Clinical trial NCT03579394: Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
Official title: CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Cancer Stage IV
Ovarian Cancer Stage IIIC
Ovarian Cancer Stage IIIb
Keywords: ovarian cancer
retarded surgery
neoadjuvant chemotherapy
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 211
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Disease Free Survival
timeFrame: From date of randomisation until the date of second cancer or death, which ever occurs earlier, assessed up to 5 years
Secondary outcomes:
measure: EORTC QLQ-C30
timeFrame: through study completion, up to 2 years
measure: Pathological complete response (PCR)
timeFrame: through study completion, up to 2 years
measure: Overall survival (OS)
timeFrame: from date of randomisation to death, assessed up to 5 years
measure: Time for first subsequent treatment (TFST)
timeFrame: up to 5 years
measure: Post-operative mortality
timeFrame: up to 5 months
measure: Post-operative morbidity
timeFrame: up to 5 months
measure: Fagotti laparoscopic score
timeFrame: diagnosis
measure: CTC-AE version 4.03 adverse events
timeFrame: 30 days after last treatment intake, up to 1 year
measure: questionnaire OV28
timeFrame: through study completion, up to 2 years
Other outcomes:
Locations:
city: Avignon
country: France
facility: ICA - Polyclinique Urbain V
city: Bordeau
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: CHU de BREST - Hôpital Cavale Blanche
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: Centre Hospitalier Universitaire Caen
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Eaubonne
country: France
facility: Hôpital Simone Veil
city: Grenoble
country: France
facility: CHU Grenoble-Alpes - Site Nord (La Tronche)
city: Le Mans
country: France
facility: Centre Jean Bernard - Clinique Victor Hugo
city: Limoges
country: France
facility: CHU de Limoges - Hôpital de la Mère et de l'Enfant
city: Lorient
country: France
facility: Hôpital du Scorff
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hôpital Mère et Enfant
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpétrière
city: Poitiers
country: France
facility: Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint-cloud
country: France
facility: Hôpital René Huguenin, Institut Curie
city: Saint-herblain
country: France
facility: ICO Centre René Gauducheau
city: Sainte Foy-les-Lyon
country: France
facility: Clinique Médico-chirurgicale CHARCOT
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Jean-Marc Classe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Classe JM, Ferron G, Ouldamer L, Gauthier T, Emambux S, Gladieff L, Dupre PF, Anota A. CHRONO: randomized trial of the CHROnology of surgery after Neoadjuvant chemotherapy for Ovarian cancer. Int J Gynecol Cancer. 2022 Aug 1;32(8):1071-1075. doi: 10.1136/ijgc-2021-003320.