cancer. The recently clinical outcome showed that the 3 year local and regional control was more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and death, especially for the patient with pelvic lymph node metastasis, large volume of tumor and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant metastasis has become to be the topic of clinical investigation.

Dueñas-González A'［4］ study demonstrated that the 3 year progress free survival and distant metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant chemotherapy after CCRT has better DMFS and OS.

The aim of present study is to prospectively investigate the efficacy and safety of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.

Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer

Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer

Air Force Military Medical University, China

chair of department

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Neoplasms

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Concurrent chemoradiotherapy: IMRT was given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy.

IMRT is given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume.

Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT

Concurrent chemotherapy with cisplatin

Intensity modulated radiotherapy is a technique of radiotherapy.

Intensity modulated radiotherapy

Xiaodong Zhu, Doctor

Song Qu, Doctor

Ling Li, Master

The study is designed to compare Intensity Modulated Radiotherapy (IMRT) in combination with concurrent chemotherapy and IMRT alone in treatment of stage II nasopharyngeal carcinoma.

Nasopharyngeal carcinoma (NPC) is endemic in Southern China, Southeast Asia, the Arctic, and mid-East/North Africa. NPC prevalence is reported to be highest in southern China, where an average of 80 cases per 100,000 population are reported each year. It is both radiosensitive and chemosensitive. The National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) as standard treatment for NPC.

Recently, the technique of IMRT has become widely used in the treatment of nasopharyngeal carcinoma. The preliminary results showed that IMRT might improve the rate of local control and the quality of life in NPC. In a retrospective study (Ivan,2010), the result showed that IMRT without concurrent chemotherapy provides good outcome for patients with stage IIB NPC with acceptable toxicity. Another study showed that Comparing with IMRT alone, IMRT in combination with chemotherapy provided no significant benefit to locoregionally advanced NPC (Su,2011). With IMRT, it was unclear whether the additional of concurrent chemotherapy was essential for stage II nasopharyngeal carcinoma.

The investigators designed the present study to research the role of adding concurrent chemotherapy to intensity modulated radiotherapy in the treatment of stage II NPC. The primary endpoint is failure-free survival (FFS).The second endpoints were overall survival (OS),loco-regional failure-free survival (LFFS), distant metastasis failure-free survival (DMFS), and acute and late adverse events.

The Role of Adding Concurrent Chemotherapy to IMRT in the Treatment of Stage II Nasopharyngeal Carcinoma

Phase II Study Comparing Intensity Modulated Radiotherapy (IMRT) in Combination With Concurrent Chemotherapy and IMRT Alone for Stage II Nasopharyngeal Carcinoma

The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.

The time is calculated from the date of diagnosis to the date of patient death.

The time is calculated from the date of diagnosis to the date of a relapse of local or nodal tumors.

The side effects will be evaluated according to CTCAE V 3.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer	NCT02703961	Cervical Cancer	concurrent chem... concurrent chem... pelvic radiothe... brachytherapy adjuvant chemot...	18 Years - 60 Years	Air Force Military Medical University, China
The Role of Adding Concurrent Chemotherapy to IMRT in the Treatment of Stage II Nasopharyngeal Carcinoma	NCT02116231	Effects of Chem...	Concurrent chem... Intensity modul...	18 Years - 70 Years	Cancer Hospital of Guangxi Medical University
Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer	NCT02703961	Cervical Cancer	concurrent chem... concurrent chem... pelvic radiothe... brachytherapy adjuvant chemot...	18 Years - 60 Years	Air Force Military Medical University, China

Spots Global Cancer Trial Database for concurrent chemotherapy with cisplatin