Clinical trial NCT05863377: Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: early-stage
chemotherapy alone
poor differentiation
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with early-stage (FIGO 2018 IB1-IB2 stage) poorly differentiated cervical cancer diagnosed with radical surgery

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.


Eligibility criteria: Inclusion Criteria:

1. The age of patients is 18-70 years old.
2. Patients with cervical cancer who undergo radical hysterectomy and pelvic lymphadenectomy as initial treatment (including laparoscopic and abdominal surgery).
3. Clinical stage is IB1-IB2 according to FIGO 2018 stage.
4. The postoperative pathological type is squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma.
5. The degree of tumor differentiation is poorly differentiated.
6. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Progress Free Survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universit
state: Guangdong
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.