Locally Advanced CancerPhase 2ACCRAPANNCT04016142

Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer

A Phase 2 study testing Carboplatin-Paclitaxel adjuvant chemotherapy in people with Locally Advanced Cancer and Cervical Cancer, run by Centre Oscar Lambret at 6 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Locally Advanced Cancer, Cervical Cancer
What is being tested?: Carboplatin-Paclitaxel adjuvant chemotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 6 sitesFrance
Study dates: 15 Jul 2020to 31 Jan 2025
Phase: Phase 2
Are there results?: None posted in the registry

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

Female patient aged more than 18 years old
Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
With locally advanced cervical cancer (FIGO stage IIIC2)
With para-aortic or iliac common nodes positive on PET-scan or after laparoscopic surgical staging if PET-scan negative
ECOG Performance Status ≤ 2
Adequate hematologic function: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10g/dL

Show all 21Show fewer

Adequate renal function: creatinine clearance (estimated according to MDRD formula) ≥ 60ml/min/1.73m²
Adequate hepatic function: Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤ 2.5 × upper normal limit (UNL); Total bilirubin ≤ 1.5 x UNL (except in case of Gilbert's disease)
Negative serum pregnancy test within 7 days prior to treatment for women of childbearing potential. For non-menopaused women, if not surgically sterilized, willing to accept the use of an effective contraceptive regimen during the treatment period and at least 6 months after the end of treatment
Absence of contraindication to receive the products used in this study (products used in concomitant/ adjuvant chemotherapy) according to the most recent SmPC of these products (available at http://base-donnees-publique.medicaments.gouv.fr/)
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
Patient covered by the French "Social Security" regime
Signed informed consent form
Maintained consent
Adequate hematologic function: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10g/dL
Adequate renal function: creatinine clearance (estimated according to MDRD formula) ≥ 60ml/min/1.73m2
Adequate hepatic function: Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤ 2.5 × upper normal limit (UNL); Total bilirubin ≤ 1.5 x UNL (except in case of Gilbert's disease)
Patient having received curative intent chemo-radiation therapy with the following recommendations:
extended field CT-RT delivered by IMRT: 45-50Gy according the dosimetry limitation histogram dose volume (HDV) in whole pelvis and Para Aortic volumes + concomitant boost on macroscopic nodes defined as PET-positive
associated with weekly Cisplatin (40mg/m²)
followed by image guided brachytherapy. Patient will be eligible even in case of temporary stop of radiation therapy, provided she has received a total dose of 45Gy and a concomitant boost. Patient should have received at least 3 injections of Cisplatin 40mg/m² during radiation therapy.

Who cannot join

Histological diagnosis of sarcoma
Previous hysterectomy or planned hysterectomy as part of their initial cervix cancer therapy,
Presence of distant metastases other than lombo-aortic lymph nodes
Patient with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
Patient with bilateral hydronephrosis unless at least one side has been stented
Prior diagnosis of Crohn's disease or ulcerative colitis or sclerodermia

Show all 20Show fewer

Other uncontrolled intercurrent disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
Pregnant or breastfeeding woman,
Participation in another therapeutic trial with an experimental molecule for the current disease
Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent
Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
Person under guardianship or curatorship
PART 2:
Progression during Part 1,
Contraindication for one of the study drug in particular the residual toxicity of Part 1 (radio-chemotherapy) such as:
Renal failure (defined as creatinine clearance according to MDRD formula < 60 mL/ min/1.73m2),
Any clinical residual toxicity (including peripheral neuropathy) ≥ grade 2 (as per CTCAE v5),
Radiation therapy prematurely stopped (total dose on whole pelvis and on nodes not received)
Cumulative dose of Cisplatin received less than 120 mg/m².

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

France6 sites

Centre Marie Curie
Arras, France
Centre Pierre Curie
Beuvry, France
Centre Léonard de Vinci
Dechy, France
Centre Hospitalier de Lens
Lens
Centre Oscar Lambret
Lille, France
Clinique des dentellières
Valenciennes, France

Other trials in France

About this study

Official title: Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes

Read the detailed description

Patients

will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study").
will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment).

The primary objective is to evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.

Conditions: Locally Advanced Cancer, Cervical Cancer
Being tested: Carboplatin-Paclitaxel adjuvant chemotherapy
Keywords: Adjuvant Chemotherapy, Cervical cancer
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.

Carboplatin-Paclitaxel adjuvant chemotherapyDrug
Also called Adjuvant Chemotherapy, Carboplatin-Paclitaxel
Patients will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study").
Then, they will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage.
The second part consists in 4 cycles of Carboplatin-Paclitaxel adjuvant chemotherapy (one cycle = 3 weeks of treatment and 1 free-week)

Study groups in NCT04016142
Study group	Role	What they receive
Carboplatin-Paclitaxel adjuvant chemotherapy	Experimental	Patients * will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study"). * will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment). Receives: Drug: Carboplatin-Paclitaxel adjuvant chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival with adjuvant chemotherapy
To evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.
Progression will be based on a MRI scan, done during the usual oncologic follow-up: every 3 months during the 2 first years after radio-chemotherapy, and then every 6 months during 3 years.
Progression will be evaluated with RECIST criteria v1.1. The main analysis of this phase II trial will focus on the 2-year PFS rate from inclusion in the Part 2, but the whole curve will be estimated.
Measured: From the date of inclusion in the Part 2 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 64 months.

Secondary outcomes (8)

Overall Survival with adjuvant chemotherapy
To evaluate efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel in terms of Overall Survival (OS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.
OS will be estimated with the Kaplan-Meier method.
Measured: From the date of inclusion in the Part 2 of the study until the date of death whatever the cause. Assessed up to 64 months.
Metastasis Free Survival with adjuvant chemotherapy
To evaluate efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel in terms of Metastasis Free Survival (MFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.
Metastatic progressions will be evaluated with the RECIST criteria.
Measured: From the date of inclusion in the Part 2 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 64 months.
Number of Cycles Received of adjuvant chemotherapy
To describe feasibility of adjuvant chemotherapy in terms of number of cycles received, separately for each molecule Carboplatin and Paclitaxel.
The number of cycles will be recorded in the data base with the date and doses of injections, allowing the calculation of the Relative Dose Intensity.
Reasons of treatment stop or dose modification will also be recorded.
Measured: From the date of inclusion in the Part 2 of the study until the date of adjuvant chemotherapy ending or patient study output or death whatever the cause. Up to 4 months.
Progression Free Survival with concomitant chemo-radiotherapy associated to brachytherapy
To evaluate the efficacy of adjuvant chemotherapy with concomitant chemo-radiotherapy associated to brachytherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.
Progression will be based on a MRI scan, done during the usual oncologic follow-up: every 3 months during the 2 first years after radio-chemotherapy, and then every 6 months during 3 years.
Progression will be evaluated with RECIST criteria v1.1.
Measured: From the date of inclusion in the Part 1 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 67 months.
Overall Survival with concomitant chemo-radiotherapy associated to brachytherapy
To evaluate efficacy of concomitant chemo-radiotherapy associated to brachytherapy in terms of Overall Survival (OS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.
OS will be estimated with the Kaplan-Meier method.
Measured: From the date of inclusion in the Part 1 of the study until the date of death whatever the cause. Assessed up to 67 months.
Metastasis Free Survival with concomitant chemo-radiotherapy associated to brachytherapy
To evaluate efficacy of concomitant chemo-radiotherapy associated to brachytherapy in terms of Metastasis Free Survival (MFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.
Metastatic progressions will be evaluated with the RECIST criteria.
Measured: From the date of inclusion in the Part 1 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 67 months.
Number of Cycles Received of concomitant chemo-radiotherapy associated to brachytherapy
To describe feasibility of the concomitant chemo-radiotherapy associated to brachytherapy (Part 1 of the study) in terms of number of cycles received.
The number of cycles will be recorded in the data base with the date and doses of injections, allowing the calculation of the Relative Dose Intensity.
Reasons of treatment stop or dose modification will also be recorded.
Measured: From the date of inclusion in the Part 1 of the study until the date of concomitant chemo-radiotherapy associated to brachytherapy ending or patient study output or death whatever the cause. Assessed up to 12 weeks.
Safety of the whole treatment
To describe safety of the whole treatment (part 1 \& 2) in terms of Adverse Event.
During the first part of the study (concomitant radio-chemotherapy), all AE (Adverse Events) will be reported. AE occurring after end of treatment will not be collected for patients withdrawn from the study at the end of the first part. For the second part of the study (adjuvant chemotherapy), all AE will be reported up to 30 days after the end of adjuvant chemotherapy, until progression if any. Then, only AE possibly related to chemotherapy or radiation therapy will be collected, up to 5 years after the end of radiation therapy or until progression (whichever occurs first). All AE will be graded using the NCI-CTCAE v5.0 and AE of grade >2 will be considered as severe AE.
Measured: From the date of inclusion in the Part 1 of the study, up to 5 years after the end of radiation therapy or until progression (whichever occurs first).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202031 Jan 2025

