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

NCT05863377 | Unknown

• 1 other identifier: SYSEC-KY-KS-2021-197
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival (PFS)

  The time between surgery and clinical recurrence.

  5 years

Secondary Outcomes (1)

• Overall Survival (OS)

  5 years

Study Arms (2)

Adjuvant Chemotherapy Group

The patients of this group receive adjuvant chemotherapy after surgery.

No-Further Treatment Group

The patients of this group only receive regular follow-up without adjuvant therapy.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 31401822 BACKGROUND

• 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.

  PMID: 16427212 BACKGROUND

• 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.

  PMID: 17502627 BACKGROUND

• 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.

  PMID: 24357798 BACKGROUND

• 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.

  PMID: 30207099 BACKGROUND

• 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.

  PMID: 22592722 BACKGROUND

• 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.

  PMID: 22357252 BACKGROUND

• 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.

  PMID: 8626113 BACKGROUND

• 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.

  PMID: 20421158 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

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

Central Study Contacts

Huaiwu Lu, Study Director

CONTACT

+86 18688395806; luhuaiwu@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 18, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-01

Locations

CN (1)