NCT03308591

Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients

Completed Phase 3 Last updated 31 October 2024

What this trial tests

Phase 3 trial testing NACT in Uterine Cervical Neoplasm in 774 participants. Completed in 1 February 2022.

Timeline

11 January 2016

Primary endpoint
1 February 2022

1 February 2022

Quick facts

Lead sponsor	Huazhong University of Science and Technology
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	774
Start date	11 January 2016
Primary completion	1 February 2022
Estimated completion	1 February 2022
Sites	1 location across China

Drugs / interventions tested

• NACT — full drug profile →
• RT+PLND
• Adjuvant chemotherapy — full drug profile →

Conditions studied

• Uterine Cervical Neoplasm — all drugs for Uterine Cervical Neoplasm →
• Cervical Cancer — all drugs for Cervical Cancer →
• Uterine Cervical Cancer — all drugs for Uterine Cervical Cancer →

Sponsor

Huazhong University of Science and Technology

Who can join

Under 65, female only, with Uterine Cervical Neoplasm or Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the function of ovary, cause endocrine dyscrasia and the sexual function of vagina. So we want to study whether neoadjuvant chemotherapy without radiotherapy will achieve the same outcome compared with traditional therapy including radiotherapy. So we randomly divide IB2 and IIA2 stage cervical cancer patients into two groups. The neoadjuvant chemotherapy group will receive two courses of chemotherapy basically composed of platinum, and then undergo surgery, after that, doctors will add more courses of chemotherapy according to the situations of the patients, including whether the patients have the adverse prognostic factors. The control group will undergo surgery directly, and then receive chemotherapy and radiotherapy at the same time. Then we will compare the outcomes of these two groups, and analyze the therapeutic effect, the impact on survival rate and the effect on improving the living quality of patient from two groups. All the outcomes will be fed back to clinical doctors and instruct them to choose better treatment for patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant chemotherapy for patients with international federation of gynecology and obstetrics stages IB3 and IIA2 cervical cancer: a multicenter prospective trial.
   Hu Y, Han Y, Shen Y, Chen J, et al · · 2022 · cited 14× · PMID 36471257 · DOI 10.1186/s12885-022-10355-3
2. Efficacy Analysis of Neoadjuvant versus Adjuvant Cisplatin-Paclitaxel Regimens for Initial Treatment of FIGO Stages IB3 and IIA2 Cervical Cancer.
   Tao W, Wang W, Zhai J, Guo L. · · 2023 · cited 3× · PMID 38062672 · DOI 10.12659/msm.940545
3. Neoadjuvant Chemotherapy for Patients with International Federation of Gynecology and Obstetrics Stages IB3 and IIA2 Cervical Cancer: A Multicenter Prospective Trial
   Hu Y, Han Y, Shen Y, Chen J, et al · · 2022 · DOI 10.21203/rs.3.rs-1946474/v1