Clinical trial · Interventional
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
NCT02036164CI-TRIAL-00026819ACT-LACCunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pelvic radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiation
- description
- 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
- interventionNames
- Radiation: Pelvic radiation
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Concurretn chemoradiation plus adjuvant chemotherapy
- description
- 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
- interventionNames
- Radiation: Pelvic radiation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTangjitgamol S, Tharavichitkul E, Tovanabutra C, Rongsriyam K, Asakij T, Paengchit K, Sukhaboon J, Penpattanagul S, Kridakara A, Hanprasertpong J, Chomprasert K, Wanglikitkoon S, Atjimakul T, Pariyawateekul P, Katanyoo K, Tanprasert P, Janweerachai W, Sangthawan D, Khunnarong J, Chottetanaprasith T, Supawattanabodee B, Lertsanguansinchai P, Srisomboon J, Isaranuwatchai W, Lorvidhaya V. A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial. J Gynecol Oncol. 2019 Jul;30(4):e82. doi: 10.3802/jgo.2019.30.e82. Epub 2019 Apr 10. PMID 31074236