Study of drug combination therapy for patients with lymph node-positive esophageal and esophagogastric junction cancer using carboplatin, paclitaxel, fluorouracil, folinic acid, docetaxel and oxaliplatin

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What is this study about?

This clinical trial focuses on treating patients with adenocarcinoma of the esophagus and esophagogastric junction. The study aims to evaluate a treatment approach called Total Neoadjuvant Therapy (TNT) in patients whose cancer has spread to nearby lymph nodes but has not spread to other parts of the body.

The treatment involves a combination of several cancer medications administered through intravenous infusion. These medications include fluorouracil, docetaxel, oxaliplatin, carboplatin, paclitaxel, and folinic acid. These drugs work together to kill cancer cells or stop them from growing. The medications will be given in specific sequences and combinations over several weeks.

The study will examine how well patients respond to this treatment by measuring how long they remain free from cancer progression. The treatment plan includes giving these medications before surgery, which is different from traditional approaches where some treatments are given after surgery. This approach aims to potentially improve outcomes for patients with this type of cancer.

1 Initial evaluation

Your treatment will begin with medical tests to confirm your eligibility for the trial. This includes blood tests to check bone marrow, kidney, and liver function.

A heart and lung assessment will be performed if you have any related symptoms.

For patients 70 years or older, a special health assessment will be conducted.

2 Treatment Path Assignment

You will be assigned to receive one of two treatment combinations:

Option 1: FLOT treatment followed by CROSS treatment

Option 2: CROSS treatment followed by FLOT treatment

3 FLOT Treatment

This treatment consists of 4 cycles of medication given through an intravenous infusion

The medications include: fluorouracil, oxaliplatin, and docetaxel

Regular blood tests will monitor your response to treatment

4 CROSS Treatment

This treatment includes 5 cycles of chemotherapy given through an intravenous infusion

The medications used are: carboplatin and paclitaxel

Treatment will be monitored for any side effects

5 Response Evaluation

After completing both treatments, your response will be evaluated through medical imaging

The medical team will assess if the cancer has responded to the treatment

Based on the results, further treatment decisions will be made

6 Follow-up Period

Regular check-ups will continue for 2 years after treatment completion

These visits will include medical examinations and quality of life assessments

Any side effects will continue to be monitored and managed

Who Can Join the Study?

Age 18 or older. For patients aged 70 or above, a special assessment of general health and functioning will be required
Diagnosed with adenocarcinoma (a type of cancer) of the esophagus or where the esophagus meets the stomach, that can be surgically removed
No previous chemotherapy treatment for esophageal cancer
No previous radiation therapy to the chest, abdomen, or neck area that would overlap with the planned treatment area
Good overall physical condition (able to carry out all normal activities with minimal restrictions)
Weight loss must be less than 10% of body weight
Adequate heart and lung function
Healthy blood counts, including:
- White blood cells above 3×109/L
- Hemoglobin above 5.5 mmol/L
- Platelets above 100×109/L
Good kidney function and liver function tests within acceptable ranges
For women who can become pregnant:
- Negative pregnancy test during screening
- Must use effective birth control during the study and for 3 months after
Cancer growth into the stomach area must not exceed 4 cm when measured by endoscopy
Must be able to understand and comply with study procedures
Must provide written informed consent to participate

Who Cannot Join the Study?

Age below 18 years or above 75 years
Previous treatment with chemotherapy or radiation therapy for esophageal cancer or esophagogastric junction cancer
Presence of distant metastases (cancer spread to other parts of the body)
Significant heart conditions, including heart failure or recent heart attack (within last 6 months)
Severe liver disease or abnormal liver function tests
Severe kidney disease or abnormal kidney function tests
Active infections requiring treatment
Other types of cancer in the past 5 years (except adequately treated non-melanoma skin cancer)
Pregnancy or breastfeeding
Mental conditions that could interfere with following study procedures
Known allergies to study medications
Participation in other clinical trials within the past 30 days
Unable to swallow oral medications
Peripheral neuropathy (nerve damage causing numbness or tingling in hands and feet) grade 2 or higher
Inability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Holland Protonen Therapie Centrum	Delft	The Netherlands
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Lmtsx Uostvagvqbme Meuzonn Coprvny (bpaev	Leiden	The Netherlands
Zpzywfqj Rdmovizuyuejhiizzt Ilvwfgwpi	Vlissingen	The Netherlands
Riafcqedhnrnvotzah Awuymg	Arnhem	The Netherlands
Ryqdofdoiiwnszxdpy Iwonmxmhr Frclkwuco	Leeuwarden	The Netherlands
Acbsrlftf Uye	Amsterdam	The Netherlands
Euvwhci Uniakajywegu Mcuuhpg Czmjvah Ransgzgnj (xpenahz Mdq	Rotterdam	The Netherlands
Sgh Edhvyvqyh Huelbccx Tzfdcqn	Tilburg	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.07.2025

Trial locations

Investigated drugs:

FLOT is a combination chemotherapy treatment that includes fluorouracil, leucovorin, oxaliplatin, and docetaxel. This treatment is used to fight esophageal cancer and cancer at the junction between the esophagus and stomach.

CROSS is a combined treatment approach that includes chemotherapy with carboplatin and paclitaxel along with radiation therapy. This treatment is designed to shrink tumors in the esophagus and surrounding areas before surgery.

Note: Both treatments are used as neoadjuvant therapy, which means they are given before the main cancer surgery to help shrink the tumor and improve surgical outcomes.

Esophageal Cancer – A disease that develops in the tissues of the esophagus, the muscular tube that connects the throat to the stomach. It typically begins in the cells that line the inside of the esophagus. The disease can develop gradually, starting with changes in the esophageal cells. As it progresses, it can affect the deeper layers of the esophageal wall.

Esophagogastric Junction Cancer – A cancer that forms at the area where the esophagus meets the stomach. This type of cancer develops in the cells at this specific junction point. The disease affects the lower portion of the esophagus and the upper portion of the stomach. It can spread through the layers of tissue at the junction area as it progresses.

Trial ID:

2025-521158-40-00

Protocol code:

TNT-OES-2

NCT ID:

NCT06161818

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of drug combination therapy for patients with lymph node-positive esophageal and esophagogastric junction cancer using carboplatin, paclitaxel, fluorouracil, folinic acid, docetaxel and oxaliplatin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?