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NCT03599752 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy and/or Metastasectomy in Treating Patients With Metastatic Colorectal Adenocarcinoma With Lung Metastases
A Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Colorectal Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 6
- Study locations
NCT03599752: Active Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Colorectal Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03599752 is a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Colorectal Adenocarcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (63% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03599752, a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Colorectal Adenocarcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase II trial studies how well chemotherapy and/or metastasectomy work in treating patients with colorectal adenocarcinoma that has spread to the lungs (metastases). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metastasectomy is a surgical procedure that removes tumors formed from cells that have spread from other places in the body. It is not yet known if chemotherapy and metastasectomy together works better in treating patients with metastatic colorectal adenocarcinoma with lung metastases.
Primary Outcome
The primary objective for the low risk group is to evaluate the efficacy of chemotherapy plus surgical resection versus surgical resection alone measured by recurrence-free survival (RFS). The event includes recurrence and death due to any cause. Patients will be stratified at randomization according to three variables: age (age \>= 60 years vs age \< 60 years), RAS mutation status (mutant vs wild type), and location of primary tumor within colon/rectum (right/cecum/ascending colon/hepatic flexu
Conditions Studied
Interventions
- DRUG Chemotherapy
- PROCEDURE Metastasectomy
Study Locations (6)
Texas
- Baylor Colllege of Medicine - Houston
- M D Anderson Cancer Center - Houston
Missouri
- Washington University School of Medicine - St Louis
Pennsylvania
- Thomas Jefferson University - Philadelphia
Ontario
- University Health Network Princess Margaret Cancer Center P2C - Toronto
Quebec
- University of Montreal - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-07-02 |
| Est. Completion | 2030-01-31 |
| Phase | Phase 2 |
What the registry record for NCT03599752 still lists
NCT03599752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (63% lower).
The record links to 6 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Chemotherapy is the first listed.
NCT03599752 lists 6 locations in 5 states (Texas, Missouri, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT03599752 about?
NCT03599752 is a clinical study titled "Chemotherapy and/or Metastasectomy in Treating Patients With Metastatic Colorectal Adenocarcinoma With Lung Metastases". This phase II trial studies how well chemotherapy and/or metastasectomy work in treating patients with colorectal adenocarcinoma that has spread to the lungs (metastases). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping th...
What is the current status of trial NCT03599752?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-07-02. Estimated completion is 2030-01-31.
What conditions does trial NCT03599752 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Colorectal Adenocarcinoma, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT03599752?
The interventions under investigation include: Chemotherapy (DRUG), Metastasectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03599752?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03599752 being conducted?
This trial has 6 study locations across Missouri, Pennsylvania, Texas, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Colorectal Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03599752's enrollment target sits among peer trials
40 9th of 22 higher than 14 of 22 other Stage IV Colorectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Colorectal Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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