Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial

NCT05367206 | Recruiting Phase 3

• 1 other identifier: SunYat-sen University
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis.

Conditions

Cervical Cancer; Neoadjuvant Chemotherapy; Bulky Neoplasm

Keywords

cervical cancer; neoadjuvant chemotherapy; bulky neoplasm

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival ratio

  the time from study randomization to 3 years, the ratio for patients without disease progression nor death.

  up to 3 years

Study Arms (2)

NAC plus RCT

EXPERIMENTAL

two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation

Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

RCT

NO INTERVENTION

standard chemoradiation with weekly cispatin plus pelvic radiation

Interventions

Albumin-Bound Paclitaxel DRUG

260mg/m2 q3w \*2 circles

NAC plus RCT

Carboplatin DRUG

AUC 5-6 q3w \* 2 circles

NAC plus RCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix；
• FIGO (2018 International Federation of Gynecology and Obstetrics) stage IIIC with carcinoma \>4 cm in greatest dimension and/or lymph node \>2 cm in short axis at initial diagnosis.
• age 18 to 70 years；
• Eastern Cooperative Oncology Group performance status 0 to 2；
• adequate organ function.

You may not qualify if:

• \. not at initial diagnosis; 2. with other kind of tumor.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdone, 510000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Central Study Contacts

Junyun Li, M.D.

CONTACT

020-87343817; LIJUNY@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 10, 2022
• Study Start: March 14, 2022
• Primary Completion: March 31, 2024
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)