Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

NCT05735145 | Recruiting Phase 3

• 1 other identifier: 124502004985979665
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. By comparing simultaneous intensity-modulated radiotherapy and chemotherapy combined with adjuvant chemotherapy and simultaneous intensity-modulated radiotherapy and chemotherapy alone, based on the 2018 FIGO staging The clinical efficacy of locally advanced cervical cancer further clarifies the role of adjuvant chemotherapy in locally advanced cervical cancer.

Conditions

Uterine Cervical Neoplasms; Chemoradiotherapy; Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  Refers to the time from randomization to the first occurrence of disease progression or death from any cause，whichever came first, assessed up to 1000 months

Secondary Outcomes (1)

• OS

  Refers to the time from randomization to death from any cause, assessed up to 1000 months

Study Arms (2)

concurrent chemoradiotherapy combined with adjuvant chemotherapy

EXPERIMENTAL

Adjuvant chemotherapy in patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy

Drug: paclitaxel combined with platinum

concurrent chemoradiotherapy

OTHER

Observation of patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy

Drug: paclitaxel combined with platinum

Interventions

paclitaxel combined with platinum DRUG

Adjuvant chemotherapy with paclitaxel combined with platinum

Also known as: Adjuvant chemotherapy with paclitaxel combined with platinum

concurrent chemoradiotherapy; concurrent chemoradiotherapy combined with adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: femal
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical cancer confirmed by histopathology incloud squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma
• FIGO stage IB3, IIA2, IIB-IVA patients in 2018
• Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect reached CR after treatment
• Aged 18-75 years
• PS score 0-1
• Serum hemoglobin \>=100\*10\^9/L, blood platelet \>= 100000/μL, absolute count of neutrophils\>=1500/μL; 7.Serum creatinine \<=1.5 UNL or creatinine clearance \>= 60 ml/min; 8.Serum bilirubin \<=1.5 UNL, AST (SGOT) and ALT (SGPT)\<= 1.5 UNL
• Sign a formal informed consent to show that they understand that the study is in line with hospital and national policies .Estimated total survival \> 6 months.

You may not qualify if:

• Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect unreached CR after treatment
• Patients who have received neoadjuvant chemotherapy and surgery
• Patients with cognitive impairment
• Patients with any distant metastases
• Patients with any other malignancy within 5 years
• Any other disease or condition is contraindications to chemoradiotherapy (e.g., active infection, 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy, etc.); 5.Pregnant or lactating women, or fertile women who do not use contraception
• Severe bone marrow dysfunction
• Patients with bleeding tendency
• Drug abusers or alcohol addicts
• Those who are known to have a third or fourth degree allergic reaction to any treatment in the study

Sponsors & Collaborators

• Fourth Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

the Fourth Affiliated Hospital of Guangxi Medical University

Liuchow, Guangxi, 545005, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Platinum; Chemotherapy, Adjuvant

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)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Feng chengjun

  The The Fourth Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang haixin

CONTACT

13507726193; 13507726193@163.com

Feng chengjun

CONTACT

18877279562; leymj@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: February 21, 2023
• Study Start: July 1, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)