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Conversion intraperitoneal chemotherapy with oxaliplatin plus drug combination in colorectal cancer with peritoneal metastases unsuitable for upfront surgery or HIPEC

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on colorectal cancer with peritoneal metastases, a condition where cancer that started in the colon or rectum has spread to the lining of the abdomen. Participants will receive chemotherapy that is delivered directly into the abdominal cavity, known as intraperitoneal administration. The chemotherapy regimens being tested include several drugs such as cisplatin, paclitaxel, docetaxel, gemcitabine, oxaliplatin, doxorubicin, mitomycin, and irinotecan. These medicines are given as a solution that is infused into the abdomen.

The purpose of the trial is to compare how well two different intraperitoneal chemotherapy combinations shrink the tumors. After being randomly assigned to one of the two treatment arms, participants will receive three cycles of the assigned chemotherapy, followed by imaging scans to see if the tumors have reduced in size. The study also looks at whether the treatment makes it possible to later have surgery with heated chemotherapy, called HIPEC, if the tumors respond well.

During the study, participants will visit the clinic for each chemotherapy infusion, which is given through a small tube placed in the abdomen. After the three treatment cycles, a special scan will be performed to measure tumor changes, a process referred to as assessing the objective response rate, which simply means checking how much the cancer has shrunk. Safety will be monitored throughout, and participants will continue to be followed for several years to track overall health and any further disease changes.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study enrollment
Upon joining the trial, a personal study identification number is assigned and initial health information is recorded.
Step 2
Randomization
The patient is randomly placed into one of two experimental arms. this process determines which combination of intraperitoneal chemotherapy drugs will be used.
Step 3
First treatment cycle
The assigned intraperitoneal chemotherapy is given. each drug is prepared as a solution for infusion and the dose is calculated per square meter of body‑surface area:
cisplatin: 65 mg/m², paclitaxel: 30 mg/m², docetaxel: 120 mg/m², gemcitabine: 850 mg/m², oxaliplatin: 150 mg/m², doxorubicin hydrochloride: 20 mg/m², mitomycin: 9 mg/m², irinotecan hydrochloride trihydrate: 200 mg/m².
The infusion is performed according to the study protocol.
Step 4
Subsequent treatment cycles
The same set of drugs and doses is repeated for a total of three treatment cycles. each cycle follows the same infusion procedure as the first.
Step 5
Radiological assessment
After the third cycle, imaging studies are performed to evaluate the tumor response. the result is expressed as the objective response rate based on radiological criteria.
Step 6
Evaluation for possible surgery
If the imaging shows sufficient tumor reduction, the patient may be considered for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC). this decision is made by the study’s multidisciplinary team.
Step 7
Safety monitoring
All adverse events are recorded from the day of randomization until three weeks after the last treatment cycle. safety data are reviewed regularly.
Step 8
Long‑term follow‑up
The patient continues to be followed for up to 3.5 years to monitor overall survival and any disease progression.

Who can join the trial?

9 criteria

Provide written informed consent before any study procedures (you must sign a form showing you understand and agree to take part).
Have an ECOG Performance Status score of 0, 1, or 2, or a Karnofsky score between 60 and 100 (these scores measure how well you can perform daily activities).
Show adequate kidney, liver, and bone marrow function on laboratory tests (your organs must be working well enough for treatment).
If you are a woman who could become pregnant, you must have a documented negative pregnancy test (to confirm you are not pregnant).
Be at least 18 years old but younger than 80 years.
Have colorectal cancer located more than 10 cm from the anal opening, with cancer spread to the lining of the abdomen (peritoneal metastases) that can be seen on a CT scan. The spread may be present at the same time as the original tumor (synchronous) or develop later (metachronous), and the original tumor may or may not still be present.
Have a CT‑based Peritoneal Cancer Index (CT‑PCI) greater than 10 (often meaning a surgical PCI greater than 15) as judged by the study board, and be considered a candidate for cytoreductive surgery and HIPEC if the tumor responds well. If the CT‑PCI is less than 10, you may still qualify if you need conversion therapy to become eligible for surgery and HIPEC.
Both cancers with RAS mutations and those without (wild‑type) are allowed (RAS is a gene that can be changed in some tumors).
Must not have received any previous treatment specifically for peritoneal metastatic disease (no prior surgery or chemotherapy aimed at the spread in the abdomen).

Who cannot join the trial?

