Clinical trial · Interventional
The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
NCT04409860CI-TRIAL-00065514CQGOG0102recruitingN/AClinicalTrials.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)
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
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCRT | Radiation | — | UNRESOLVED |
| Paclitaxel, Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- In this group, observation is given after CCRT.
- interventionNames
- Radiation: CCRT
- type
- EXPERIMENTAL
- label
- trial group
- description
- In this group, adjuvant chemotherapy is given after CCRT.
- interventionNames
- Radiation: CCRT
- Drug: Paclitaxel, Cisplatin
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%),B点50Gy(+/-10%),concurrent platinum-containing chemotherapy (cisplatin or carboplatin)) 3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 4. ECOG\<2 5. Expected survival is longer than six months 6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L 7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN 8. 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: 1. Activity or uncontrol severe infection 2. Liver cirrhosis, Decompensated liver disease 3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease 4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure 5. Have suffered or combined with other malignant tumor 6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure 7. A history targeted therapy or pelvic artery embolization 8. Artery-enous thrombosis within 6 months 9. Patients with autoimmune diseases 10. Complications, need to be treatment with drugs which may lead to liver or kidney injury 11. Patients with disease progression after chemoradiation
References
Publications (19)
- BACKGROUNDde Sanjose S, Serrano B, Castellsague X, Brotons M, Munoz J, Bruni L, Bosch FX. Human papillomavirus (HPV) and related cancers in the Global Alliance for Vaccines and Immunization (GAVI) countries. A WHO/ICO HPV Information Centre Report. Vaccine. 2012 Nov 20;30 Suppl 4:D1-83, vi. doi: 10.1016/S0264-410X(12)01435-1. No abstract available. PMID 23510764
- BACKGROUNDVerma J, Monk BJ, Wolfson AH. New Strategies for Multimodality Therapy in Treating Locally Advanced Cervix Cancer. Semin Radiat Oncol. 2016 Oct;26(4):344-8. doi: 10.1016/j.semradonc.2016.05.003. Epub 2016 May 26. PMID 27619255
- BACKGROUNDRose PG. Chemoradiotherapy for cervical cancer. Eur J Cancer. 2002 Jan;38(2):270-8. doi: 10.1016/s0959-8049(01)00352-5. PMID 11803143
- BACKGROUNDChemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10. PMID 19001332
- BACKGROUNDChereau E, DE LA Hosseraye C, Ballester M, Monnier L, Rouzier R, Touboul E, Darai E. The role of completion surgery after concurrent radiochemotherapy in locally advanced stages IB2-IIB cervical cancer. Anticancer Res. 2013 Apr;33(4):1661-6. PMID 23564812
- BACKGROUNDCarcopino X, Houvenaeghel G, Buttarelli M, Esterni B, Tallet A, Goncalves A, Jacquemier J. Equivalent survival in patients with advanced stage IB-II and III-IVA cervical cancer treated by adjuvant surgery following chemoradiotherapy. Eur J Surg Oncol. 2008 May;34(5):569-75. doi: 10.1016/j.ejso.2007.04.006. Epub 2007 May 25. PMID 17531428
- BACKGROUNDHequet D, Marchand E, Place V, Fourchotte V, De La Rochefordiere A, Dridi S, Coutant C, Lecuru F, Bats AS, Koskas M, Bretel JJ, Bricou A, Delpech Y, Barranger E. Evaluation and impact of residual disease in locally advanced cervical cancer after concurrent chemoradiation therapy: results of a multicenter study. Eur J Surg Oncol. 2013 Dec;39(12):1428-34. doi: 10.1016/j.ejso.2013.10.006. Epub 2013 Oct 23.