A Multicenter Trial of Benefits of Adding Post-surgery Chemotherapy for Cervical Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Radiation: Radiotherapy Drug: Cisplatin Drug: Paclitaxel+Cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter Trial of Benefits of Adding Chemotherapy as the Adjuvant Post-surgery Therapy for Cervical Cancer With Adverse Pathological Prognostic Factors |
- distant metastasis free survival,disease free survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 990 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Radiotherapy
|
Radiation: Radiotherapy
External irradiation 50Gy/5 weeks
|
|
Experimental: B
Concurrent chemoradiation: External beam radiation with concurrent weekly platinum chemotherapy |
Radiation: Radiotherapy
External irradiation 50Gy/5 weeks
Cisplatin 40mg/m2 every week during external irradiation
|
|
Experimental: C
Sequence chemotherapy and radiotherapy: 2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation |
Radiation: Radiotherapy
External irradiation 50Gy/5 weeks
Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with newly histologically confirmed cervical carcinoma
- Original clinical stage must be Ib~IIa （FIGO）
- Age between 18-65
- With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
- More than 3 months survival is to expect
- Patients must give signed informed consent
Exclusion Criteria:
- The presence of uncontrolled life-threatening illness
- Receiving other ways of anti-cancer therapy
- Residual tumor which can not be removed in the surgery
- 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
- Receive the external pelvic irradiation before the surgery
Contacts and Locations| Contact: Jihong Liu, Ph.D. | 86-20-8734-3102 | Liujih@mail.sysu.edu.cn |
| Contact: He Huang, Ph.D. | 86-20-8734-3104 | huangh@sysucc.org.cn |
| China, Guangdong | |
| Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Jihong Liu, Ph.D. 86-20-87343102 Liujih@mail.sysu.edu.cn | |
| Contact: He Huang, Ph.D. 86-20-87343104 huangh@sysucc.org.cn | |
| Study Chair: | Jihong Liu, Ph.D. | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Jihong Liu, Ph.D. Professor, Sun Yat-sen University Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00806117 History of Changes |
| Other Study ID Numbers: | 2008049 |
| Study First Received: | December 8, 2008 |
| Last Updated: | August 2, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-sen University:
|
Cervical cancer Concurrent chemoradiation Randomized controlled clinical trials |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Cisplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013