A study to assess the safety and efficacy of chemotherapy and surgery in treatment of cervical cancer
| ISRCTN | ISRCTN24104022 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24104022 |
- Submission date
- 11/07/2022
- Registration date
- 13/07/2022
- Last edited
- 23/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Although radical surgery and radiation therapy were feasible treatment plans for patients with locally advanced cervical cancer (LACC), the optimal treatment plan remained controversial. Neoadjuvant chemotherapy (NACT) followed by radical surgery has been widely used for patients with LACC to reduce tumor volume, improve the rate of resection and control the potential micro-metastasis. However, there has been no study reporting the effect of NACT with carboplatin-paclitaxel plan. Therefore we performed this retrospective study to investigate the clinical effects of NACT regiment carboplatin-paclitaxel.
Who can participate?
Adult females diagnosed with cervical cancer.
What does the study involve?
Retrospectively compare 5-year overall survival, 5-year overall survival and cumulative postoperative radiation rate between LACC patients who received NACT followed by PRS and patients who received PRS.
What are the possible benefits and risks of participating?
Benefits include potential exemption from radiation therapy and improvement of quality of life.
There are no risks of participating.
Where is the study run from?
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (China)
When is the study starting and how long is it expected to run for?
January 2018 to May 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof Zehua Wang
zehuawang@hust.edu.cn
Contact information
Principal Investigator
Jiefang Avenue #1277
Wuhan
430022
China
 ORCID ID |
0000-0001-6423-8219 |
|---|---|
| Phone | +86 027 85726993 |
| zehuawang@hust.edu.cn |
Study information
| Study design | Single-center retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Retrospective analysis of neoadjuvant chemotherapy on postoperative treatment in patients with cervical cancer |
| Study objectives | To investigate and analyze the effect of neoadjuvant chemotherapy on paraneouterine metastasis and postoperative treatment of cervical cancer |
| Ethics approval(s) | Approved 07/11/2018, Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (Hangkong Road, #13, Qiaokou District, Wuhan, China; +86 027 83691785; tongjilunli@163.com), ref: S452 |
| Health condition(s) or problem(s) studied | Feasibility of NACT in localized advanced cervical cancer patients |
| Intervention | The NACT group: FIGO(2009) IB2-IIA2 cervical cancer patients underwent carboplatin-liposomal paclitaxel chemotherapy followed by radical hysterectomy and pelvic lymphadenectomy. The PRS group: FIGO(2009) IB2-IIA2 cervical cancer patients underwent primary radical hysterectomy and pelvic lymphadenectomy. For NACT, carboplatin-paclitaxel carboplatin-liposomal paclitaxel regimen was used. Patients intravenously received paclitaxel at 135-175 mg/m² on the first day and carboplatin at an area under the curve (AUC) = 5 on the second day every 3 weeks. The number of NACT cycles ranged from 2 to 3. For radical hysterectomy, surgical procedures were performed according to the C type of the Querleu-Morrow classification. Systematic bilateral pelvic lymphadenectomy including the common iliac, external iliac, internal iliac, obturator regions, and parametric lymph nodes were removed. The follow up was performed according to the recommendations from National Comprehensive Center Network. The items mainly included gynaecological examination, vaginal stump cytological examination, pelvic ultrasound, and chest X-ray. |
| Intervention type | Mixed |
| Primary outcome measure | 5-year overall survival defined as the time from completion of operation to death or to the date of last contact. |
| Secondary outcome measures | 1. 5-year progression-free survival defined as the time from completion of operation to the first appearance of progressive disease or to the date of last contact 2. Cumulative postoperative radiation rate: use of radiation and the interval between surgery and radiation (adjuvant therapy or therapy after recurrence) were used to estimate the cumulative radiation during the follow-up |
| Overall study start date | 01/01/2018 |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 207 |
| Total final enrolment | 414 |
| Key inclusion criteria | 1. Primary malignant tumor of cervix confirmed by cervical biopsy 2. No other malignant tumors |
| Key exclusion criteria | 1. Cervical metastatic malignant tumor 2. Complicated with other malignant tumors 3. Patients undergoing surgery or pathological examination in other hospitals |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 01/01/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Wuhan
430022
China
Sponsor information
Hospital/treatment centre
Jiefang Avenue #1277
Wuhan
430022
China
| Phone | +86 027 85726300 |
|---|---|
| xhyykyc@163.com | |
| Website | https://www.whuh.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request zehuawang@hust.edu.cn |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/08/2022 | 23/08/2022 | Yes | No |
Editorial Notes
23/08/2022: Publication reference added.
12/07/2022: Trial's existence confirmed by Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology.
