A Phase 3 interventional study of Carboplatin and Paclitaxel in Cervical Cancer TNM Staging Regional Lymph Nodes (N), sponsored by University Hospital, Toulouse. Recruiting at 11 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by University Hospital, Toulouse · Phase 3, Interventional, and Treatment
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.
The survival outcome of patients with carcinoma of the cervix and positive paraaortic lymph node is poor and the potential benefit of neoadjuvant chemotherapy before extended field chemoradiotherapy has never been assessed.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 310 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
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)
Drug: Carboplatin · Drug: Paclitaxel · Drug: Cisplatin · Radiation: Radiotherapy
standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
Drug: Cisplatin · Radiation: Radiotherapy
carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
Also known as: Carbo
paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
Also known as: Taxol
Cisplatin 40mg/m² given once a week during 5 weeks
Also known as: Platinol
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
Also known as: radiation therapy
Overall survival
time between random assignment and death resulting from any cause
Time frame: 3 years
progression free survival
time from randomization to first documentation of disease progression or death due to any cause.
Time frame: 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
classified using the Common Terminology Criteria for Adverse Events and coded using Medical Dictionary for Regulatory Activities dictionary Pattern of disease recurrence will include locoregional recurrence and distant metastasis
Time frame: 3 years
quality of life questionnaire C30 and CX24
assessed using the European Organization for Research and Treatment Quality of Life Questionnaire C30 and CX24, all subscales responses will be converted to 0 to 100 scales according to European Organization for Research and Treatment guidelines
Time frame: 3 years
patterns of first relapse
location of relapse or metastasis by magnetic resonance imaging
Time frame: 3 years
Plan to share: No
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University Hospital, Toulouse