NCT04733820RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 2 Feb 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 21 Jan 2021
- Start date
- 1 Feb 2021
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Huazhong University of Science and Technology
- Diseases
- Cervical cancer
- NCT number
- NCT04733820
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 340
- From 1 Feb 2021 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Drug and/or alcohol abuse.
Other illness
- 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.
- Severe diseases of other important systems and organs.
Other
- Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
- Participate in other clinical trials.
- Persons without disposing capacity.
- Unable or unwilling to sign informed consents.
- Not eligible for the study judged by researchers.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.