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NCT04703101 · ClinicalTrials.gov registry record · Phase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
A Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04703101: Recruiting Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center.
NCT04703101 is a Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8 that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 25 participants, below the 123-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04703101, a Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, 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. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.
Primary Outcome
Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the non-operational management (NOM) and total mesorectal excision (TME) cohorts separately.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- RADIATION Intensity-Modulated Radiation Therapy
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-02-11 |
| Est. Completion | 2027-10-15 |
| Phase | Phase 1 |
What NCT04703101 shows while recruiting
NCT04703101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 123-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (80% lower).
The record links to 10 conditions, with Rectal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT04703101 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04703101 about?
NCT04703101 is a clinical study titled "Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer". This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorourac...
What is the current status of trial NCT04703101?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-02-11. Estimated completion is 2027-10-15.
What conditions does trial NCT04703101 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 NCT04703101?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Intensity-Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04703101?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04703101 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rectal Adenocarcinoma
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 NCT04703101's enrollment target sits among peer trials
25 14th of 17 higher than 4 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.
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