Intraperitoneal Paclitaxel for Stomach Cancer
(STOPGAP II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding paclitaxel, a chemotherapy drug, directly into the abdomen alongside standard chemotherapy can better control gastric cancer and extend patient survival. Participants will be divided into two groups: one will receive only standard chemotherapy, while the other will receive both standard chemotherapy and paclitaxel through a special abdominal port. This approach may benefit those previously treated for gastric or gastroesophageal cancer who do not have cancer in other organs, such as the liver or lungs. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering hope for improved outcomes.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the study team to get guidance based on your specific situation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using paclitaxel directly in the abdominal area for treating stomach cancer yields promising safety results. In one study, paclitaxel was safely administered at doses of 100 mg/m². However, some patients experienced a drop in white blood cells, known as neutropenia, which can increase the risk of infections. This side effect was common with weekly treatments.
Other studies suggest that this method might help patients live longer, which is encouraging. These safety results come from earlier trials, and the current phase of the trial aims to gather more information about the treatment's safety and effectiveness.
For concerns about the safety of this treatment, discussing them with the study team or a doctor is advisable.12345Why are researchers excited about this trial's treatments?
Intraperitoneal paclitaxel is unique because it delivers chemotherapy directly to the abdominal cavity, targeting stomach cancer cells more directly than traditional systemic treatments. Unlike standard chemotherapy options that circulate throughout the body, this method allows for higher concentrations of the drug in the tumor area with potentially fewer side effects. Researchers are excited about this approach because it could enhance treatment effectiveness and improve patient outcomes by concentrating the therapy where it's needed most, potentially leading to better control of the disease.
What evidence suggests that this trial's treatments could be effective for stomach cancer?
Research has shown that delivering paclitaxel directly into the abdomen can extend the lives of patients with stomach cancer. In this trial, participants in one arm will receive systemic therapy combined with intraperitoneal paclitaxel. Studies have found that this method, when used with standard chemotherapy, significantly improves survival rates compared to chemotherapy alone. For instance, one study found that patients who received paclitaxel both inside the abdomen and through a vein experienced much better outcomes. In another study, 78% of patients were still alive after one year, highlighting this approach's potential. These findings suggest that paclitaxel delivered into the abdomen may effectively target cancer cells, possibly leading to longer survival for those with stomach cancer.23678
Who Is on the Research Team?
Maheswari Senthil
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with microsatellite stable gastric or gastroesophageal adenocarcinoma, who've had 3-6 months of first-line treatment without extensive metastases or bowel obstruction. They must be fit (ECOG 0-1), able to undergo laparoscopy, and have no history of surgeries that would interfere with the procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Participants undergo a diagnostic laparoscopy to evaluate gastric cancer and determine study group assignment
Treatment
Participants receive either standard systemic therapy or systemic therapy plus intraperitoneal paclitaxel for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Intraperitoneal Port Placement
- Paclitaxel
Trial Overview
The study tests if adding intraperitoneal paclitaxel to standard chemotherapy improves outcomes in gastric cancer spread to the abdomen. Participants are randomly assigned during diagnostic laparoscopy to either receive standard IV chemotherapy alone or combined with abdominal paclitaxel via a port.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients on Arm B will start systemic therapy + intraperitoneal paclitaxel as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization. Therapy will be administered on Days 1 and 8 of a 21-day cycle for 4 cycles. After 12 weeks (+/- 2 weeks) of study treatment, patients will undergo restaging assessments as outlined in Section 5.2 (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). Patients who are found to have stable disease or a response may continue assigned protocol treatment and will undergo restaging every 12 weeks (+/- 2 weeks) as outlined in Section 5.2. Treatment will continue until progression (radiographic progression or clinical progression as defined in Section 6), intolerance (unacceptable toxicity), or cytoreduction.
Patients on Arm A will start systemic therapy with physician's choice of any standard-of-care systemic regimen for gastric/GEJ adenocarcinoma. Patients on Arm A will start systemic therapy as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization. After 12 weeks (+/- 2 weeks) of standard of care treatment, patients will undergo a restaging assessment as outlined in Section 5.2 (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). Patients who are found to have stable disease or a response may continue assigned standard of care treatment and will undergo restaging every 12 weeks (+/- 2 weeks) as outlined in Section 5.2. Treatment will continue until progression (radiographic progression or clinical progression as defined in Section 6), intolerance (unacceptable toxicity), or cytoreduction.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Intraperitoneal and intravenous paclitaxel plus S-1 versus ...
Conclusions: Intraperitoneal and intravenous paclitaxel plus S-1 significantly improved the overall survival compared to intravenous paclitaxel ...
Phase II Study of Weekly Intravenous and Intraperitoneal ...
The 1-year OS rate was 78% (95% confidence interval 65% to 90%). The overall response rate was 56% in 18 patients with target lesions. Malignant ascites ...
3.
blog-ecog-acrin.org
blog-ecog-acrin.org/now-enrolling-ea2234-stopgap-ii-study-for-patients-with-stomach-cancer-spread-to-the-abdominal-cavity/STOPGAP II Clinical Trial for Stomach Cancer (EA2234)
It may reach more cancer cells and has been shown to improve survival rates in other types of cancer.
Review Article Outcomes of intraperitoneal chemotherapy ...
Findings indicate a significant survival benefit in patients receiving CIPC (HR 0.66 [95%CI, 0.49–0.88], P = 0.0054)(Lu et al., unpublished data). This trial ...
Intraperitoneal paclitaxel for peritoneal metastases from ...
The overall survival from first treatment was not a primary outcome measure, yet was humbling at 10.8 months. Longer term survival was achieved ...
Phase 1 trial of intraperitoneal paclitaxel in patients with ...
Paclitaxel may be safely used at intraperitoneal doses of 100 mg/m 2 . Neutropenia associated with weekly treatments was common.
Study Details | NCT07001748 | Testing the Addition of ...
Can we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in ...
8.
onclive.com
onclive.com/view/nips-boosts-overall-survival-over-ps-in-gastric-cancer-with-peritoneal-metastasisNIPS Boosts Overall Survival Over PS in Gastric Cancer ...
In the phase 3 PHOENIX-GC trial (UMIN000005930), the median survival time was 17.7 months (95% CI, 14.7-21.5) with intraperitoneal paclitaxel ( ...
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