Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
ONCOCOL01
Phase III Study Comparing Neoadjuvant Chemotherapy With Carboplatin and Paclitaxel Followed by Standard Therapy, With Standard Therapy Alone in Women With Cervical Cancer and Para Aortic Positive Lymph Node.
1 other identifier
interventional
310
1 country
11
Brief Summary
The main objective of this study is to determine whether neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves overall survival rates compared to standard therapy alone in women with cervical cancer with paraaortic lymph node involvement. Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and paclitaxel every 21 days during 3 cycles followed by standard therapy with extended field external radiation therapy and concomitant chemotherapy. Women in the control arm will receive standard therapy with extended field external radiation therapy and concomitant chemotherapy. 310 patients will be recruited during 4.5 years, with 3 years of follow up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2020
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedStudy Start
First participant enrolled
July 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 21, 2023
September 1, 2023
6.1 years
April 16, 2018
September 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
time between random assignment and death resulting from any cause
3 years
Secondary Outcomes (4)
progression free survival
fron date of randomization until the date of first documented progression or date of death from any cause, assessed up to 3 years
adverse events
3 years
quality of life questionnaire C30 and CX24
3 years
patterns of first relapse
3 years
Study Arms (2)
Neoadjuvant chemotherapy+standard therapy
EXPERIMENTALneoadjuvant chemotherapy with carboplatin aera Under curve 5 and paclitaxel 175 mg/m² every 21 days during 3 cycles followed by standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
standard therapy alone
ACTIVE COMPARATORstandard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
Interventions
carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
Cisplatin 40mg/m² given once a week during 5 weeks
45 gray to the pelvis and para aortic area over 5 weeks + intracavitary brachytherapy alone or prior to surgery, depending on response to treatment according to the current guidelines
Eligibility Criteria
You may qualify if:
- Women with histologically proven invasive carcinoma of the uterine cervix and para aortic lymphadenopathy determined by either a positive positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography or if negative positron emission tomography computed tomography based on histological examination of paraaortic lymph node dissection.
- Performance status Eastern Cooperative Oncology Group 0-2
- Stage International Federation of Gynecology and Obstetrics IB1 to IVA at diagnosis with para-aortic lymph node involvement
- Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma
- Adequate renal function (creatinine clearance ≥60 mL/min)
- Adequate hepatic function (bilirubin \<1.5 times normal and Serum Glutamooxaloacetate Transferase \< 3 times normal)
- Adequate hematopoietic function Platelet count \> 100x10 9/l and Absolute neutrophil count \> 1.5X10 9/l)
- Written Informed consent for participation
You may not qualify if:
- Stage Federation of Gynecology and Obstetrics IVB at diagnosis
- Others histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma.
- Women who receive any prior chemotherapy for her cervical cancer
- Pregnant or lactating women
- Prior ( within the last 5 years) malignancies other than non-melanoma skin cancer
- Inadequate renal, hepatic or hematopoietic function (Cf previously)
- Cardiovascular pathology New York Heart Association II or more
- Pre-existing Peripheral neuropathy Common toxicity Criteria grade ≥ 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- Institut Claudius Regaudcollaborator
Study Sites (11)
CHU de Bordeaux
Bordeaux, 33000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
CHI Créteil
Créteil, 94000, France
Institut Paoli Calmettes
Marseille, 13009, France
CH Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers
Poitiers, 86000, France
Institut de Cancérologie de l'Ouest - Nantes
Saint-Herblain, 44805, France
CHU La Réunion
Saint-Pierre, 97448, France
Clinique Pasteur
Toulouse, 31059, France
University Hospital Toulouse
Toulouse, France
CHU de Tours
Tours, 37044, France
Related Publications (5)
Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7. doi: 10.1016/s0360-3016(01)01723-0.
PMID: 11704321BACKGROUNDVaria MA, Bundy BN, Deppe G, Mannel R, Averette HE, Rose PG, Connelly P. Cervical carcinoma metastatic to para-aortic nodes: extended field radiation therapy with concomitant 5-fluorouracil and cisplatin chemotherapy: a Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1015-23. doi: 10.1016/s0360-3016(98)00267-3.
PMID: 9869224BACKGROUNDChantalat E, Vidal F, Leguevaque P, Lepage B, Mathevet P, Deslandres M, Motton S. Cervical cancer with paraaortic involvement: do patients truly benefit from tailored chemoradiation therapy? A retrospective study on 8 French centers. Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:118-22. doi: 10.1016/j.ejogrb.2015.07.017. Epub 2015 Aug 5.
PMID: 26295788BACKGROUNDDuenas-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.
PMID: 21444871BACKGROUNDSingh RB, Chander S, Mohanti BK, Pathy S, Kumar S, Bhatla N, Thulkar S, Vishnubhatla S, Kumar L. Neoadjuvant chemotherapy with weekly paclitaxel and carboplatin followed by chemoradiation in locally advanced cervical carcinoma: a pilot study. Gynecol Oncol. 2013 Apr;129(1):124-8. doi: 10.1016/j.ygyno.2013.01.011. Epub 2013 Jan 24.
PMID: 23353129BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphanie MOTTON, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2018
First Posted
May 23, 2018
Study Start
July 17, 2020
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share