Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Carcinoma

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

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Concurrent chemoirradiation:

External beam radiation with concurrent weekly platinum chemotherapy

Sequence chemotherapy and radiotherapy:

2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation

External irradiation 50Gy/5 weeks

* Lateral: 2 cm lateral to the bony margin of the pelvis
* Superior: Between L5 and S1
* Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy/4 weeks(positive vaginal margins only)

Radiotherapy (RT)

Cisplatin 40mg/m2 every week during external irradiation

Concurrent chemoirradiation (CCRT)

Paclitaxel 135\~175mg/m2 over 3 hours Cisplatin 60\~75mg/m2

Sequence chemotherapy and radiotherapy (SCRT)

Jihong Liu, Ph.D.

Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.

In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.

After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.

We have recruited 800 patients till November 2014.

After radical surgery, eligible patients with risk pathological factors were randomize to three groups.

Radiotherapy: Group A underwent 50 GY pelvic RT alone. Radiotherapy and drugs: Group B received concurrent weekly cisplatin and RT (CCRT).

Radiotherapy and drugs: Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles of chemotherapy (SCRT).

Comparison of Different Subsequent Treatments After Radical Surgery

Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma

Guangdong Provincial People's Hospital

First Affiliated Hospital, Sun Yat-Sen University

Shenzhen People's Hospital

Cancer Hospital of Guangxi Medical University

Sun Yat-sen University

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal 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

Fluorouracil

Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.

Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.

neoadjuvant chemotherapy plus concurrent chemoradiotherapy

Sumei Cao, Ph. D.

Sumei Cao, Ph. D

Minghuang Hong, MD

Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis.

In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.

A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Affiliated Cancer Hospital of Shantou University Medical College

the director of GCP

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Different Subsequent Treatments After Radical Surgery	NCT00806117	Cervical Cancer	Radiotherapy (R... Concurrent chem... Sequence chemot...	18 Years - 65 Years	Sun Yat-sen University
Comparison of Different Subsequent Treatments After Radical Surgery	NCT00806117	Cervical Cancer	Radiotherapy (R... Concurrent chem... Sequence chemot...	18 Years - 65 Years	Sun Yat-sen University
A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma	NCT00705627	Nasopharyngeal ...	neoadjuvant che...	18 Years - 60 Years	Sun Yat-sen University

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