Study on the Effects of Carboplatin and Cisplatin in Patients with Early-Stage, Intermediate-Risk Cervical Cancer

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What is this study about?

This clinical trial is focused on studying early-stage, intermediate-risk cervical cancer. The treatment being investigated involves the use of Carboplatin and Cisplatin, which are medications given through an infusion into the vein. These medications are known as platinum-containing compounds and are commonly used in cancer treatment.

The purpose of the study is to determine if adding additional treatment with chemotherapy and radiation after surgery can help patients live longer without the cancer coming back. Participants in the study will be randomly assigned to one of two groups. One group will receive the additional treatment with chemotherapy and radiation after surgery, while the other group will not receive any further treatment after surgery. The study will follow participants over a period of time to see how well they do with each approach.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the status of their cancer. The study aims to provide valuable information on the best treatment approach for patients with this type of cervical cancer, potentially improving outcomes and quality of life for those affected by the disease.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive additional treatment after surgery, and the other group will not receive further treatment.

2 surgery

You will undergo a procedure called radical surgery to remove the cancer. This is a standard treatment for early-stage, intermediate-risk cervical cancer.

3 post-surgery treatment

If you are in the group receiving additional treatment, you will receive adjuvant (chemo)radiation. This involves receiving medication and radiation therapy to help prevent the cancer from returning.

The medications used may include carboplatin or cisplatin, which are given through an intravenous (IV) line. The specific dosage and frequency will be determined by your healthcare team.

4 follow-up

You will have regular follow-up appointments to monitor your health and check for any signs of cancer returning. These appointments will include physical exams and possibly imaging tests.

Your overall health and quality of life will be assessed through questionnaires and discussions with your healthcare team.

5 end of trial

The trial will continue until the end of 2032, but your participation may end earlier depending on your health and the trial’s progress.

The main goal is to determine if the additional treatment provides a benefit in preventing the cancer from returning.

Who Can Join the Study?

  • Must have a confirmed diagnosis of invasive cervical cancer at an early stage, specifically stages FIGO IB1 to IIA.
  • The cancer type must be either squamous cell cancer or HPV-related adenocarcinoma. Squamous cell cancer is a type of cancer that begins in the squamous cells, which are thin, flat cells that look like fish scales under a microscope. HPV-related adenocarcinoma is a type of cancer linked to the human papillomavirus (HPV) that starts in glandular cells.
  • Must have certain tumor-related risk factors, such as:
    • A tumor that is 4 cm or larger.
    • A tumor larger than 2 cm but smaller than 4 cm with lymphovascular space invasion (cancer cells found in the spaces around blood vessels or lymph vessels).
    • A tumor larger than 2 cm but smaller than 4 cm with a tumor-free distance of less than 3 mm (the distance between the tumor and the edge of the removed tissue).
    • A tumor larger than 2 cm but smaller than 4 cm with deep stromal invasion (cancer has spread deeply into the supportive tissue of the cervix).
  • No signs of suspicious pelvic lymph nodes or cancer spread to other parts of the body, based on imaging tests and final pathology results.
  • Must have an ECOG performance status of 0-1, which means the patient is fully active or has some symptoms but does not require bed rest during the day. The ECOG performance status is a scale used to assess how a patient’s disease is progressing, including their level of functioning and ability to care for themselves.
  • Must be considered suitable and healthy enough for radical surgery followed by additional radiotherapy.
  • If applicable, must have a negative pregnancy test.
  • Must have a negative HIV test if living in or having moved from high-risk countries within the past 10 years.
  • Must be female.
  • Must be within the age range of 18 to 64 years old.

Who Cannot Join the Study?

  • Patients who do not have early-stage, intermediate-risk cervical cancer cannot participate.
  • Only female patients are eligible for the study.
  • Patients who are part of a vulnerable population are not eligible. This means groups that might 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Katholieke Universiteit te Leuven Leuven Belgium
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Fakultni Nemocnice Bulovka Prague Czechia
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Fakultni Nemocnice Plzen Plzen Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
Hospital General Universitario De Valencia Valencia Spain
CHC MontLegia Liege Belgium
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Ostrava Ostrava Czechia
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
Cubhgpcbc Uwllmmhsijloqu Sjquizzhc Woluwe-Saint-Lambert Belgium
Dfwijimstwnr Cnowpwm Oktkgpjkd Pplnyhhcqnpd I Hgzuhfstlmn Wroclaw Poland
Ssihsaaxcwxkyxgj Kclczrbnsamggzbw Gdnengmuon Leoben Austria
Maoqsqx Ubyoimiasw Ol Soonutj Kdebpsyy Pyhcum Katowice Poland
Mqdemzp Uaahggldxd Op Gilv Graz Austria
Niupmjga Ibbrqwth Ooaymmfhx Iqx Mfmyc Svgvvcmrqxoazhzwwlsqxwfriqet Iqrcthnx Buaatikn Cracow Poland
Hagawucf Vqja dvfxrysc Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
20.05.2023
Belgium Belgium
Not yet recruiting
20.05.2023
Czechia Czechia
Recruiting
20.05.2023
Italy Italy
Not yet recruiting
20.05.2023
Poland Poland
Not yet recruiting
20.05.2023
Spain Spain
Recruiting
20.05.2023

Trial locations

Investigated drugs:

Adjuvant Chemotherapy is a treatment given after the main treatment, which in this trial is surgery. The goal of adjuvant chemotherapy is to kill any remaining cancer cells that might be left in the body after surgery. This helps to reduce the risk of the cancer coming back. Chemotherapy uses special drugs that target and destroy cancer cells, and it is usually given in cycles over a period of time.

Radiation Therapy is a treatment that uses high-energy rays, similar to X-rays, to target and destroy cancer cells. In this trial, radiation therapy is used after surgery to help eliminate any cancer cells that might not have been removed during the operation. This therapy is focused on the area where the cancer was located to minimize the chance of it returning.

Cervical Cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It typically begins with pre-cancerous changes in the cervical cells, often caused by persistent infection with high-risk types of human papillomavirus (HPV). As the disease progresses, these abnormal cells can develop into cancerous cells and invade deeper tissues of the cervix and surrounding areas. In its early stages, cervical cancer may not cause noticeable symptoms, but as it advances, it can lead to irregular bleeding, pelvic pain, or pain during intercourse. The progression of cervical cancer can vary, with some cases remaining localized for a long time, while others may spread to nearby tissues or distant organs. Regular screening and early detection are crucial in managing the progression of this disease.

Trial ID:
2023-504973-19-01
NCT ID:
NCT04989647
Trial Phase:
Therapeutic confirmatory (Phase III)

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