Study of Chemoradiation with Carboplatin and Paclitaxel for Elderly Patients with Esophageal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for esophagus cancer in elderly patients. The study involves the use of two medications, carboplatin and paclitaxel, along with radiation therapy. The purpose of the study is to determine the best dose of these treatments that can be safely given to patients and to evaluate how effective they are in treating the cancer.

Participants in the study will receive the treatments through an intravenous method, which means the medications are given directly into a vein. The study is divided into two phases. In the first phase, different doses of the medications and radiation therapy will be tested to find the maximum dose that patients can tolerate. In the second phase, the effectiveness of the recommended dose will be assessed by checking the response of the cancer to the treatment after 12 weeks.

The study aims to find out if the combination of carboplatin, paclitaxel, and radiation therapy can lead to a complete response in the tumor, meaning the cancer is no longer detectable. The study will also monitor for any side effects and evaluate the overall health and quality of life of the participants during and after the treatment. The goal is to improve treatment options for elderly patients with esophagus cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The study focuses on evaluating the effectiveness of a combination of chemotherapy and radiation therapy in elderly patients with esophagus cancer.

2 phase I treatment

The patient will receive two medications: carboplatin and paclitaxel. These medications are administered through an intravenous infusion.

The goal of this phase is to determine the maximum dose that can be tolerated without severe side effects. The doses of carboplatin and paclitaxel will vary, with carboplatin at a maximum dose of AUC 2 and paclitaxel at a maximum dose of 50 mg/m².

Radiation therapy will also be administered, with total doses ranging from 41.4 to 50.4 Gy.

3 amended phase I treatment

In this amended phase, the focus is on two specific radiation doses: 45 Gy and 50.4 Gy, combined with 100% of the maximum doses of carboplatin and paclitaxel.

The purpose is to further refine the treatment regimen for the next phase.

4 phase II treatment

The patient will continue to receive the recommended doses determined in phase I.

The effectiveness of the treatment will be evaluated 12 weeks after the completion of therapy. This evaluation will include imaging tests and endoscopy to assess the tumor’s response.

5 evaluation and follow-up

Throughout the trial, the patient’s health and response to treatment will be closely monitored.

The primary focus is on avoiding severe esophagitis and infections during and after treatment.

Secondary evaluations will include treatment adherence, acute side effects, quality of life assessments, and survival rates.

Who Can Join the Study?

Age must be 75 years or older.
Respiratory function: Must have a breathing test result (VEMS) of 1 liter per second or more.
Must have or have had a basal cell carcinoma, a type of skin cancer.
Geriatric criteria:
- GDS 15 score less than 7 out of 15 (a test for depression).
- MMSE (Folstein) score more than 23 out of 30 (a test for memory and thinking).
- Must have at least one caregiver or helper.
- Walking speed more than 0.8 meters per second without falling in the last 3 months.
- Charlson score 2 or less if over 80 years old, and 3 or less if aged 75 to 80 years.
Must have a sufficient calorie intake of 1000 calories per square meter per day, either by mouth or through a feeding tube.
Must have esophageal cancer, either squamous cell or adenocarcinoma, confirmed by a lab test.
Cancer stage must be T1T2T3, N0-1, M0-M1a according to the TNM classification (a system to describe the size and spread of cancer).
Must be inoperable, meaning surgery is not an option.
Must be able to receive treatment as an outpatient, meaning you do not need to stay in the hospital overnight.
Must have a history of non-metastatic cancer that was treated and has been in remission for more than 5 years.
Blood test requirements:
- PNN (a type of white blood cell) more than 1.5 G/L.
- Platelets more than 100 G/L.
- AST and ALT (liver enzymes) no more than 2.5 times the normal level.
- PAL (another liver enzyme) no more than 2.5 times the normal level.
- Total bilirubin (a liver function test) no more than 1.5 times the normal level.
- Creatinine (a kidney function test) no more than 120 µmol/L with a creatinine clearance of 60 ml/min or more (a measure of kidney function).

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of another type of cancer, except for certain skin cancers, are excluded.
Patients with severe heart problems, such as heart failure, are not eligible.
Those with uncontrolled infections are not allowed to join the study.
Individuals who have had a major surgery within the last 4 weeks are excluded.
Patients with known allergies to the study drugs cannot participate.
People with a history of severe allergic reactions to similar medications are not eligible.
Individuals with significant liver or kidney problems are excluded.
Patients who have received another investigational drug within the last 4 weeks cannot join.
Those with a history of drug or alcohol abuse are not eligible.
Individuals with any other medical condition that the study doctors believe would make participation unsafe are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bygifgph Uyrydvwoqm Huxwfciw Cebzpr	Besançon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	16.11.2016

Trial locations

Investigated drugs:

Carboplatin is a chemotherapy medication used in this trial to treat esophagus cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. The trial aims to find the maximum dose that patients can tolerate and the recommended dose for further treatment phases.

Paclitaxel is another chemotherapy drug used in combination with carboplatin in this study. It helps stop the growth of cancer cells by inhibiting their ability to divide. The trial is testing different dose levels to determine the most effective and tolerable dose for patients.

Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, radiotherapy is combined with chemotherapy to enhance the treatment’s effectiveness. The study is exploring various total doses of radiotherapy to find the optimal level that can be safely administered to patients.

Investigated diseases:

Oesophageal carcinoma

Esophageal Cancer – Esophageal cancer is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby structures. As the cancer progresses, it may cause symptoms such as difficulty swallowing, weight loss, and chest pain. The disease can spread to other parts of the body, including lymph nodes and distant organs. The progression of esophageal cancer can vary, with some types growing more quickly than others. Early detection is crucial for managing the disease effectively.

Trial ID:

2024-514998-21-00

Protocol code:

N/2014/68

NCT ID:

NCT02735057

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Chemoradiation with Carboplatin and Paclitaxel for Elderly Patients with Esophageal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?