Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery

NCT04733820 | Recruiting Phase 3 DMC

• 1 other identifier: 2020-S111
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.

Conditions

Uterine Cervical Neoplasms; Cervical Cancer

Keywords

Cervical Cancer; NACT; Adjuvant Chemotherapy; Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.

  5 year

Secondary Outcomes (4)

• Overall survival （OS）

  5 year

• Quality of Life Outcomes

  5 years

• Quality of Life Outcomes of cervical cancer

  5 years

• Incidence of Toxicity

  5 years

Study Arms (2)

Adjuvant chemotherapy group

EXPERIMENTAL

Participant will receive at least 2 cycles of adjuvant chemotherapy. If having any of the following factors, participant will receive additional 2 cycles of adjuvant chemotherapy per risk factor. All patients received maximum 6 cycles of postoperative chemotherapy. Risk factors: (1) Deep cervical invasion（≥ 2/3）；（2）Differentiation grade 2-3；（3）Lymphatic vascular space infiltration；（4）Adenocarcinoma or adenosquamous carcinoma；（5）Tumor size ≥ 4cm before surgery.

Drug: Adjuvant chemotherapy

Control group

NO INTERVENTION

The participants receive no intervention.

Interventions

Adjuvant chemotherapy DRUG

Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.

Adjuvant chemotherapy group

Eligibility Criteria

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

You may qualify if:

• Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter \> 4cm before treatment.
• Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
• Age：18-70 years old.
• ECOG status score ≤1;
• WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
• Well-compliance and willing to keep in touch.
• Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.

You may not qualify if:

• After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
• Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
• Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
• Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
• Participate in other clinical trials.
• Severe diseases of other important systems and organs.
• Persons without disposing capacity.
• Drug and/or alcohol abuse.
• Unable or unwilling to sign informed consents.
• Not eligible for the study judged by researchers.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Hunan Cancer Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

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

Central Study Contacts

Ding Ma, M.D., PhD

CONTACT

0086-27-83662681; dma@tjh.tjmu.edu.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: Tongji Hospital, Tongji Medical College

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 2, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

CN (1)