Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT04409860

The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

Led by Chongqing University Cancer Hospital · Updated on 2023-04-11

120

Participants Needed

1

Research Sites

461 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Cervical cancer stage IIb to IVa with squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma
  • Completed concurrent chemoradiation therapy with radiation dose A point 85Gy (+/-10%), B point 50Gy (+/-10%), and platinum-containing chemotherapy (cisplatin or carboplatin)
  • MRI within 4 weeks after chemoradiation shows residual lesions (non-lymph node lesion ≥10mm or lymph node shortest diameter ≥15mm)
  • ECOG performance status less than 2
  • Expected survival longer than six months
  • Hemoglobin ≥70 g/L, white blood cell count ≥3.5 x 10^9/L, absolute neutrophil count ≥1.5 x 10^9/L, platelet count ≥80 x 10^9/L
  • ALT and AST levels ≤2 times upper limit of normal, serum creatinine ≤1.5 times upper limit of normal
  • Negative serum or urine pregnancy test within 7 days before enrollment for women of childbearing age who agree to use contraception during the trial
Not Eligible

You will not qualify if you...

  • Active or uncontrolled severe infection
  • Liver cirrhosis or decompensated liver disease
  • History of immune deficiency, including HIV positive or congenital immunodeficiency
  • Unable to tolerate chemotherapy due to chronic renal insufficiency or renal failure
  • Current or past other malignant tumors
  • History of myocardial infarction, severe arrhythmia, or NYHA class 2 or higher congestive heart failure
  • Previous targeted therapy or pelvic artery embolization
  • Artery-venous thrombosis within past 6 months
  • Autoimmune diseases
  • Complications requiring drugs that may cause liver or kidney injury
  • Disease progression after chemoradiation therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Actively Recruiting

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Research Team

D

Dongling Zou, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer | DecenTrialz