AzTrials
AzTrials

Cervical CancerNCT05863377

Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer

An observational study of Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is aimed to enroll patients with early-stage cervical cancer (FIGO 2018 IB1-IB2) who undergo radical hysterectomy and the postoperative pathology doesn't meet Sedlis criteria or the "four-factor" model but with poorly differentiated squamous/adenocarcinoma/adenosquamous carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer
How many people
450 participants
Where
1 siteChina
Study dates
1 Jan 2022to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with early-stage (FIGO 2018 IB1-IB2 stage) poorly differentiated cervical cancer diagnosed with radical surgery

Who may be able to join

  • The age of patients is 18-70 years old.
  • Patients with cervical cancer who undergo radical hysterectomy and pelvic lymphadenectomy as initial treatment (including laparoscopic and abdominal surgery).
  • Clinical stage is IB1-IB2 according to FIGO 2018 stage.
  • The postoperative pathological type is squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma.
  • The degree of tumor differentiation is poorly differentiated.
  • Do not meet the Sedlis criteria or the four-factor model, but meet one of the following factors: ① LVSI (+); ② tumor diameter > 2cm; ③ Depth of cervical stromal invasion > superficial 1/3; (4) adenocarcinoma.

Who cannot join

  • Postoperative pathological stage ≥IIA (according to the 2018 FIGO staging system).
  • Patients with the following high risk factors: ① lymph node metastasis; ② parametrial involvement; ③ positive surgical margin; ④ vaginal involvement.
  • Patients received neoadjuvant chemotherapy.
  • There was evidence of distant metastasis on preoperative imaging examination.
  • Patients received postoperative radiotherapy.
  • History of abdominal or pelvic radiotherapy.
  • Patients with other malignant tumors.
  • Patients with missing or partially missing clinical, surgical, and pathological data were lost to follow-up.

Trial locations and contacts

1 site in 1 country.

Huaiwu Lu, Study Director contact

+86 18688395806

luhuaiwu@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universit

    Guangzhou, Guangdong

    Huaiwu Lu, associated professor, +8618688395806, luhuaiwu@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer But Without the Criteria for Adjuvant Radiotherapy According to NCCN Guidelines

This study is aimed to enroll patients with early-stage cervical cancer (FIGO 2018 IB1-IB2) who undergo radical hysterectomy and the postoperative pathology doesn't meet Sedlis criteria or the "four-factor" model but with poorly differentiated squamous/adenocarcinoma/adenosquamous carcinoma. Patients will be randomly divided into two groups in a 1:1 ratio. The experimental group received 4 courses of paclitaxel and cisplatin (once every 3 weeks) for adjuvant chemotherapy within 4 weeks after surgery, while the control group don't not receive any adjuvant therapy but only received regular follow-up. The disease status of all patients will be evaluated within 4 weeks after the end of all treatment and every 12 weeks thereafter, including gynecological examination, laboratory indicators, imaging evaluation, and the prognosis of the two groups will be compared.

Conditions
Cervical Cancer
Keywords
early-stage, chemotherapy alone, poor differentiation
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05863377
Study groupRoleWhat they receive
Adjuvant Chemotherapy GroupThe patients of this group receive adjuvant chemotherapy after surgery.
No-Further Treatment GroupThe patients of this group only receive regular follow-up without adjuvant therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progress Free Survival (PFS)

    The time between surgery and clinical recurrence.

    Measured: 5 years

Secondary outcomes (1)

  1. Overall Survival (OS)

    The time interval between the cancer diagnosis and the death of any reason.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05863377
Sponsor's protocol ID
SYSEC-KY-KS-2021-197
Status last verified
Jan 2023
First submitted
28 Apr 2023
Last updated
18 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Paik ES, Lim MC, Kim MH, Kim YH, Song ES, Seong SJ, Suh DH, Lee JM, Lee C, Choi CH. Prognostic Model for Survival and Recurrence in Patients with Early-Stage Cervical Cancer: A Korean Gynecologic Oncology Group Study (KGOG 1028). Cancer Res Treat. 2020 Jan;52(1):320-333. doi: 10.4143/crt.2019.124. Epub 2019 Aug 5.

