Clinical trial NCT01999933: Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer
Official title: Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cervical Cancer
Toxicity Due to Radiotherapy
Keywords: Cervical cancer
postoperative risk factor
treatment
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 5-years
Secondary outcomes:
measure: disease-free survival
timeFrame: 5 years
measure: acute adverse events
timeFrame: 3 months
measure: chronic adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: department of radiation oncology
name: Mei Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: