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

NCT04016142 | Terminated Phase 2

• 3 other identifiers: ACCRAPAN-1806API-17-302018-001752-35
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

Brief 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 nodes.

Conditions

Cervical Cancer; Locally Advanced Cancer

Keywords

Adjuvant Chemotherapy; Cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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.

Study Arms (1)

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).

Drug: Carboplatin-Paclitaxel adjuvant chemotherapy

Interventions

Carboplatin-Paclitaxel adjuvant chemotherapy DRUG

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)

Also known as: Adjuvant Chemotherapy, Carboplatin-Paclitaxel

Carboplatin-Paclitaxel adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient has to suffer from a cervical cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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:
• Maintained consent

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (6)

Centre Marie Curie

Arras, France, France

Location

Centre Pierre Curie

Beuvry, France, France

Location

Centre Léonard de Vinci

Dechy, France, France

Location

Centre Oscar Lambret

Lille, France, France

Location

Clinique des dentellières

Valenciennes, France, France

Location

Centre Hospitalier de Lens

Lens, France

Location

Related Publications (32)

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Chemotherapy, Adjuvant; CP protocol

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Florence Le Tinier, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: July 11, 2019
• Study Start: July 15, 2020
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)