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Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

NCT02595554UNKNOWNPHASE3INTERVENTIONAL

Summary

Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.

Key Facts

Lead Sponsor

Sun Yat-sen University

Enrollment

220

Start Date

2015-11-01

Completion Date

2020-12-01

Study Type

INTERVENTIONAL

Official Title

Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer

Interventions

Concurrent chemoirradiationPaclitaxelRadical SurgeryCisplatin

Conditions

Cervical Carcinoma Stage IIB

Eligibility

Age Range

18 Years – 60 Years

Sex

FEMALE

Inclusion Criteria:

* Patients with newly histologically confirmed cervical carcinoma
* Original clinical stage must be IIB （FIGO 2009）
* Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
* Age between 18-65
* Patients must give signed informed consent

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Investigator consider the patients can't finish the whole study
* With normal liver function test (ALT、AST\>2.5×ULN)
* With normal renal function test (Creatinine\>1.5×ULN)
* WBC\<4,000/mm3 or PLT\<100,000/mm3

Outcome Measures

Primary Outcomes

Disease free survival

Time frame: 5 years

Secondary Outcomes

Overall survival

Time frame: 5 years

Locations

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

Linked Papers

2020-06-09

Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study

Concurrent chemoradiotherapy is the first-line treatment for FIGO stage IIB cervical cancer. Neoadjuvant chemotherapy followed by radical surgery may provide another treatment option. To compare the therapeutic outcomes of neoadjuvant chemotherapy followed by surgery with cisplatin-based concurrent chemoradiotherapy for stage IIB cervical cancer. We hypothesize that the therapeutic effect of neoadjuvant chemotherapy combined with surgery and risk-adapted adjuvant treatment will be superior to that of concurrent chemoradiotherapy in stage IIB cervical cancer. Patients with stage IIB cervical cancer will be randomized 1:1 to neoadjuvant chemotherapy followed by surgery (Arm A) or concurrent chemoradiotherapy (Arm B). In arm A, patients will receive three cycles of paclitaxel and cisplatin followed by a type C radical hysterectomy and pelvic ±paraaortic lymphadenectomy. Patients showing progression after neoadjuvant chemotherapy will be referred to concurrent chemoradiotherapy. Adjuvant therapy will be recommended according to the presence of pathological risks. In Arm B, all patients will receive definitive concurrent chemoradiotherapy, including external beam pelvic radiotherapy combined with concurrent weekly cisplatin followed by brachytherapy. Patients between 18 and 60 years with histologically confirmed, untreated stage IIB cervical squamous carcinoma, adenocarcinoma, or adeno-squamous carcinoma. The primary endpoint is 2-year disease-free survival. An estimated sample size of 240 is required to fulfill the study objectives. As of February 2020, 115 eligible patients from four institutions have been enrolled. Enrollment is expected to be completed by December 2022. ClinicalTrials. gov identifier: NCT02595554.

Linked Investigators

Hua Tu