Cervical Cancer, Toxicity Due to Radiotherapy
Conditions
Keywords
Cervical cancer, postoperative risk factor, 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.
Interventions
RADIATIONRadiation
Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.
DRUGcisplatin（DDP） weekly
concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation
concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation
Sponsors
Mei Shi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 5-years |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival | 5 years |
| acute adverse events | 3 months |
| chronic adverse events | 3 years |
Countries
China
Contacts
Primary ContactMei Shi, MD.PhD
Outcome results
None listed