Study on Adjusting Chemotherapy with Carboplatin and Paclitaxel for Patients with Poor Prognostic Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying ovarian cancer, specifically in patients who have a poor prognosis due to the cancer’s resistance to initial chemotherapy and incomplete surgical removal of the tumor. The study will explore the effectiveness of a new treatment approach using a combination of carboplatin and paclitaxel, which are chemotherapy drugs. These drugs are typically used to treat ovarian cancer, but this trial will test a new dosing schedule that involves more frequent, smaller doses, known as a “weekly dose-dense regimen.” The goal is to see if this new approach is more effective than the standard treatment, which involves larger doses given every three weeks.

In addition to carboplatin and paclitaxel, the study will also involve the use of bevacizumab, a medication that helps prevent the growth of blood vessels that supply the tumor, and filgrastim, which is used to boost white blood cell counts and help the body fight infections during chemotherapy. Some patients in the study will receive a placebo instead of bevacizumab to compare the effects. The trial aims to determine if the new treatment plan can improve outcomes for patients, such as increasing the chances of successful surgery and extending survival times.

Participants in the study will receive treatment over a period of up to 64 weeks. The study will monitor various outcomes, including the overall response to treatment, progression-free survival (the time during which the cancer does not get worse), and overall survival. The trial will also assess the quality of life of participants and gather information on any side effects experienced. The findings from this study could help improve treatment strategies for patients with ovarian cancer who have a poor prognosis.

1 joining the trial

Upon joining the trial, eligibility is confirmed based on specific criteria, including age, diagnosis, and previous treatment history.

Consent is required to participate in the study, ensuring understanding of the trial’s purpose and procedures.

2 initial treatment phase

The initial treatment involves receiving a standard chemotherapy regimen consisting of carboplatin and paclitaxel every three weeks for 3 to 4 cycles.

This phase assesses the response to the standard treatment and determines eligibility for the next phase based on specific criteria, such as the KELIM score, which measures chemosensitivity.

3 randomization and treatment adjustment

Participants are randomly assigned to either continue the standard chemotherapy regimen or switch to a weekly dose-dense regimen.

The weekly dose-dense regimen involves more frequent administration of carboplatin and paclitaxel to potentially improve treatment outcomes.

4 additional medication

During the trial, additional medications such as filgrastim may be administered to support blood cell production.

Bevacizumab may also be included in the treatment plan to inhibit tumor growth by targeting blood vessel formation.

5 monitoring and follow-up

Regular monitoring through scheduled visits and examinations is conducted to assess treatment effectiveness and manage any side effects.

Follow-up includes evaluating overall response, progression-free survival, and quality of life through questionnaires and medical assessments.

6 completion of trial

The trial is expected to conclude by the end of 2028, with ongoing assessments of survival rates and treatment outcomes.

Participants may continue to receive follow-up care and monitoring as part of the study’s long-term evaluation.

Who Can Join the Study?

  • Patients must have a confirmed diagnosis of high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. This includes specific types like serous, endometrioid, or carcinosarcoma with at least 30% of the tumor being epithelial.
  • Patients must be adults, aged 18 years or older.
  • The disease must be at an advanced stage, specifically stage III or IV.
  • Patients should have been treated with 3 to 4 cycles of a standard chemotherapy regimen called carboplatin-paclitaxel before joining the study. They should have a poor response to this treatment, shown by an unfavorable KELIM score of less than 1.0. This score is a measure of how the cancer responds to chemotherapy. Additionally, the cancer should not be suitable for complete surgical removal.
  • Patients must have an ECOG performance status of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Patients need to have adequate organ and bone marrow function to handle the chemotherapy. This includes having enough red blood cells, white blood cells, and platelets.
  • Patients must have proper kidney and liver function. This includes specific levels of liver enzymes, bilirubin, albumin, and creatinine clearance, which are measures of how well the liver and kidneys are working.
  • Patients must provide written consent to participate in the study.
  • Patients must be affiliated with a social insurance regime.
  • Patients must be willing and able to follow the study protocol, which includes attending treatment sessions, scheduled visits, and examinations.

Who Cannot Join the Study?