11 criteria

Having had a serious side‑effect or allergic reaction to any of the chemotherapy drugs used in this study.
Being unable to receive the full dose of chemotherapy because of other health problems (called comorbidities) or lasting side‑effects such as nerve damage (neurotoxicity), or because of a genetic condition called DPYD deficiency that affects drug metabolism.
Having a type of cancer that lacks a normal DNA‑repair system, known as deficient mismatch repair cancer.
Having had major open abdominal surgery such as a full removal of tumor tissue (CRS) or heated chemotherapy delivered inside the abdomen (HIPEC) that caused large scar tissue (called intraperitoneal adhesions). Small keyhole (laparoscopic) procedures are allowed.
Having experienced a severe abdominal infection (abdominal septicemia) or other conditions that could cause a lot of scar tissue inside the abdomen; a short diagnostic procedure (staging laparoscopy) may be used to check for this.
Being pregnant or breastfeeding (lactating).
Having an active infection that needs antibiotics.
Having active liver disease and testing positive for hepatitis B, hepatitis C, or HIV (human immunodeficiency virus), as shown by blood tests (serology).
Receiving any other cancer treatment besides the study medication within four weeks before the study starts or within four weeks after it ends.
Having cancer located in the lower or middle part of the rectum; only tumors higher than 10 cm from the anal opening are allowed.
Needing radiation therapy before surgery (preoperative radiation).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Karolinska University Hospital
Verified
Solna, Sweden
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Verified
Gothenburg, Sweden
Region Skane Skanes Universitetssjukhus
Verified
Lund, Sweden

Trial locations

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Investigated drugs

Cisplatin
is a chemotherapy medicine that damages the DNA of cancer cells, helping to stop them from growing. In this trial it is given directly into the abdominal cavity (intraperitoneally) to treat colorectal cancer that has spread to the lining of the abdomen.
Paclitaxel
is a chemotherapy drug that interferes with the way cancer cells divide, making it harder for them to multiply. In the study it is delivered into the abdomen to target cancer cells that have spread to the peritoneal surface.
Docetaxel
works similarly to paclitaxel by preventing cancer cells from completing their division cycle. It is administered intraperitoneally in this trial to help shrink or control tumors on the abdominal lining.
Gemcitabine
is a chemotherapy agent that blocks the building blocks needed for cancer cells to make new DNA, slowing their growth. In this study it is given directly into the peritoneal cavity to attack colorectal cancer cells that have spread there.
Oxaliplatin
is a chemotherapy drug that forms links in the DNA of cancer cells, making it difficult for them to copy their genetic material. It is used intraperitoneally in the trial to treat cancer that has spread to the abdominal lining.
Doxorubicin
is a chemotherapy medication that interferes with the DNA and the energy production of cancer cells, helping to kill them. In this trial it is given directly into the abdomen to target peritoneal metastases from colorectal cancer.

What is already known about the treatment

Cisplatin
Given as a sterile solution that is poured into the abdominal cavity for intraperitoneal infusion; it is a well‑established cancer drug used worldwide and described in many studies; it is mainly used for colorectal cancer that has spread to the peritoneum as well as other solid tumors; it works by attaching to DNA and causing the strands to stick together, which stops cancer cells from dividing; it belongs to the class of platinum‑based chemotherapy agents.
Paclitaxel
Supplied as a concentrated solution for intraperitoneal infusion into the abdomen; it is an approved chemotherapy with extensive clinical literature; it is used to treat peritoneal spread of colorectal cancer and other cancers; it stabilizes tiny structures called microtubules so that cancer cells cannot separate properly during division; it is classified as a taxane chemotherapy.
Docetaxel
Provided as a solution for intraperitoneal infusion; it is a widely used anticancer medicine with many published trials; it is indicated for colorectal cancer with peritoneal metastases and other solid tumors; it also strengthens microtubules, preventing cancer cells from finishing the division process; it belongs to the taxane family of chemotherapy drugs.
Gemcitabine
Comes as a liquid that is infused into the peritoneal cavity; it is an approved drug with a solid record in medical research; it is used for colorectal cancer that has spread to the peritoneum and for several other cancers; it mimics a building block of DNA, causing the cancer cell’s DNA to break when it tries to copy itself; it is classified as an antimetabolite chemotherapy.
Oxaliplatin
Available as a solution for intraperitoneal infusion; it is a standard chemotherapy agent with a large body of clinical evidence; it treats peritoneal metastases from colorectal cancer and other gastrointestinal cancers; it attaches to DNA and forms cross‑links that block the cancer cell’s ability to grow; it is a platinum‑based chemotherapy drug.
Doxorubicin
Delivered as a sterile solution for intraperitoneal infusion; it is a long‑standing cancer medication with extensive literature; it is used for colorectal cancer with peritoneal spread and many other tumor types; it slips between DNA strands and creates free‑radical damage that kills cancer cells; it belongs to the anthracycline class of chemotherapy.

Investigated diseases

Colorectal cancer with peritoneal metastases - This condition starts when cancer develops in the colon or rectum and then spreads to the lining of the abdominal cavity. Cancer cells detach from the original tumor and travel through the abdominal fluid. They attach to the peritoneal surface and grow into new tumor nodules. As the nodules increase, the abdomen can become enlarged and cause discomfort, changes in bowel habits, or fluid buildup. The disease usually progresses gradually, with more and larger peritoneal tumors appearing over time.