Combined treatment of intraperitoneal chemotherapy after optimal interval surgery in advanced ovarian cancer. BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia, Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

27 Feb 2023 → ongoing

Decision date (initial)

2023-06-21

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2022-502691-23-00

EudraCT number

2022-001107-41

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

This is a non-commercial clinical study whose main objective is to: Investigate whether the combined administration of HIPEC with cisplatin (100 mg/m2 body surface area) and postoperative bidirectional chemotherapy (intraperitoneal and systemic) after cytoreduction is feasible, effective and safe in patients with IIIB-C/IV ovarian cancer treated with neoadjuvant systemic chemotherapy:
The safety of the combined treatment will be evaluated by collecting the complications and adverse effects that are generated in the study patients, which will be compared to the morbidity and mortality described in the scientific literature.
Efficacy will be assessed in terms of overall survival and survival disease free at 1, 3 and 5 years. This overall survival will be defined as the interval of time elapsed from the surgical intervention to the death of the patient. The disease-free interval is defined as the time elapsed from surgery to occurrence of disease recurrence. For this, the study will take into account criteria of recurrence currently accepted. These include an elevation of CA125 >70 U/mL if after treatment it was <35U/mL, or an elevation to twice the lowest value obtained with treatment if CA125 did not normalize after treatment. The definitive diagnosis of recurrence must be accompanied either by the appearance of new lesions in studies of imaging or pathological confirmation.

Secondary objectives 1

1. Evaluate the Quality of Life parameters of the patients before surgery, before the start of treatment and after its completion (3 and 6 months).

Conditions and MedDRA coding

Ovarian cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Women between 18-70 years of age with a proven histological diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer (high-grade serous epithelial carcinoma).
2. Absence of extraperitoneal disease.
3. Adequate functional status: Karnofsky index >70 or Performance status ≤ 2
4. Correct liver function, defined as bilirubin <0 1.5 times the upper limit of normal (ULN), aspartate amino transferase and alanine amino transferase ≤ 2.5 times ULN, and alkaline phosphate ≤ 3 times ULN
5. Correct renal function, defined as serum creatinine ≤ 1.5 times ULN
6. Acceptable bone marrow function defined as neutrophils >1.5 x 106 l-1, hemoglobin > 10 g/dl-1 and platelets >100.0 x 109 l-1
7. Absence of cardiac, pulmonary, hepatic, renal, or neurological disease that contraindicates major surgery.
8. Negative result in serum and urine pregnancy test for women of childbearing age at screening visit.
9. Administration of neoadjuvant chemotherapy with a total of 3 systemic cycles.
10. CC0 complete cytoreduction without digestive anastomosis.
11. Patients who have signed the written informed consent (IC).

Exclusion criteria 9

1. Disease progression after initiation of systemic neoadjuvant chemotherapy.
2. Extraperitoneal disease (including retroperitoneal nodal metastases) at reassessment after systemic neoadjuvant therapy.
3. Impossibility of achieving complete cytoreduction (CC-0).
4. Active infection of any origin.
5. Allogeneic transplant, or prior bone marrow transplant, or high-dose chemotherapy with bone marrow or stem cell rescue.
6. Participation in a clinical trial with an investigational drug in the last 30 days.
7. Pregnant or lactating women, where pregnancy is defined as the state of a woman after conception and until the end of gestation, confirmed by a positive human chorionic gonadotropin (hCG) test result, or who plans to become pregnant o plan to breast-feed during study treatment or within 30 days of cessation of study drug treatment.
8. Patients with a history of allergic reactions or hypersensitivity to drugs chemically related to cisplatin and paclitaxel.
9. Failure to sign the written informed consent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The safety variable of the study will be postoperative Morbidity and Mortality. Morbidity will be defined based on the NCI‐CTCAE v4 scale classification.
2. The variables related to the treatment effectiveness will be disease free and overall survival.

Secondary endpoints 1

1. The secondary variable will be the patients' life quality once treatment finished, evaluated using the EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Sponsor organisation

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Address

Carretera De Cartagena S/n, El Palmar El Palmar

City

Murcia

Postcode

30120

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Contact name

Clinical trial information desk

Public contact point

Organisation

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Contact name

Clinical trial information desk

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Sponsor organisation

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Address

Carretera Madrid-Cartagena S/N, El Palmar El Palmar

City

Murcia

Postcode

30120

Country

Spain

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications