Clinical trial NCT01756170: Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
Official title: Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: cervical cancer
radiotherapy
postoperative therapy
chemotherapy
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.

Detailed description: Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. However, the treatment modality in patients with low-risk (lymph node negative) is still disputable. It is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.

Eligibility criteria: Inclusion Criteria:

* Undertaken radical hysterectomy with diagnosis of invasive cervical cancer (non-small cell type)
* Negative lymph node
* At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve involvement)
* Eastern Cooperative Oncology Group 0-2
* Expected life span over 6 months.
* No distant metastasis
* Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous history of chemotherapy or radiation
* Hypersensitive reaction to platinum/paclitaxel agent
* History of other cancer
* Concurrent systemic illness not appropriate for chemotherapy
* Active infection requiring antibiotics
* Pregnancy

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
Other outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 1 year
Locations:
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: the 1st Affiliated Hospital of Wenzhou Medical College
name: Congying Xie, MD
role: STUDY_DIRECTOR
References: