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Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer (CHRONO)

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ClinicalTrials.gov Identifier: NCT03579394
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : December 26, 2023
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Study Description
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Brief Summary:
The aim of CHRONO trial is to compare the DFS when surgery is performed after 3 courses of NACT, or after 6 courses of NACT, in a prospective multi institutional randomized setting,considering only patients initially unsuitable for primary surgery.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Stage IV Ovarian Cancer Stage IIIC Ovarian Cancer Stage IIIb Procedure: Retarded IDS (Interval Debulking Surgery) Procedure: Standard IDS (Interval Debulking Surgery) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : July 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Interval Debulking Surgery (IDS)
Complete surgery after 3 courses of neoadjuvant chemotherapy (NACT)
 Procedure: Standard IDS (Interval Debulking Surgery)

Patient will receive 3 courses of i.v carboplatine and paclitaxel every 3 weeks followed by IDS (Interval Debulking Surgery) within 6 weeks from C3D1. After surgery patient will undergo 5 more courses of carboplatine and paclitaxel chemotherapy.

Treatment accepted :

Paclitaxel and carboplatin could will be administred according to the site practice and Saint-Paul-de-Vence recommendation (Joly et al, 2017):

  • paclitaxel 175 mg/m² + carboplatin AUC 5-6, D1=D21 or
  • paclitaxel 80 mg/m² at J1-J8-J15 + carboplatin AUC 5-6, D1=D21 or
  • paclitaxel 60 mg/m² D1-D8-D15 + carboplatin AUC2 D1-D8-D15, D1= D21
  • Adjuvant therapy and maintenance (optional)according to national recommendations (Saint Paul de Vence)
Experimental: Retarded Interval Debulking Surgery (IDS)
Complete surgery after 6 courses of neoadjuvant chemotherapy (NACT)
 Procedure: Retarded IDS (Interval Debulking Surgery)

Patient will receive 6 courses of i.v carboplatine and paclitaxel every 3 weeks followed by IDS (Interval Debulking Surgery) within 6 weeks from C6D1. After surgery patient will undergo 2 more courses of carboplatine and paclitaxel chemotherapy

Treatment accepted :

Paclitaxel and carboplatin could will be administred according to the site practice and Saint-Paul-de-Vence recommendation (Joly et al, 2017):

  • paclitaxel 175 mg/m² + carboplatin AUC 5-6, D1=D21 or
  • paclitaxel 80 mg/m² at J1-J8-J15 + carboplatin AUC 5-6, D1=D21 or
  • paclitaxel 60 mg/m² D1-D8-D15 + carboplatin AUC2 D1-D8-D15, D1= D21
  • Adjuvant therapy and maintenance (optional)according to national recommendations (Saint Paul de Vence)


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free Survival [ Time Frame: From date of randomisation until the date of second cancer or death, which ever occurs earlier, assessed up to 5 years ]
    Disease free survival (DFS) defined as the time interval between randomization and physical or radiographic evidence of recurrence (local/distant) or second cancer or death (all causes) whichever occur first


Secondary Outcome Measures :
  1. EORTC QLQ-C30 [ Time Frame: through study completion, up to 2 years ]
    Health related quality of life of the patient

  2. Pathological complete response (PCR) [ Time Frame: through study completion, up to 2 years ]
    Pathological response will be established using the grading system called chemotherapy response score (CRS). The response will be assessed based on the omentum microscopic review.

  3. Overall survival (OS) [ Time Frame: from date of randomisation to death, assessed up to 5 years ]
    Overall survival (OS) defined as time interval between randomization and death (all causes); alive patients will be censored at the last date of news

  4. Time for first subsequent treatment (TFST) [ Time Frame: up to 5 years ]
  5. Post-operative mortality [ Time Frame: up to 5 months ]
    Post operative mortality defined as the interval between the date of debulking surgery and the date of death due to any cause occurring within the 30 day post-surgery

  6. Post-operative morbidity [ Time Frame: up to 5 months ]
    Surgical morbidity defined as the interval between the date of debulking surgery and any events occurring within the 30 day post-surgery (All grades ≥ 3 according to the CTCAE v4.03 & All grades ≥ 3 according to Clavien Dindo classification)

  7. Fagotti laparoscopic score [ Time Frame: diagnosis ]
    Disease extension assessed by Fagotti score at the time of diagnosis https://www.ncbi.nlm.nih.gov/pubmed/16791447

  8. CTC-AE version 4.03 adverse events [ Time Frame: 30 days after last treatment intake, up to 1 year ]
    safety assessment

  9. questionnaire OV28 [ Time Frame: through study completion, up to 2 years ]
    Physical, abdominal/gastrointestinal (GI), fatigue


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients ≥18 years.
  2. Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma, high grade serous or endometrioïd, with the exception of mucinous, clear cell and carcinosarcoma histologies.
  3. Performance status < 2 (see Appendix 2).
  4. Documented International Federation of Gynecologic Oncology (FIGO 2014, Appendix 1) stage IIIB-IIIC-IVa unsuitable for complete primary cytoreductive surgery (confirmed by open laparoscopy or by laparotomy [not mandatory for stage IVA]).
  5. Patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy

  6. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:

    • White blood cells (WBC) >3x109/L, absolute neutrophil count (ANC) ≥1,5x109/L, platelets (PLT)

      ≥100x109/L, hemoglobin (Hb) ≥9 g/dL,

    • Serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥ 30 mL/min according to Cockroft-Gault formula or to local lab measurement, serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
  7. Signed informed consent obtained prior to any study-specific procedures.
  8. Patient affiliated to, or a beneficiary of, a social security category

Exclusion Criteria:

  1. Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.
  2. Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites).
  3. Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage before 6 months from the enrollment on this study.
  4. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired respiratory function requiring oxygen-dependence, serious psychiatric disorders).
  5. Pregnant or breastfeeding women.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579394


Contacts
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Contact: Mihary ANDRIAMAMONJY +33(0)-1-84-85-20-09 mandriamamonjy@arcagy.org

Locations
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Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
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Principal Investigator: Jean-Marc Classe, MD, PhD Institut de Cancérologie de l'Ouest
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT03579394    
Other Study ID Numbers: GINECO-CHIR101
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: December 26, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARCAGY/ GINECO GROUP:
ovarian cancer
retarded surgery
neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type