    PubMed 31401822

  • Rotman M, Sedlis A, Piedmonte MR, Bundy B, Lentz SS, Muderspach LI, Zaino RJ. A phase III randomized trial of postoperative pelvic irradiation in Stage IB cervical carcinoma with poor prognostic features: follow-up of a gynecologic oncology group study. Int J Radiat Oncol Biol Phys. 2006 May 1;65(1):169-76. doi: 10.1016/j.ijrobp.2005.10.019. Epub 2006 Jan 19.

    PubMed 16427212

  • Rose PG, Ali S, Watkins E, Thigpen JT, Deppe G, Clarke-Pearson DL, Insalaco S; Gynecologic Oncology Group. Long-term follow-up of a randomized trial comparing concurrent single agent cisplatin, cisplatin-based combination chemotherapy, or hydroxyurea during pelvic irradiation for locally advanced cervical cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Jul 1;25(19):2804-10. doi: 10.1200/JCO.2006.09.4532. Epub 2007 May 14.

    PubMed 17502627

  • Ryu SY, Kim MH, Nam BH, Lee TS, Song ES, Park CY, Kim JW, Kim YB, Ryu HS, Park SY, Kim KT, Cho CH, Lee C, Kim SM, Kim BG, Bae DS, Kim YT, Nam JH. Intermediate-risk grouping of cervical cancer patients treated with radical hysterectomy: a Korean Gynecologic Oncology Group study. Br J Cancer. 2014 Jan 21;110(2):278-85. doi: 10.1038/bjc.2013.716. Epub 2013 Dec 19.

    PubMed 24357798

  • Matsuo K, Mandelbaum RS, Machida H, Purushotham S, Grubbs BH, Roman LD, Wright JD. Association of tumor differentiation grade and survival of women with squamous cell carcinoma of the uterine cervix. J Gynecol Oncol. 2018 Nov;29(6):e91. doi: 10.3802/jgo.2018.29.e91.

    PubMed 30207099

  • Rogers L, Siu SS, Luesley D, Bryant A, Dickinson HO. Radiotherapy and chemoradiation after surgery for early cervical cancer. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD007583. doi: 10.1002/14651858.CD007583.pub3.

    PubMed 22592722

  • Sehouli J, Runnebaum IB, Fotopoulou C, Blohmer U, Belau A, Leber H, Hanker LC, Hartmann W, Richter R, Keyver-Paik MD, Oberhoff C, Heinrich G, du Bois A, Olbrich C, Simon E, Friese K, Kimmig R, Boehmer D, Lichtenegger W, Kuemmel S. A randomized phase III adjuvant study in high-risk cervical cancer: simultaneous radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R): a NOGGO-AGO Intergroup Study. Ann Oncol. 2012 Sep;23(9):2259-2264. doi: 10.1093/annonc/mdr628. Epub 2012 Feb 21.

    PubMed 22357252

  • Curtin JP, Hoskins WJ, Venkatraman ES, Almadrones L, Podratz KC, Long H, Teneriello M, Averette HA, Sevin BU. Adjuvant chemotherapy versus chemotherapy plus pelvic irradiation for high-risk cervical cancer patients after radical hysterectomy and pelvic lymphadenectomy (RH-PLND): a randomized phase III trial. Gynecol Oncol. 1996 Apr;61(1):3-10. doi: 10.1006/gyno.1996.0087.

    PubMed 8626113

  • Ryu SY, Park SI, Nam BH, Cho CK, Kim K, Kim BJ, Kim MH, Choi SC, Lee ED, Lee KH. Is adjuvant chemoradiotherapy overtreatment in cervical cancer patients with intermediate risk factors? Int J Radiat Oncol Biol Phys. 2011 Mar 1;79(3):794-9. doi: 10.1016/j.ijrobp.2009.11.019. Epub 2010 Apr 24.

    PubMed 20421158

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huaiwu Lu, Study Director (+86 18688395806, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress Free Survival (PFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05863377, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in