First posted11 Jul 2019
Study start15 Jul 2020
Primary completion31 Jan 2025
Study completion31 Jan 2025

Why it stopped: The study is discontinued because of recruitment failure, and for strategic reason (competitive trials with immunotherapy)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Locally Advanced CancerStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04016142
Sponsor's protocol ID: ACCRAPAN-1806
Other IDs: API-17-30, 2018-001752-35, 2018
Acronym: ACCRAPAN
Status last verified: Mar 2026
First submitted: 31 May 2019
Last updated: 18 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH; ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006 Dec;100(3):255-62. doi: 10.1007/s10549-006-9254-4. Epub 2006 May 17.
PubMed 16705366
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
Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6.
PubMed 22554549
Leblanc E, Narducci F, Frumovitz M, Lesoin A, Castelain B, Baranzelli MC, Taieb S, Fournier C, Querleu D. Therapeutic value of pretherapeutic extraperitoneal laparoscopic staging of locally advanced cervical carcinoma. Gynecol Oncol. 2007 May;105(2):304-11. doi: 10.1016/j.ygyno.2006.12.012. Epub 2007 Jan 29.
PubMed 17258799
Grigsby PW. The prognostic value of PET and PET/CT in cervical cancer. Cancer Imaging. 2008 Jul 24;8(1):146-55. doi: 10.1102/1470-7330.2008.0022.
PubMed 18694852
Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.
PubMed 15050330
Ahmed RS, Kim RY, Duan J, Meleth S, De Los Santos JF, Fiveash JB. IMRT dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):505-12. doi: 10.1016/j.ijrobp.2004.03.035.
PubMed 15380585
Rotman M, Pajak TF, Choi K, Clery M, Marcial V, Grigsby PW, Cooper J, John M. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA. 1995 Aug 2;274(5):387-93.
PubMed 7616634
Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004 Mar 1;22(5):872-80. doi: 10.1200/JCO.2004.07.197.
PubMed 14990643
Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
PubMed 10202164
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 11704321
Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1354-60. doi: 10.1016/s0360-3016(03)00325-0.
PubMed 12873680
Cihoric N, Tapia C, Kruger K, Aebersold DM, Klaeser B, Lossl K. IMRT with (1)(8)FDG-PET\CT based simultaneous integrated boost for treatment of nodal positive cervical cancer. Radiat Oncol. 2014 Mar 25;9:83. doi: 10.1186/1748-717X-9-83.
PubMed 24661323
Vargo JA, Kim H, Choi S, Sukumvanich P, Olawaiye AB, Kelley JL, Edwards RP, Comerci JT, Beriwal S. Extended field intensity modulated radiation therapy with concomitant boost for lymph node-positive cervical cancer: analysis of regional control and recurrence patterns in the positron emission tomography/computed tomography era. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1091-8. doi: 10.1016/j.ijrobp.2014.08.013. Epub 2014 Oct 8.
PubMed 25303889
Perry LJ, Mathews C, Nugent E, Farrell R, Zorn K, Moore K. Outcomes of cervical cancer and positive para-aortic lymph nodes in the modern era of chemoradiation. Int J Gynecol Cancer. 2014 Mar;24(3):564-9. doi: 10.1097/IGC.0000000000000093.
PubMed 24552890

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes
ClinicalTrials.gov ID: NCT04016142
Acronym / sponsor ID: ACCRAPAN / ACCRAPAN-1806
Conditions: Locally Advanced Cancer, Cervical Cancer
Keywords: Adjuvant Chemotherapy, Cervical cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study is discontinued because of recruitment failure, and for strategic reason (competitive trials with immunotherapy)
Enrolment: 21 participants (actual)
Lead sponsor: Centre Oscar LambretUniversity, hospital or other
Study start: 15 Jul 2020 (actual)
Primary completion: 31 Jan 2025 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 11 Jul 2019 (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.

Detailed description

Patients

will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study").
will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Carboplatin-Paclitaxel adjuvant chemotherapy	Experimental	Drug: Carboplatin-Paclitaxel adjuvant chemotherapyPatients * will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study"). * will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Female patient aged more than 18 years old
Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
With locally advanced cervical cancer (FIGO stage IIIC2)
With para-aortic or iliac common nodes positive on PET-scan or after laparoscopic surgical staging if PET-scan negative
ECOG Performance Status ≤ 2

Key exclusion criteria (20 listed)

Histological diagnosis of sarcoma
Previous hysterectomy or planned hysterectomy as part of their initial cervix cancer therapy,
Presence of distant metastases other than lombo-aortic lymph nodes
Patient with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
Patient with bilateral hydronephrosis unless at least one side has been stented

