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

Concurrent definitive chemoradiation incorporating intensity-modulated radiotherapy followed by adjuvant chemotherapy in high risk locally advanced cervical squamous cancer: A phase II study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN53385401

Enrollment

Registered

2021-10-25

Start date

2010-06-01

Completion date

Unknown

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk locally advanced cervical squamous cancer Cancer Cervical cancer

Interventions

Radiotherapy consists of intensity-modulated external-beam radiotherapy and brachytherapy. IMRT is delivered with dynamic multileaf collimators using 6 MV photon beams. Clinical target volume (CTV) is

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Patterns of failure measured in terms of locoregional recurrence (LRR) and distant metastasis (DM) at the time of first evidence of relapse. 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.	—

Measure

Time frame

1. Patterns of failure measured in terms of locoregional recurrence (LRR) and distant metastasis (DM) at the time of first evidence of relapse. 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.

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Countries

China

Contacts

Public ContactGongyi Zhang

samuel000816@sina.com+86-010-87787210

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026