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The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorChongqing University Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma

Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))

MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).

ECOG<2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CCRT

    Radiation

    Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)

  • Paclitaxel, Cisplatin

    Drug

    The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: trial groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival

Time frame
2 years

Secondary outcomes

1

OS

5 years overall survival

Time frame
5 years
2

ORR

To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing University Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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