Study of Neoadjuvant Chemotherapy Versus Definite Concurrent Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer

NCT05189028 | Recruiting Phase 3

• 1 other identifier: NACT-CC-001
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III randomized prospective clinical study was conducted to compare the short-term and long-term outcomes of gemcitabine and cisplatin neoadjuvant chemotherapy versus definite cisplatin weekly concurrent chemoradiotherapy in patients with locally advanced bulk cervical cancer.

Conditions

Cervical Cancer; Neoadjuvant Chemotherapy

Keywords

Cervical Cancer; NACT(Neoadjuvant Chemotherapy); Locally Advanced Bulk Cervical Cancer; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 years

Secondary Outcomes (4)

• Local-regional control

  2 years

• Distant metastasis-free survival

  2 years

• Disease-free survival

  2 years after randomization

• Acute and late toxicities using CTCAE v4.0

  2 years

Study Arms (2)

Locally advanced bulk cervical cancer neoadjuvant chemotherapy group(NACT)

EXPERIMENTAL

Radiation: Radiotherapy with IMRT/VMAT+192Ir-HDR brachytherapy Radiotherapy: 46Gy/23F to external pelvic radiotherapy and 14Gy/7F boost to imaging diagnosis of positive lymph nodes 192Ir-HDR brachytherapy:A Point dose 6Gy\*4-6F Drug: gemcitabine plus cisplatin,cisplatin Neoadjuvant chemotherapy:gemcitabine and cisplatin (GP) regimen\*2 cycles Concurrent Chemotherapy: Weekly cisplatin chemotherapy ≥5 cycles

Drug: gemcitabine and cisplatin

Locally advanced bulk cervical cancer chemoradiotherapy group(CCRT)

ACTIVE COMPARATOR

Radiation: Radiotherapy with IMRT/VMAT+192Ir-HDR brachytherapy Radiotherapy: 46Gy/23F to external pelvic radiotherapy and 14Gy/7F boost to imaging diagnosis of positive lymph nodes 192Ir-HDR brachytherapy:APoint A dose 6Gy\*4-6F Drug: cisplatin Concurrent Chemotherapy: Weekly cisplatin chemotherapy ≥5 cycles

Drug: gemcitabine and cisplatin

Interventions

gemcitabine and cisplatin DRUG

Neoadjuvant chemotherapy:gemcitabine and cisplatin

Locally advanced bulk cervical cancer chemoradiotherapy group(CCRT); Locally advanced bulk cervical cancer neoadjuvant chemotherapy group(NACT)

Eligibility Criteria

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

You may qualify if:

• Histologic proof of primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma.
• According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed with local tumor ≥4cm in stage IB3, IIA2, IIB-IVA by at least one expert with associate high degree or above in the department of gynecology and gynecology.
• Age≥18 \& ≤70.
• ECOG score 0-2.
• WBC ≥4.0×109/L, hemoglobin ≥60g/L, platelet ≥100.0×109/L; Serum bilirubin ≤ upper limit of normal, ALT, AST, ALP ≤ upper limit of normal ×2.5; Urea nitrogen (BUN) ≤ upper limit of normal ×1.5, creatinine (Cr)≤ upper limit of normal ×1.5.
• Patients with prior malignancy are eligible if disease-free ≥ 5 years.
• Signed study-specific informed consent form prior to study entry.

You may not qualify if:

• Line has anti-tumor treatment, including chemotherapy, radiotherapy, surgery).
• Stage Ia1- IB2 and IVB cervical cancer.
• Patients with uncontrolled serious medical or mental illnesses.
• Women in pregnancy or lactation.
• Psychological, family, social factors, such as lead to no informed consent.
• Into the group of the first five years in addition to the cervical cancer merger other patients with a history of malignant tumor.

Sponsors & Collaborators

• Chuangzhen Chen: lead

Study Sites (1)

Cancer Hospital, Shantou University Medical College

Shantou, Guangdong, 515031, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Gemcitabine; Cisplatin

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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Chuangzhen Chen, MD

  Cancer Hospital, Shantou University Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhou Zhan, MD

CONTACT

86-13929699280; 6780540@qq.com

Chuangzhen Chen, MD

CONTACT

86-13923995569; stccz@139.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: July 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

CN (1)