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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.