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

NCT03308591 | Completed Phase 3 DMC

• 1 other identifier: CSEM GOG-005B
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Cervical Neoplasm; Cervical Cancer; Uterine Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS) of the neoadjuvant chemotherapy Group

  DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.

  Up to 3-year

Secondary Outcomes (1)

• DSF of the synchro-chemoradiotheraphy group

  Up to 3-year

Other Outcomes (1)

• chemotherapy- and radiotherapy- related adverse effects respectively in two groups

  Up to 3-year

Study Arms (2)

NACT

EXPERIMENTAL

The patients will receive 2 courses of platinum based chemotherapy before surgery, 2-3 weeks after each course, doctors will appraise the effect of the chemotherapy. Patients who are sensitive to the treatment will undergo radical hysterectomy and pelvic lymph node dissection 3 weeks after chemotherapy. And 2-3weeks after the surgery, patients will receive adjuvant chemotherapy according to the pathological risk factors.

Drug: NACT; Procedure: RT+PLND; Drug: Adjuvant chemotherapy

PST

ACTIVE COMPARATOR

The patients in this group will undergo radical hysterectomy and pelvic lymph node dissection directly, and 2-6 weeks after the surgery, they will receive adjuvant chemotherapy according to the pathological risk factors.

Procedure: RT+PLND; Drug: Adjuvant chemotherapy

Interventions

NACT DRUG

Platin based chemotherapy

NACT

RT+PLND PROCEDURE

radical hysterectomy+pelvic lymphadenectomy

NACT; PST

Adjuvant chemotherapy DRUG

Platin based chemotherapy

NACT; PST

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis IB2 or IIA2 stage cervical cancer;
• age less than or equal to 65 years old;
• laboratory examination results: WBC ≥ 4\*10\^9/L, NEU ≥ 20\*10\^9/L, PLT ≥ 80\*10\^9/L, serum bilirubin ≤ 2 multiples of the upper normal limit, aminopherase ≤ 2 multiples of the upper normal limit. BUN ≤ normal limit, CR ≤ normal limit;
• KARNOFSKY score ≥ 60;
• No prior treatment;
• pathological diagnosis before surgery is invasive squamous cell carcinoma of cervix;
• well-compliance and willing to keep in touch;
• willing to participate in this study, and sign the informed consent;

You may not qualify if:

• participate in other drug clinical trials at the same time;
• respiratory depression, airway obstruction and hypoxia;
• heart diseases (cardiac function at grade II, III or above);
• hematological diseases;
• obvious dysfunction of liver and kidney (above 3 multiples of the upper normal limit);
• a history of brain dysfunction;
• unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
• drug abuse or a history of drug abuse;
• unable or unwilling to sign informed consents;
• unable or unwilling to follow the protocols;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Hu Y, Han Y, Shen Y, Chen J, Chen Y, Chen Y, Tang J, Xue M, Hong L, Cheng W, Wang D, Liang Z, Wang Y, Zhang Q, Xing H, Zhang Y, Yi C, Yu Z, Chen Y, Cui M, Ma C, Yang H, Li R, Long P, Zhao Y, Qu P, Tao G, Yang L, Wu S, Liu Z, Yang P, Lv W, Xie X, Ma D, Wang H, Li K. Neoadjuvant chemotherapy for patients with international federation of gynecology and obstetrics stages IB3 and IIA2 cervical cancer: a multicenter prospective trial. BMC Cancer. 2022 Dec 5;22(1):1270. doi: 10.1186/s12885-022-10355-3.

  PMID: 36471257 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

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)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Ding Ma, MD PhD

  Huazhong University of Science and Technology

  STUDY CHAIR

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: chief physician

Study Record Dates

• First Submitted: October 8, 2017
• First Posted: October 12, 2017
• Study Start: January 11, 2016
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

CN (1)