Study on Reducing Treatment Intensity for Patients with HPV-Positive Oropharyngeal Cancer Using Cisplatin and Carboplatin

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What is this study about?

This clinical trial is focused on studying Human papillomavirus (HPV)-positive oropharyngeal cancer, a type of throat cancer linked to the HPV virus. The study aims to explore the effects of reducing the intensity of additional treatments after surgery, specifically looking at how this might improve swallowing function and reduce side effects. The treatments being studied include two chemotherapy drugs, Cisplatin and Carboplatin, which are given through an intravenous infusion, meaning they are administered directly into the bloodstream through a vein.

The purpose of the study is to determine if a less intense treatment approach can maintain the same level of effectiveness in terms of overall survival while improving the quality of life for patients. Participants in the study will undergo surgery to remove the cancer, followed by a reduced intensity of additional treatments. The study will monitor the participants’ swallowing abilities and overall health over time to assess the impact of the treatment changes.

Throughout the study, researchers will collect information on the participants’ survival rates and any side effects experienced. The goal is to find a balance between effective cancer treatment and minimizing the negative impact on patients’ daily lives, particularly focusing on their ability to swallow and overall well-being. This research could lead to improved treatment protocols for individuals with HPV-positive oropharyngeal cancer in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and readiness for treatment.

Informed consent is required, ensuring understanding of the study’s procedures and requirements.

2 initial assessment

An initial assessment is conducted to evaluate the current health status and suitability for the treatment plan.

This includes a review of medical history and any necessary laboratory tests.

3 surgery

Transoral surgery is performed to remove the tumor from the oropharynx.

Neck dissection may also be conducted as part of the surgical procedure.

4 adjuvant treatment planning

Following surgery, a treatment plan is developed to reduce the intensity of additional therapies while maintaining effectiveness.

The plan aims to improve swallowing function and reduce side effects.

5 chemotherapy administration

Chemotherapy may be administered intravenously using medications such as cisplatin or carboplatin.

The specific dosage and frequency are determined based on individual health status and treatment goals.

6 radiotherapy

Radiotherapy is provided to target any remaining cancer cells and prevent recurrence.

The intensity and duration are adjusted to minimize side effects while ensuring treatment effectiveness.

7 follow-up assessments

Regular follow-up assessments are conducted to monitor overall health, swallowing function, and any side effects.

These assessments include both qualitative and quantitative evaluations of swallowing ability.

8 quality of life evaluation

Quality of life is assessed using specific questionnaires to understand the impact of treatment on daily living.

This includes evaluating both physical and emotional well-being.

9 study completion

The study is expected to conclude by October 2028, with ongoing monitoring and data collection until that time.

Final assessments will determine the overall success of the treatment plan in improving survival and quality of life.

Who Can Join the Study?

Must have a confirmed or suspected type of cancer called squamous cell carcinoma in the oropharynx, which is part of the throat.
Must be able to undergo radiotherapy, a treatment using radiation to kill cancer cells.
Must have a positive test for HPV (Human Papillomavirus) using specific tests called P16 and either High Risk HPV In-Situ Hybridization (ISH) or Polymerase Chain Reaction (PCR).
Must be fit for and able to potentially benefit from a combination of chemotherapy and radiotherapy, as decided by a group of healthcare professionals called a multidisciplinary team (MDT).
Must be willing to receive chemotherapy, a treatment using drugs to kill cancer cells.
Must have enough healthy bone marrow, which is the spongy tissue inside bones, to handle chemotherapy. This is measured by certain blood counts.
Must have a good enough GFR (Glomerular Filtration Rate), which measures kidney function, to receive a specific chemotherapy drug called Cisplatin.
Must have cancer at a specific stage, according to a system called UICC/AJCC TNM, which describes the size and spread of cancer.
Must have a decision from the MDT to treat with surgery that involves removing the tumor through the mouth and possibly removing lymph nodes in the neck.
Must be considered fit for surgery and additional radiotherapy after surgery.
Must be 18 years old or older.
Must provide written informed consent, which means agreeing to participate in the study after understanding all the details. In France, if unable to give written consent, a trusted person can confirm consent in writing.
In France, must be part of a Social Security System.
In France, must be willing and able to follow the study plan, including attending scheduled visits and undergoing tests and procedures.

Who Cannot Join the Study?

Patients who do not have HPV-positive oropharyngeal cancer cannot participate. This type of cancer is found in the throat and is linked to the human papillomavirus (HPV).
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants, but the exact group is not detailed here.
Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent, but the exact group is not specified here.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
Asklepios Klinik St George	Hamburg	Germany
Katholisches Marienkrankenhaus gGmbH	Hamburg	Germany
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Institut Sainte Catherine	Avignon	France
Clinique Saint Vincent	St Denis	France
Ibricsbb Rrgvauvl Dx Ctpqno Dt Mwodmjnbzty	Montpellier	France
Crbnierc Saaypr Cpqznpuv	St Denis	France
Cjyuua Lwlq Bvfrqc	Lyon	France
Ckn Rinujwr spvh sar	Saint Pierre	France
Sklnqnutaxco Kxbsguko Srinnobu gbcrr	Solingen	Germany
Cozqlj Hdgepguufwr Rcoitvdz Uitltqavxrtgn Dx Tskfi	Tours	France
Gnckaz Hlrslfdlhsf Uvmkyhnzsvlwd Phyho Pugoqmwpqpm Ej Npjcsxepdloj	Paris	France
Csv Cifiy Rjsofzbspqq	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.12.2020
Germany	Not recruiting	02.12.2020

Trial locations

Investigated drugs:

Cisplatin is a chemotherapy medication used to treat various types of cancer, including oropharyngeal cancer. In this trial, it is used as part of the adjuvant treatment to help eliminate any remaining cancer cells after surgery.

Radiation Therapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is used as an adjuvant treatment to target any remaining cancer cells following surgery for HPV-positive oropharyngeal cancer.

Investigated diseases:

Oropharyngeal squamous cell carcinoma

Human papillomavirus (HPV)-positive oropharyngeal cancer – This is a type of cancer that occurs in the oropharynx, which is the middle part of the throat, including the back of the tongue, tonsils, and walls of the throat. It is associated with infection by the human papillomavirus (HPV), a common virus that can cause changes in the cells of the oropharynx. The disease often begins with symptoms such as a persistent sore throat, difficulty swallowing, or a lump in the neck. As it progresses, it may lead to more severe swallowing difficulties and changes in voice. The cancer can spread to nearby tissues and lymph nodes, affecting the function of the throat and surrounding areas. Early detection and monitoring are crucial for managing the progression of this disease.

Trial ID:

2024-516673-68-00

Protocol code:

SPON1610-17

NCT ID:

NCT02215265

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Treatment Intensity for Patients with HPV-Positive Oropharyngeal Cancer Using Cisplatin and Carboplatin

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