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Status:

TERMINATED

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

Lead Sponsor:

Centre Oscar Lambret

Conditions:

Locally Advanced Cancer

Cervical Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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 ext...

Detailed Description

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 ext...

Eligibility Criteria

Inclusion

  • PART 1:
  • 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

Exclusion

  • 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:
  • Inclusion Criteria:
  • 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.

Key Trial Info

Start Date :

July 15 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2025

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT04016142

Start Date

July 15 2020

End Date

January 31 2025

Last Update

February 4 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Centre Marie Curie

Arras, France, France

2

Centre Pierre Curie

Beuvry, France, France

3

Centre Léonard de Vinci

Dechy, France, France

4

Centre Oscar Lambret

Lille, France, France