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Study of Cisplatin, Carboplatin and Durvalumab Treatment for Patients with Intermediate and High-Risk Oropharyngeal Cancer

3 1 1 1

What is this study about?

This clinical trial focuses on oropharyngeal cancer, which is a type of cancer that affects the middle part of the throat, including the base of the tongue and tonsils. The study aims to compare different treatment approaches to improve survival rates in patients with intermediate and high-risk forms of this disease.

The treatment combines several medications given through intravenous infusion. These include cisplatin and carboplatin, which are chemotherapy drugs that help fight cancer cells, along with durvalumab, which is a type of medication that helps the body’s immune system detect and fight cancer cells. These medications will be given together with radiation therapy, which uses high-energy rays to target cancer cells.

The study will monitor how well patients respond to the treatment combinations by tracking their overall health, quality of life, and ability to swallow. The treatment schedule includes regular visits to receive the medications and check-ups to monitor the patient’s progress. Throughout the study, doctors will carefully watch for and manage any side effects that may occur from the treatment.

1 Initial evaluation

Your eligibility will be confirmed through medical tests including blood work to check kidney function, liver function, and blood cell counts

A physical examination will be performed to assess your overall health status and ECOG performance status (a measure of your ability to perform daily activities)

2 Treatment assignment

You will be assigned to one of the treatment groups for oropharyngeal cancer (cancer affecting the throat area)

Your specific treatment plan will be determined based on your cancer characteristics and risk factors

3 Treatment administration

You will receive a combination of treatments that may include:

Chemotherapy medications (cisplatin or carboplatin) given through an intravenous line

Durvalumab (an immunotherapy medication) given through an intravenous line

Radiotherapy will be administered alongside these medications

4 Monitoring during treatment

Regular assessments will track any side effects using standardized criteria

Blood tests will continue to monitor your kidney function, liver function, and blood counts

Your ability to swallow will be evaluated using specific assessment tools

5 Follow-up assessments

Quality of life assessments using questionnaires at specified intervals

Evaluation of swallowing function at 24 months after treatment starts

Regular check-ups to monitor your recovery and cancer status

Assessment of any late side effects up to 2 years after treatment

Who Can Join the Study?

  • Age between 18 and 70 years
  • Diagnosed with oropharyngeal squamous cell carcinoma (cancer in the throat area, specifically in the base of tongue, tonsil, or uvula)
  • Must be recommended for treatment with combined chemotherapy and radiation therapy by a team of medical specialists
  • No other cancers in the past 5 years (except for non-melanoma skin cancer and certain cervical conditions)
  • Body weight more than 30 kg
  • Good overall physical condition (able to carry out all normal activities)
  • Expected survival of at least 3 months
  • Normal kidney function
  • Healthy blood cell counts
  • Normal liver function
  • Normal blood clotting function
  • For women who can become pregnant: must have either confirmation of post-menopausal status or a negative pregnancy test
  • Must provide written informed consent to participate in the trial
  • Must be willing to follow the study protocol, including attending all scheduled visits and examinations

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Previous chemotherapy (drug treatment) for head and neck cancer
  • Previous radiotherapy (radiation treatment) to the head and neck area
  • Previous surgery for oropharyngeal cancer
  • Presence of distant metastases (cancer spread to other parts of body)
  • Inability to give informed consent
  • Pregnancy or breastfeeding
  • Active serious infection including HIV (human immunodeficiency virus)
  • Serious heart or lung conditions that could interfere with treatment
  • Other active cancers in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Mental health conditions that could affect participation in the study
  • Drug or alcohol dependency
  • Participation in other clinical trials within 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
St James’s Centre at St Luke’s Radiation Oncology Network Dublin Ireland
University Hospital Galway Galway Ireland
Saint Luke’s Radiation Oncology Network Dublin Ireland

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

Trial status

Country Status Recruitment Start
Ireland Ireland
Not recruiting
31.01.2025

Trial locations

Investigated drugs:

Based on the provided trial data, this appears to be a comparative study of treatment regimens for oropharyngeal cancer, but specific medications are not listed in the source data. Without explicit information about the medications or therapies involved, I cannot provide a detailed list of treatments and their descriptions.

The trial appears to focus on comparing different treatment approaches for intermediate and high-risk oropharyngeal cancer, with an emphasis on survival outcomes, quality of life, toxicity, and swallowing function, but the specific interventions are not detailed in the provided data.

If you would like me to list and describe the medications involved in this trial, please provide additional data containing information about the specific treatments being studied.

Oropharyngeal Cancer – A cancer that develops in the oropharynx, which is the middle part of the throat behind the mouth, including the base of the tongue, tonsils, and surrounding tissues. The disease typically begins in the squamous cells that line the throat and can spread to nearby lymph nodes. It may cause difficulty swallowing, persistent sore throat, and changes in voice quality. The condition can affect speech and swallowing functions as it progresses. Oropharyngeal cancer may develop gradually, often starting with changes in the cells of the throat tissue.

Trial ID:
2024-516108-41-00
Protocol code:
RG_14-093
NCT ID:
NCT04116047
Trial Phase:
Therapeutic confirmatory (Phase III)

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