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NCT03594630 · ClinicalTrials.gov registry record · Early Phase 1
Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
A Early Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03594630: Recruiting Early Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03594630 is a Early Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 120 participants, roughly in line with the 117-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594630, a Early Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. 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. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.
Primary Outcome
The study will estimate overall organ preservation rate at 12 months and the corresponding 95% confidence interval (95% CI). The exact confidence interval will be computed when observed number of events is limited. The 12-month organ preservation rate corresponds to the proportion of patients alive and not having surgery within 12 months. The study will use Kaplan-Meier methods to estimate probability of overall organ preservation at 12 months at 12 months for all patients and for deferral patie
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- DRUG Chemotherapy
- OTHER Patient Observation
- PROCEDURE Resection of Rectum
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2026-10-31 |
| Phase | Early Phase 1 |
What NCT03594630 shows while recruiting
NCT03594630 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 117-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target.
The record links to 9 conditions, with Rectal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT03594630 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03594630 about?
NCT03594630 is a clinical study titled "Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer". This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in d...
What is the current status of trial NCT03594630?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 120 participants. The study started on 2024-03-13. Estimated completion is 2026-10-31.
What conditions does trial NCT03594630 study?
This clinical trial studies the following conditions: Rectal Adenocarcinoma, Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8.
What interventions are being tested in trial NCT03594630?
The interventions under investigation include: Questionnaire Administration (OTHER), Chemotherapy (DRUG), Patient Observation (OTHER), Resection of Rectum (PROCEDURE).
Who is sponsoring clinical trial NCT03594630?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03594630 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03594630's enrollment target sits among peer trials
120 4th of 17 higher than 14 of 17 other Rectal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Adenocarcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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