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Anti-metabolites

Chemo-Radiation for Rectal Cancer

Phase 2
Waitlist Available
Led By Erqi L Pollom
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG 0, 1, or 2
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

Study Summary

This trial will test if a combo of chemo and radiation is better than just radiation for treating rectal cancer, and if it is safe and has good quality of life.

Who is the study for?
Adults with rectal cancer that requires surgery, who can sign consent and have no metastases. They must be in good physical condition (ECOG 0-2), not pregnant or breastfeeding, willing to use contraception, and have adequate organ function. Excluded are those with prior treatments for rectal cancer, other active cancers except certain skin cancers/cervical carcinoma in situ, uncontrolled illnesses, known hypersensitivity to treatment drugs, detectable HIV load or on anti-retroviral therapy.Check my eligibility
What is being tested?
The trial tests if a combination of chemotherapy (FOLFOXIRI) and radiotherapy (IMRT) increases the chance of preserving organs in patients with rectal cancer compared to standard treatment. It also assesses the quality of life after this combined treatment approach.See study design
What are the potential side effects?
Possible side effects include reactions related to chemotherapy such as nausea, vomiting, diarrhea; blood cell count changes leading to increased infection risk; fatigue; liver enzyme alterations; and potential radiation-related skin issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I am 18 years old or older.
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My organs and bone marrow are functioning well.
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My rectal cancer is advanced beyond early stages.
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My rectal cancer requires surgery as decided by my medical team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical complete response (cCR)
Secondary outcome measures
Colostomy-free survival
Disease free survival (DFS)
Local regrowth rate
+2 more

Side effects data

From 2021 Phase 2 trial • 27 Patients • NCT01882816
81%
Lymphocyte count decreased
15%
White blood cell decreased
15%
Anemia
15%
Hyperglycemia
15%
Neutrophil count decreased
11%
Stridor
11%
Hypocalcemia
11%
Platelet count decreased
4%
Stoma site infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
IMRT and Doxorubicin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiation/FOLFOXIRIExperimental Treatment4 Interventions
Treatment will comprise 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI. Patients who have performance status or conditions that may preclude use of FOLFOXIRI may be treated with FOLFOX or XELOX. Those who achieve a clinical complete response will be considered for organ preservation approach. All other patients will receive standard of care total mesorectal excision (TME).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMRT
2003
Completed Phase 3
~1570
FOLFOX regimen
2009
Completed Phase 3
~2440
XELOX
2018
Completed Phase 3
~620
FOLFOXIRI
2011
Completed Phase 3
~680

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,373 Previous Clinical Trials
17,327,924 Total Patients Enrolled
Erqi L PollomPrincipal InvestigatorStanford Universiy

Media Library

FOLFOXIRI (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04380337 — Phase 2
Colorectal Cancer Research Study Groups: Radiation/FOLFOXIRI
Colorectal Cancer Clinical Trial 2023: FOLFOXIRI Highlights & Side Effects. Trial Name: NCT04380337 — Phase 2
FOLFOXIRI (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04380337 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please describe the risk factors associated with intensity-modulated radiation therapy?

"As this is a Phase 2 clinical trial, and there are some data points in support of safety but none for efficacy, we at Power have assigned IMRT a score of two."

Answered by AI

How many participants can be accommodated in this experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial is currently recruiting participants, having first been published on May 21st 2020 and most recently updated on January 13th 2022. The research team is seeking 37 people to join the study at one site."

Answered by AI

Are recruitment efforts for this research undertaking still open?

"Correct. Clinicaltrials.gov reveals that this clinical investigation, initially posted on May 21st 2020, is actively searching for participants. This single-site trial intends to enroll 37 individuals in total."

Answered by AI
~8 spots leftby Mar 2025