Evaluating the effectiveness of combining intensity-modulated radiotherapy technique and paclitaxel plus cisplatin chemotherapy into the treatment of high-risk inoperable cervical cancer

Not Applicable

Completed

• Conditions: High-risk locally advanced cervical squamous cancer; Cancer; Cervical cancer

• Registration Number: ISRCTN53385401
• Lead Sponsor: Cancer Hospital of Chinese Academy of Medical Sciences

Brief Summary

2021 Preprint results in https://doi.org/10.21203/rs.3.rs-620389/v1 (added 18/07/2022) 2022 Results article in https://doi.org/10.1186/s12885-022-10406-9 (added 17/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-01
• Study Start: 2021-10-25
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

1. Biopsy proven stage III-A- IV-A squamous cervical cancer or stage II-B disease with metastatic regional nodes.
2. Age 18-70 years
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =1
4.No previous history of chemotherapy or radiotherapy
5. Sufficient bone marrow, including leukocyte count =4,000/mm³, neutrocyte count =2,100/mm³, platelet count =100,000/mm³, hemoglobin =90 g/L.
6. Adequate renal and hepatic functions.
7. Normal cardiovascular function.

Exclusion Criteria

1. Patients with synchronous malignancies
2. Patients with distant metastases
3. Patients with known hypersensitivity to cisplatin or paclitaxel
4. Patients with poorly controlled medical conditions
5. Patients with previous chemotherapy or radiotherapy treatment.
6. Patients who were pregnant or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS) and overall survival (OS) are measured from the time of diagnosis to the time of first evidence of relapse or death from any cause. Patients without documented evidence of recurrence are censored at the date of last follow up visit. The cumulative survival rate is calculated with the Kaplan-Meier method using SPSS.

Secondary Outcome Measures

Name	Time	Method
1. Patterns of failure measured in terms of locoregional recurrence (LRR) and distant metastasis (DM) at the time of first evidence of relapse.<br>2. Toxicities are measured according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Scheme every week during the treatment, every 3-months after the completion of treatment for 2 years, and every 6 months during the next 3 years.