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RecruitingNCT04409860CQGOG0102Updated Apr 11, 2023

The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

An interventional study of CCRT and Paclitaxel, Cisplatin in Cervical Cancer, sponsored by Chongqing University Cancer Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Chongqing University Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started May 2020; still recruiting 6 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

Read the detailed 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 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).
  3. 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.

02

Conditions studied

  • Cervical Cancer

Keywords

  • Locally adcanced
  • CCRT
  • Adjuvant chemotherapy
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Chongqing University Cancer Hospital is the lead sponsor of 40 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    control group

    In this group, observation is given after CCRT.

    Radiation: CCRT

  • Experimental
    trial group

    In this group, adjuvant chemotherapy is given after CCRT.

    Radiation: CCRT · Drug: Paclitaxel, Cisplatin

Interventions

  • RadiationCCRT

    Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)

    Also known as: control group: CCRT + observation

  • DrugPaclitaxel, Cisplatin

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

    Also known as: trial group: CCRT + adjuvant chemotherapy

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Chongqing Cancer Hospital
    Chongqing, Chongqing 400030, China
    • Dongling Zou, M.D. · Contact · cqzl_zdl@163.com · 13657690699
    • Dongling Zou, M.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • de 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. PubMed 23510764 ↗
  • Verma 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. PubMed 27619255 ↗
  • Rose PG. Chemoradiotherapy for cervical cancer. Eur J Cancer. 2002 Jan;38(2):270-8. doi: 10.1016/s0959-8049(01)00352-5. PubMed 11803143 ↗
  • Chemoradiotherapy 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. PubMed 19001332 ↗
  • Chereau 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. PubMed 23564812 ↗
  • Carcopino 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. PubMed 17531428 ↗
  • Hequet 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. PubMed 24183796 ↗
  • Ferrandina G, Margariti PA, Smaniotto D, Petrillo M, Salerno MG, Fagotti A, Macchia G, Morganti AG, Cellini N, Scambia G. Long-term analysis of clinical outcome and complications in locally advanced cervical cancer patients administered concomitant chemoradiation followed by radical surgery. Gynecol Oncol. 2010 Dec;119(3):404-10. doi: 10.1016/j.ygyno.2010.08.004. PubMed 20817228 ↗
  • Colombo PE, Bertrand MM, Gutowski M, Mourregot A, Fabbro M, Saint-Aubert B, Quenet F, Gourgou S, Kerr C, Rouanet P. Total laparoscopic radical hysterectomy for locally advanced cervical carcinoma (stages IIB, IIA and bulky stages IB) after concurrent chemoradiation therapy: surgical morbidity and oncological results. Gynecol Oncol. 2009 Sep;114(3):404-9. doi: 10.1016/j.ygyno.2009.05.043. Epub 2009 Jun 24. PubMed 19555996 ↗
  • Houvenaeghel G, Lelievre L, Rigouard AL, Buttarelli M, Jacquemier J, Viens P, Gonzague-Casabianca L. Residual pelvic lymph node involvement after concomitant chemoradiation for locally advanced cervical cancer. Gynecol Oncol. 2006 Jul;102(1):74-9. doi: 10.1016/j.ygyno.2005.11.037. Epub 2006 Jan 10. PubMed 16406062 ↗
  • Houvenaeghel G, Lelievre L, Buttarelli M, Jacquemier J, Carcopino X, Viens P, Gonzague-Casabianca L. Contribution of surgery in patients with bulky residual disease after chemoradiation for advanced cervical carcinoma. Eur J Surg Oncol. 2007 May;33(4):498-503. doi: 10.1016/j.ejso.2006.10.011. Epub 2006 Dec 6. PubMed 17156969 ↗
  • Vrdoljak E, Omrcen T, Novakovic ZS, Jelavic TB, Prskalo T, Hrepic D, Hamm W. Concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy for women with locally advanced carcinoma of the uterine cervix--final results of a prospective phase II-study. Gynecol Oncol. 2006 Nov;103(2):494-9. doi: 10.1016/j.ygyno.2006.03.060. Epub 2006 Jun 30. PubMed 16814371 ↗
  • Domingo E, Lorvidhaya V, de Los Reyes R, Syortin T, Kamnerdsupaphon P, Lertbutsayanukul C, Vito-Cruz E, Tharavichitkul E, Jin K, Yoshihara M, Cupino N, Lertsanguansinchai P. Capecitabine-based chemoradiotherapy with adjuvant capecitabine for locally advanced squamous carcinoma of the uterine cervix: phase II results. Oncologist. 2009 Aug;14(8):828-34. doi: 10.1634/theoncologist.2009-0041. Epub 2009 Aug 6. PubMed 19661184 ↗
  • Choi CH, Lee YY, Kim MK, Kim TJ, Lee JW, Nam HR, Huh SJ, Lee JH, Bae DS, Kim BG. A matched-case comparison to explore the role of consolidation chemotherapy after concurrent chemoradiation in cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1252-7. doi: 10.1016/j.ijrobp.2010.07.2006. Epub 2010 Nov 13. PubMed 21075554 ↗
  • Zhang MQ, Liu SP, Wang XE. Concurrent chemoradiotherapy with paclitaxel and nedaplatin followed by consolidation chemotherapy in locally advanced squamous cell carcinoma of the uterine cervix: preliminary results of a phase II study. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):821-7. doi: 10.1016/j.ijrobp.2009.08.069. Epub 2010 Mar 6. PubMed 20207507 ↗
  • Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28. PubMed 21444871 ↗
  • Tang J, Tang Y, Yang J, Huang S. Chemoradiation and adjuvant chemotherapy in advanced cervical adenocarcinoma. Gynecol Oncol. 2012 May;125(2):297-302. doi: 10.1016/j.ygyno.2012.01.033. Epub 2012 Jan 31. PubMed 22307061 ↗
  • Lorvidhaya V, Chitapanarux I, Sangruchi S, Lertsanguansinchai P, Kongthanarat Y, Tangkaratt S, Visetsiri E. Concurrent mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally advanced carcinoma of the cervix: a randomized trial. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1226-32. doi: 10.1016/s0360-3016(02)04405-x. PubMed 12654431 ↗
  • Tangjitgamol 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. PubMed 31074236 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04409860
Lead sponsor
Chongqing University Cancer Hospital
Responsible party
Dongling Zou (Associated Director, Chongqing University Cancer Hospital) — Principal investigator
First posted
Jun 1, 2020
Start date
May 26, 2020
Primary completion
Apr 2024 (estimated)
Completion
Apr 2029 (estimated)
Last update
Apr 11, 2023

Study contacts

Dongling Zou, M.D.
Contact
cqzl_zdl@163.com
13657690699
Dongling Zou, M.D.
principal investigator · Chongqing University Cancer Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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