Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999933
• Other study ID #: XJFL-201309-CCPOSTOP
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 26, 2013
• Last updated: December 2, 2013
• Start date: November 2013
• Est. completion date: November 2018

Study information

• Verified date: November 2013
• Source: Fourth Military Medical University
• Contact: Mei Shi, MD.PhD
• Phone: +86-029-84775425
• Email: mshifmmu[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 Years to 70 Years

• Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy

• Accepted radical hysterectomy 3-4 weeks before

• Karnofsky score >70

• Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.

• Examination results showed no radiation or chemotherapy contraindication

• Willing to accept treatment

• Ability to comply with trial requirements

Exclusion Criteria:

• Postoperative residual

• Postoperative recurrence or metastasis

• Without lymph node dissection

• Postoperative pathology showed aortic lymph node metastasis

• Examination results showed radiotherapy contraindications

• No indications for radiotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Toxicity Due to Radiotherapy
• Uterine Cervical Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Mei Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5-years	No
Secondary	disease-free survival		5 years	No
Secondary	acute adverse events		3 months	Yes
Secondary	chronic adverse events		3 years	Yes