Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
NCT ID: NCT03534713
Last Updated: 2023-09-21
Study Results
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Basic Information
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RECRUITING
PHASE3
310 participants
INTERVENTIONAL
2020-07-17
2026-12-31
Brief Summary
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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.
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Detailed Description
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Paraaortic nodal spread in cervical cancer is a blind spot in the management of cervical cancer. It is necessary to evaluate additional treatment.
While the presence of paraaortic nodal metastases often indicates occult systemic disease, the investigators continue to treat them as a loco-regional disease.
Using neoadjuvant chemotherapy, improvement of overall survival rates is expected in women with cervical cancer and para-aortic positive lymphadenopathy without increasing the incidence of further toxicity.
The propose 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.
Secondary objectives will be to compare progression free survival, acute and long term toxicities, patterns of disease recurrence and patient quality of life between arms This is a phase III, multicenter, randomized, open label study, recruiting 310 patients during 4.5 years, with 3 years of follow up period.
Two groups will be compared : neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields, versus standard therapy alone.
Randomization will be stratified according to International federation of gynecology and obstetrics stages at diagnosis (IB1, IB2, IIA versus IIB-IVA), the size of positive para aortic lymphadenopathy and the number of node involved and will be balanced by blocks.
Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and paclitaxel followed by standard therapy with extended field external radiation therapy and concomitant chemotherapy then intracavitary brachytherapy, alone or prior to surgery, depending on response to treatment according to the current guidelines.
Women in the control arm will receive standard therapy with extended field external radiation therapy and concomitant chemotherapy then brachytherapy, alone or prior to surgery, depending on response to treatment according to the current guidelines.
Follow up will be the same between arms. But in experimental arm, during treatment phase, a clinical examination and biological assessment will be performed before each cycle of neoadjuvant chemotherapy. Therefore, at the end of neoadjuvant treatment, just before standard treatment magnetic resonance imaging and positron emission tomography-computed tomography will be performed.
Then, all Participants will be followed every 4 months until 2 years after randomization and every 6 months during the third year according to current follow-up guideline for cervical cancer. Disease response and disease progression will be assessed using clinical examination. Quality of life will be estimated at baseline, at the end of neoadjuvant chemotherapy, before intracavitary brachytherapy and at each follow-up visit until 3 years after randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neoadjuvant chemotherapy+standard therapy
neoadjuvant 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)
Carboplatin
carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
Paclitaxel
paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
Cisplatin
Cisplatin 40mg/m² given once a week during 5 weeks
Radiotherapy
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
standard therapy alone
standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
Cisplatin
Cisplatin 40mg/m² given once a week during 5 weeks
Radiotherapy
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
Interventions
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Carboplatin
carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
Paclitaxel
paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
Cisplatin
Cisplatin 40mg/m² given once a week during 5 weeks
Radiotherapy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Stéphanie MOTTON, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU de Bordeaux
Bordeaux, , France
Centre Jean Perrin
Clermont-Ferrand, , France
CHI Créteil
Créteil, , France
Institut Paoli Calmettes
Marseille, , France
CH Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
Institut de Cancérologie de l'Ouest - Nantes
Saint-Herblain, , France
CHU La Réunion
Saint-Pierre, , France
Clinique Pasteur
Toulouse, , France
University Hospital Toulouse
Toulouse, , France
CHU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Varia 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.
Chantalat 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.
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.
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.
Singh 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.
Other Identifiers
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RC31/17/0213
Identifier Type: -
Identifier Source: org_study_id
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