Cervical Cancer TNM Staging Regional Lymph Nodes (N)Phase 3ONCOCOL01NCT03534713
Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
A Phase 3 study testing Carboplatin, Paclitaxel and Cisplatin in people with Cervical Cancer TNM Staging Regional Lymph Nodes (N), run by University Hospital, Toulouse at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer TNM Staging Regional Lymph Nodes (N)
- What is being tested?
- Carboplatin, Paclitaxel and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 11 sitesFrance
- Study dates
- 17 Jul 2020to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Nicolas GIRAUD, MD, 0557623300 ext. 33, nicolas.giraud@chu-bordeaux.fr
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Laure VACHER, MD, 0473278080 ext. 33, laure.vacher@clermont.unicancer.fr
- Recruiting
CHI Créteil
Créteil, 94000
Zineb SELLAM, MD, 0157023021 ext. 33, zineb.sellam@chicreteil.fr
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
Renaud SABATIER, MD, 0491223789 ext. 33, sabatierr@ipc.unicancer.fr
- Recruiting
CH Lyon Sud
Pierre-Bénite, 69495
Pierre DESCARGUES, MD, 0478862085, pierre.descargues@chu-lyon.fr
- Recruiting
CHU de Poitiers
Poitiers, 86000
Patrick BOUCHAERT, MD, 0549444549 ext. 33, patrick.bouchaert@chu-poitiers.fr
- Recruiting
Institut de Cancérologie de l'Ouest - Nantes
Saint-Herblain, 44805
Dominique BERTON, MD, 0240679705 ext. 33, dominique.berton@ico.unicancer.fr
- Recruiting
CHU La Réunion
Saint-Pierre, 97448
Malik BOUKERROU, MD, 262262359000, malik.boukerrou@chu-reunion.fr
- Recruiting
Clinique Pasteur
Toulouse, 31059
Ludivine GENRE, MD, 0562213630 ext. 33, lgenre@clinique-pasteur.fr
- Recruiting
University Hospital Toulouse
Toulouse
Stéphanie MOTTON, MD, motton.s@chu-toulouse.fr
- Recruiting
CHU de Tours
Tours, 37044
Lobna OULDAMER, MD, 0247476075 ext. 33, l.ouldamer@chu-tours.fr
About this study
Official title: 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.
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.
Read the detailed description
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.
- Being tested
- Carboplatin, Paclitaxel, Cisplatin, Radiotherapy
- Keywords
- Neoadjuvant chemotherapy, Cervical Cancer, Paraaortic Lymph Node Involvement, Carboplatin, Paclitaxel
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Carbo
carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
PaclitaxelDrug
Also called Taxol
paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
CisplatinDrug
Also called Platinol
Cisplatin 40mg/m² given once a week during 5 weeks
RadiotherapyRadiation
Also called radiation therapy
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
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy+standard therapy | Experimental | 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) Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy |
| standard therapy alone | Active comparator | standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly) Receives: Drug: Cisplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
time between random assignment and death resulting from any cause
Measured: 3 years
Secondary outcomes (4)
progression free survival
time from randomization to first documentation of disease progression or death due to any cause.
Measured: 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
Measured: 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
Measured: 3 years
patterns of first relapse
location of relapse or metastasis by magnetic resonance imaging
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start17 Jul 2020
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer TNM Staging Regional Lymph Nodes (N)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Claudius Regaud
- Responsible party
- Sponsor
- Investigators
- Stéphanie MOTTON, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534713
- Sponsor's protocol ID
- RC31/17/0213
- Acronym
- ONCOCOL01
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11704321Varia 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.
PubMed 9869224Chantalat 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.
PubMed 26295788Duenas-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 21444871Singh 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.
PubMed 23353129
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03534713
- Acronym / sponsor ID
- ONCOCOL01 / RC31/17/0213
- Keywords
- Neoadjuvant chemotherapy, Cervical Cancer, Paraaortic Lymph Node Involvement, Carboplatin, Paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut Claudius Regaud
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy+standard therapy | Experimental | Drug: Carboplatin, Drug: Paclitaxel, Drug: Cisplatin, Radiation: Radiotherapyneoadjuvant 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 comparator | Drug: Cisplatin, Radiation: Radiotherapystandard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: Carbocarboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles | Drug | Neoadjuvant chemotherapy+standard therapy |
| PaclitaxelAlso: Taxolpaclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles | Drug | Neoadjuvant chemotherapy+standard therapy |
| CisplatinAlso: PlatinolCisplatin 40mg/m² given once a week during 5 weeks | Drug | Neoadjuvant chemotherapy+standard therapy, standard therapy alone |
| RadiotherapyAlso: radiation therapy45 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 | Radiation | Neoadjuvant chemotherapy+standard therapy, standard therapy alone |
Primary outcome
Overall survival
Time frame: 3 years
time between random assignment and death resulting from any cause
4 secondary outcomes
progression free survival
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
Time frame: 3 years
quality of life questionnaire C30 and CX24
Time frame: 3 years
patterns of first relapse
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 11704321Grigsby 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.
- Background: PubMed 9869224Varia 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.
- Background: PubMed 26295788Chantalat 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.
- Background: PubMed 21444871Duenas-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.
- Background: PubMed 23353129Singh 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie MOTTON, MD principal investigator
University Hospital, Toulouse
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carboplatin, Paclitaxel and Cisplatin in people with Cervical Cancer TNM Staging Regional Lymph Nodes (N), run by University Hospital, Toulouse at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie MOTTON, MD (+335 61 32 37 08 ext. 33, motton.stephanie@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534713, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.