  • Patients with poor prognostic ovarian cancers. This means the cancer does not respond well to treatment and surgery cannot remove all of it.
  • Patients who have a poor chemosensitivity. This means the cancer does not respond well to chemotherapy.
  • Patients with an unfavorable KELIMTM score less than 1.0. This score helps predict how well the cancer will respond to treatment.
  • Patients whose disease cannot be completely removed by surgery.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population are not eligible. This refers to groups of people who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Clinique Pasteur Toulouse France
Hôpital Européen Georges-Pompidou Paris France
Centre Hospitalier Intercommunal Creteil Creteil France
Comite Entreprise Paul Papin Angers France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Aix Marseille University Marseille France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Antoine Lacassagne Nice France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Azienda Ulss 3 Serenissima Venice Italy
Institut Godinot Reims France
Hopital Prive De La Loire Saint-Etienne France
Centre Hospitalier D Avignon Avignon France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier Alpes Leman 74130 France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Alessandro Manzoni Hospital Lecco Italy
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier De Cholet Cholet France
Hopital Prive Des Cotes D’armor Plerin France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Institut Sainte Catherine Avignon France
Societe De Recherche Oncologique Clinique 37 Chambray Les Tours France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Centre Hospitalier De Pau Pau France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Oncoradio Centre Oncogard Nimes France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Injlgsfh Rzvmiavv Dm Ckmvrp Dm Mkszwwqtzfr Montpellier France
Czqyom Ldsf Bntlwa Lyon France
Leafm Utojavlisued Mbmhprs Ciwskxz (rynxd Leiden The Netherlands
Cijxna Harrqthnyfj Vxvdjlp Valence France
Igwxbmpa Bmuuiavb Bordeaux France
Hcdhsxhh dp Lxxeb Thonon-les-bains France
Cez Digod Bmktlpkqw Hfbnlhc Frpggdfq Mnuezbwzl Dijon France
Cczdkf Aykpkvi dx Cjajgzyzkrar Mougins France
Clcvlg Howvizdtwvg Ef Ufpcculsmqbdb Dz Lduhfen Limoges France
Spwjlskbk Rmuqmxz Utczftzvfd Mggzzkn Ccwglc Nijmegen The Netherlands
Bardovbj Uyrvixrmio Hittpctl Czwrcq Besançon France
Ewbwxoe Urstdbxpbyxg Mkxuitr Cepuxni Rtnqzzeyp (nxkgiex Mmi Rotterdam The Netherlands
Aqxmiix Odwdszuuobe Najlgyfgy Sh Avrfpbc E Bnzcpt E C Agewnz Adamoeqwvhm Alexandria Italy
Aujpsgf Uepgr Szujnzcul Lwjofw Du Bbzwezo Bologna Italy
Iamubdxf ds Clfsmxojcnez Hhkmuqyvueg Uumpiafonqqtt df Sqclm Equdwjc (scfslth Saint Priest En Jarez France
Cnhcxi Oheec Lszhdnp Lille France
Hmhjfdkt Ufibddklwqhtfo Sgaqdhnljv &hplleg Hzzcmli dl Htbzfafsfor STRASBOURG, Alsace France
Ierfaooe Chgub Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
31.05.2024
Italy Italy
Recruiting
31.05.2024
The Netherlands The Netherlands
Not yet recruiting
31.05.2024

Trial locations

Carboplatin is a chemotherapy medication used to treat ovarian cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, carboplatin is used as part of a treatment regimen to evaluate its effectiveness in patients with poor prognostic ovarian cancer.

Paclitaxel is another chemotherapy drug used in the treatment of ovarian cancer. It helps stop the growth of cancer cells by inhibiting their ability to divide. In the trial, paclitaxel is combined with carboplatin to assess whether a more frequent dosing schedule can improve outcomes for patients with challenging cases of ovarian cancer.

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands. It often goes undetected until it has spread within the pelvis and abdomen, making it more challenging to treat. The disease is characterized by the growth of abnormal cells that have the ability to invade or spread to other parts of the body. Symptoms can be vague and may include bloating, pelvic pain, and difficulty eating. The progression of ovarian cancer can vary, with some tumors being more aggressive and others growing more slowly. Factors such as tumor chemosensitivity and the success of surgical removal can influence the disease’s progression.

Trial ID:
2023-508260-30-01
Protocol code:
GINECO-OV130b
Trial Phase:
Therapeutic confirmatory (Phase III)

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