The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

  • STATUS
    Recruiting
  • End date
    Apr 5, 2028
  • participants needed
    120
  • sponsor
    Chongqing University Cancer Hospital
Updated on 19 February 2024
cancer
immunomodulator
squamous cell carcinoma
paclitaxel
adenocarcinoma
chemoradiotherapy
carcinoma
concurrent chemoradiation
adjuvant chemotherapy
adenosquamous carcinoma
cervical cancer stage
chemoradiation therapy
cervical cancer
cisplatin

Summary

The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

Description

  1. Objective:

To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.

2. Patients:

  1. Cervical cancer stage IIb to IVa with a histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
  2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)B50Gy(+/-10%)concurrent paclitaxel and cisplatin once a week for six cycles)
  3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node10mmlymph node shortest diameter15mm).
  4. Methods:

The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Details
Condition Cervical Cancer, Cervical Cancer, Uterine Cancer, Uterine Cancer
Age 18years - 75years
Treatment CCRT, Paclitaxel, Cisplatin
Clinical Study IdentifierNCT04409860
SponsorChongqing University Cancer Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Cervical cancer stage IIb to IVa with a histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
Complete CCRT(Radiation Does: A point 85Gy(+/-10%)B50Gy(+/-10%)concurrent paclitaxel and cisplatin once a week for six cycles)
MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node10mmlymph node shortest diameter15mm)
ECOG2
Expected survival is longer than six months
Hb70g/LWBC3.5109/ L ANC1.5109/LPLT80109/L
ALT and AST2ULN, Serum creatinine1.5ULN
The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial

Exclusion Criteria

Activity or uncontrol severe infection
Liver cirrhosis, Decompensated liver disease
History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
Have suffered or combined with other malignant tumor
Myocardial infarction, severe arrhythmia and NYHA (New York heart association)2 for congestive heart failure
A history targeted therapy or pelvic artery embolization
Artery-enous thrombosis within 6 months
Patients with autoimmune diseases
Complications, need to be treatment with drugs which may lead to liver or kidney injury
Patients with disease progression after chemoradiation
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