Trial | NCT02036164  Report issue

Title

Adjuvant Chemotherapy for Locally Advanced Cervical Cancer
Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    500
Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.
Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.

This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.
Study Started
Jan 31
2014
Primary Completion
Jan 31
2018
Anticipated
Study Completion
Jan 31
2019
Anticipated
Last Update
Apr 06
2017

Radiation Pelvic radiation

Radiation: Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks Brachytherapy 30-35 Gy for 4-5 times

  • Other names: External beam pelvic radiation therapy and brachytherapy

Drug Cisplatin

Cisplatin 40 mg/m2 i.v.

  • Other names: - Kemoplat®, - Platin®, Drugs:, - Cisplatin

Drug Paclitaxel

Paclitaxel 175 mg m2 i.v.

  • Other names: - Intaxel®, - Anzatax®

Drug Carboplatin

Carboplatin AUC 5 i.v.

  • Other names: - Carboplatin®, - Kemocarb®

Concurrent chemoradiation Active Comparator

Radiation: Radiation Therapy External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin - Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy

Concurretn chemoradiation plus adjuvant chemotherapy Experimental

Radiation: Radiation Therapy External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin, paclitaxel, carboplatin Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel

Criteria 

Inclusion Criteria:

Age 18-70 years
Cervical cancer FIGO stage IIB-IVA
Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
ECOG performance status 0-2
No history of other cancer except basal cell carcinoma
Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)
Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl
Consent to participate

Exclusion Criteria:

Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI
Adnexal mass from physical examination or imaging study
Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
Pregnancy or lactation
No Results Posted