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
Carboplatin-Paclitaxel adjuvant chemotherapyAlso: Adjuvant Chemotherapy, Carboplatin-PaclitaxelPatients will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study"). Then, they will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage. The second part consists in 4 cycles of Carboplatin-Paclitaxel adjuvant chemotherapy (one cycle = 3 weeks of treatment and 1 free-week)	Drug	Carboplatin-Paclitaxel adjuvant chemotherapy

Primary outcome

Progression Free Survival with adjuvant chemotherapy
Time frame: From the date of inclusion in the Part 2 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 64 months.
To evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. Progression will be based on a MRI scan, done during the usual oncologic follow-up: every 3 months during the 2 first years after radio-chemotherapy, and then every 6 months during 3 years. Progression will be evaluated with RECIST criteria v1.1. The main analysis of this phase II trial will focus on the 2-year PFS rate from inclusion in the Part 2, but the whole curve will be estimated.

8 secondary outcomes

Overall Survival with adjuvant chemotherapy
Time frame: From the date of inclusion in the Part 2 of the study until the date of death whatever the cause. Assessed up to 64 months.
Metastasis Free Survival with adjuvant chemotherapy
Time frame: From the date of inclusion in the Part 2 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 64 months.
Number of Cycles Received of adjuvant chemotherapy
Time frame: From the date of inclusion in the Part 2 of the study until the date of adjuvant chemotherapy ending or patient study output or death whatever the cause. Up to 4 months.
Progression Free Survival with concomitant chemo-radiotherapy associated to brachytherapy
Time frame: From the date of inclusion in the Part 1 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 67 months.
Overall Survival with concomitant chemo-radiotherapy associated to brachytherapy
Time frame: From the date of inclusion in the Part 1 of the study until the date of death whatever the cause. Assessed up to 67 months.
Metastasis Free Survival with concomitant chemo-radiotherapy associated to brachytherapy
Time frame: From the date of inclusion in the Part 1 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 67 months.
Number of Cycles Received of concomitant chemo-radiotherapy associated to brachytherapy
Time frame: From the date of inclusion in the Part 1 of the study until the date of concomitant chemo-radiotherapy associated to brachytherapy ending or patient study output or death whatever the cause. Assessed up to 12 weeks.
Safety of the whole treatment
Time frame: From the date of inclusion in the Part 1 of the study, up to 5 years after the end of radiation therapy or until progression (whichever occurs first).

Results and safety

The study was stopped early (reason given: The study is discontinued because of recruitment failure, and for strategic reason (competitive trials with immunotherapy)). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Background: PubMed 16705366Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH; ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006 Dec;100(3):255-62. doi: 10.1007/s10549-006-9254-4. Epub 2006 May 17.
Background: PubMed 19001332Chemoradiotherapy 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.
Background: PubMed 22554549Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6.
Background: PubMed 17258799Leblanc E, Narducci F, Frumovitz M, Lesoin A, Castelain B, Baranzelli MC, Taieb S, Fournier C, Querleu D. Therapeutic value of pretherapeutic extraperitoneal laparoscopic staging of locally advanced cervical carcinoma. Gynecol Oncol. 2007 May;105(2):304-11. doi: 10.1016/j.ygyno.2006.12.012. Epub 2007 Jan 29.
Background: PubMed 18694852Grigsby PW. The prognostic value of PET and PET/CT in cervical cancer. Cancer Imaging. 2008 Jul 24;8(1):146-55. doi: 10.1102/1470-7330.2008.0022.
Background: PubMed 15050330Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.
Background: PubMed 15380585Ahmed RS, Kim RY, Duan J, Meleth S, De Los Santos JF, Fiveash JB. IMRT dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):505-12. doi: 10.1016/j.ijrobp.2004.03.035.
Background: PubMed 7616634Rotman M, Pajak TF, Choi K, Clery M, Marcial V, Grigsby PW, Cooper J, John M. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA. 1995 Aug 2;274(5):387-93.
Background: PubMed 14990643Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004 Mar 1;22(5):872-80. doi: 10.1200/JCO.2004.07.197.
Background: PubMed 10202164Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
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 12873680Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1354-60. doi: 10.1016/s0360-3016(03)00325-0.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Florence Le Tinier, MD principal investigator

Centre Oscar Lambret

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin-Paclitaxel adjuvant chemotherapy in people with Locally Advanced Cancer and Cervical Cancer, run by Centre Oscar Lambret at 6 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 21 inclusion and 20 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: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival with adjuvant chemotherapy (time frame: From the date of inclusion in the Part 2 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 64 months.). 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 NCT04016142, which also lists 32 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 18 Mar 2026.