Study on Treating Stomach Cancer with Peritoneal Spread Using Docetaxel and Oxaliplatin in Patients with Limited Peritoneal Carcinomatosis

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What is this study about?

This clinical trial is focused on treating patients with stomach cancer that has spread to the lining of the abdomen, a condition known as peritoneal dissemination. The study will explore the effectiveness of a treatment approach that combines surgery to remove cancerous tissue, known as cytoreductive surgery, with a special type of chemotherapy called hyperthermic intraperitoneal chemotherapy (HIPEC). This chemotherapy involves heating the chemotherapy drugs and delivering them directly into the abdominal cavity to target cancer cells more effectively.

The trial will compare this new treatment method to the current standard treatment, which is systemic palliative chemotherapy. Two chemotherapy drugs will be used in the study: docetaxel, marketed as TAXOTERE, and oxaliplatin, marketed as Oxaliplatine Accord. These drugs are administered as a solution for infusion, meaning they are given directly into the bloodstream through a vein.

The main goal of the study is to see if the new treatment method can improve the overall survival of patients compared to the standard treatment. Participants will undergo the treatment and be monitored for their response to the therapy, any side effects, and their quality of life. The study will also look at how the drugs are processed in the body and their ability to penetrate cancerous tissues. The trial is expected to continue until December 2025.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current health status.

A biopsy is required to confirm the presence of primary adenocarcinoma or undifferentiated carcinoma of the stomach. Tumors at the junction of the esophagus and stomach are included if the majority of the tumor is in the stomach.

A physical examination and laboratory tests are performed to ensure adequate bone marrow, liver, and kidney function.

2 pre-treatment evaluation

A pre-treatment evaluation is conducted to assess the extent of peritoneal carcinomatosis, which is the spread of cancer within the abdominal cavity. This is confirmed through laparoscopy or laparotomy.

The evaluation also includes a review of previous systemic chemotherapy treatments to ensure there has been no disease progression.

3 surgical intervention

Eligible patients undergo a surgical procedure called gastrectomy, which involves the removal of part or all of the stomach.

Cytoreductive surgery is performed to remove visible tumors within the abdominal cavity.

4 hyperthermic intraperitoneal chemotherapy (HIPEC)

Following surgery, hyperthermic intraperitoneal chemotherapy (HIPEC) is administered. This involves the direct application of heated chemotherapy drugs into the abdominal cavity.

The drugs used are docetaxel and oxaliplatin, both administered as a solution for infusion.

5 post-treatment monitoring

After the HIPEC procedure, patients are monitored for treatment-related toxicity and overall health status.

Regular follow-up visits are scheduled to assess progression-free survival and overall survival.

6 study completion

The study is estimated to conclude by December 1, 2025.

Final assessments will be conducted to evaluate the primary endpoint of overall survival and secondary endpoints such as quality of life and treatment-related costs.

Who Can Join the Study?

Must be 18 years or older.
Must have signed informed consent, which means you agree to participate after understanding the study.
Must have a biopsy-proven primary adenocarcinoma (a type of cancer) of the stomach. This includes tumors at the junction of the esophagus and stomach, as long as most of the tumor is in the stomach and the planned surgery is to remove part of the stomach, not the esophagus.
Must have a cT3-cT4 tumor, which is a classification indicating the size and extent of the tumor, and it should be considered removable by surgery.
Must have limited peritoneal carcinomatosis (cancer spread in the abdominal lining) with a PCI score less than 7, or tumor-positive peritoneal cytology (cancer cells found in the abdominal fluid), confirmed by a procedure called laparoscopy or laparotomy and proven by a lab test.
Must have been treated with systemic chemotherapy, with the last treatment ending within 8 weeks before joining the study.
Must not have any disease progression during the chemotherapy treatment before joining the study.
Must have a WHO performance status of 0-2, which means you are fully active or have some limitations but can still take care of yourself.
Must have adequate bone marrow, liver, and kidney function. This includes specific blood test results:
- White blood cell count greater than 3.0 x 10⁹/L
- Platelet count of at least 100 x 10⁹/L
- Serum bilirubin (a liver function test) less than or equal to 1.5 times the upper limit of normal (ULN)
- ALAT and ASAT (liver enzymes) less than or equal to 2.5 times the ULN
- Creatinine clearance (a kidney function test) of at least 50 ml/min
For female patients who are not sterilized or in menopause:
- Must have a negative pregnancy test.
- Must not be breastfeeding or planning to become pregnant.
- Must use reliable contraceptive methods.

Who Cannot Join the Study?

Patients who have other serious health conditions that could interfere with the study.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the medications used in the study.
Patients who have a history of other types of cancer that could affect the study results.
Patients who have infections that are not well controlled.
Patients who have had major surgery recently.
Patients who have certain heart conditions that could pose a risk during the study.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Oulu University Hospital	Oulu	Finland
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Ziekenhuis St Jansdal	Harderwijk	The Netherlands
Ikazia Ziekenhuis	Rotterdam	The Netherlands
Elisabeth-Tweesteden Ziekenhuis	Tilburg	The Netherlands
Flevoziekenhuis Stichting	Almere	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Umqxnwquzwnq Mluhqlg Cmhtjpd Gkumeshwn	Groningen	The Netherlands
Svkveck	Geldrop	The Netherlands
Aqkimvvvd Uyr	Amsterdam	The Netherlands
Urllvjq Ugcufiuvbw Hfhrzmen	Uppsala	Sweden
Epjvqbb Uouvnolbcilo Mkxnoah Ctzulmw Ronrjxfmr (vgwqpou Msv	Rotterdam	The Netherlands
Abkbud Uggalwtjck Hbcpbdqr	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	14.07.2017
Finland	Not recruiting	14.07.2017
Sweden	Not recruiting	14.07.2017
The Netherlands	Not recruiting	14.07.2017

Trial locations

Investigated drugs:

Cytoreductive Surgery is a procedure aimed at removing as much of the cancerous tissue as possible from the peritoneal cavity. This surgery is used to reduce the number of cancer cells and improve the effectiveness of other treatments.

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a treatment that involves heating chemotherapy drugs and delivering them directly into the abdominal cavity. This method allows for higher concentrations of the drug to be in contact with the cancer cells, potentially increasing the effectiveness of the treatment.

Systemic Palliative Chemotherapy is a treatment that uses drugs to kill cancer cells throughout the body. It is considered the standard treatment for patients with advanced gastric cancer and is used to relieve symptoms and improve quality of life.

Investigated diseases:

Gastric cancer

Peritoneal Carcinomatosis in Gastric Cancer – This condition occurs when cancer cells from the stomach spread to the lining of the abdominal cavity, known as the peritoneum. It is a form of metastasis that can happen in advanced stages of gastric cancer. The spread of cancer cells to the peritoneum can lead to the formation of multiple small tumors on the peritoneal surface. This can cause symptoms such as abdominal pain, bloating, and changes in bowel habits. The progression of the disease can vary, with some patients experiencing a gradual increase in symptoms. The condition is often associated with a more complex disease course due to the involvement of the abdominal cavity.

Trial ID:

2023-510159-53-01

Protocol code:

NL56123.031.15

NCT ID:

NCT03348150

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Treating Stomach Cancer with Peritoneal Spread Using Docetaxel and Oxaliplatin in Patients with Limited Peritoneal Carcinomatosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?