Trial · NCT07271355
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
NCT07271355, Phase 3, Recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial. Trials, record NCT07271355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07271355
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
- NCT number
- NCT07271355
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 129 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Appendix Carcinoma AJCC v8, Stage IVC Colorectal Cancer AJCC v8, Unresectable Colorectal Carcinoma
- Interventions
Bevacizumab, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Fluorouracil, Irinotecan Hydrochloride, Leucovorin Calcium, Magnetic Resonance Imaging, Mitomycin, Questionnaire Administration
- First posted
- 2025-12-09
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | From randomization to death from any cause, assessed up to 5 years | The primary analysis will follow the intention-to-treat principle. OS will be summarized by the Kaplan-Meier method, and a one-sided stratified log-rank test will be used to compare treatment arms, with hazard ratios and 95 percent confidence intervals (CIs) estimated from Cox proportional hazards models. |
| Secondary | Progression-free survival (PFS) | From randomization to time of progression or death, whichever occurs first, assessed up to 5 years | Progression is as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 via contrast-enhanced computed tomography scan. CIs for the true success proportion will be calculated according to the approach of Clopper and Pearson. |
| Secondary | Win ratio | Up to 5 years | Will be based on OS events being more clinically meaningful than PFS events. |
| Secondary | Objective response rate | Up to 5 years | Will be measured by RECIST 1.1, Peritoneal Regression Grading Score (PRGS), Peritoneal Carcinomatosis Index (PCI) on diagnostic laparoscopy, and biochemical response with serum tumor marker. For RECIST criteria, efficacy can be defined as the percentage of evaluable patients who have achieved complete response (CR), partial response (PR), or stable disease (SD). For PCI, efficacy can be defined as the percentage of evaluable patients who have achieved CR, PR, or SD. For PRGS, efficacy can be defined as the percentage of evaluable patients who have achieved a decrease in average PRGS over successive biopsies. The proportion of successes will be estimated by the number of successes divided by the total number of patients initiating therapy. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson. |
| Secondary | Incidence of post-operative surgical complications | Up to 4 weeks after final pressurized intraperitoneal aerosolized chemotherapy (PIPAC) | Will be measured by Clavien-Dindo classification 4 weeks after each PIPAC. Results will be strictly descriptive in nature. |
| Secondary | Rate of patients who have cytoreductive surgery | Up to 5 years | |
| Secondary | Patient-reported health state/quality of life and symptoms | Week 0 up to 12 months | Will be measured by the European Organisation for the Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ30) and EORTC-Colorectal Cancer (CR29). Patient-reported outcomes will be summarized with descriptive statistics. |
| Secondary | Patient-reported number of good days | At 6 months and 1 year | Patient-reported outcomes will be summarized with descriptive statistics. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07271355
GET https://conductscience.org/api/trials/v1/NCT07271355/registered