← Back to Search

Chemotherapy

Chemoradiation for Rectal Cancer

Phase < 1

Waitlist Available

Led By Jessica M Frakes, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have the ability to swallow and retain oral medications

Histologically confirmed diagnosis of adenocarcinoma of the rectum

Must not have

Any diagnosis of acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease

BMI > 40 is considered exclusive from this study due to increased surgical complication risk and greater risk of incomplete resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether using MRI to guide chemoradiation therapy can improve response to treatment.

Who is the study for?

This trial is for adults with Stage II or III rectal adenocarcinoma, confirmed by MRI. Participants must be able to take oral meds, have good organ function and blood counts, not be pregnant or breastfeeding, and willing to use birth control. Excluded are those with unresectable cancer, prior invasive rectal malignancy, metastatic disease outside the radiation field, HIV/AIDS, inability to undergo MRI due to medical reasons (except controlled anxiety), major surgery within 12 weeks before enrollment, known DPD deficiency.

What is being tested?

The study tests if MRI-guided adaptive chemoradiation therapy can better treat locally advanced rectal cancer. It involves using Capecitabine pills alongside radiation therapy and possibly adding FOLFOX regimen (a combination of chemotherapy drugs) depending on individual responses.

What are the potential side effects?

Possible side effects include skin irritation from radiation; fatigue; nausea; diarrhea from Capecitabine; low blood cell counts leading to increased infection risk or bleeding problems; liver issues; neuropathy (tingling in hands/feet) from FOLFOX.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can swallow and keep down pills.

Select...

My diagnosis is rectal adenocarcinoma.

Select...

I am fully active or have some restrictions but can still care for myself.

Select...

My rectal cancer is at an early to mid-stage and close to the front of my pelvic area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with HIV/AIDS.

Select...

My BMI is 40 or less.

Select...

My rectal cancer cannot be surgically removed due to its spread.

Select...

My tumor is not causing blockage in my intestines.

Select...

I have not had major surgery in the last 12 weeks.

Select...

I have inflammatory bowel disease or had abdominal surgery affecting my digestion.

Select...

My rectal cancer is not adenocarcinoma but another type.

Select...

I have had radiation therapy to my pelvic area before.

Select...

I am not currently on any experimental treatments.

Select...

I have had rectal cancer before or have a family history of polyposis syndrome.

Select...

I have more than one colorectal cancer at the same time.

Select...

I have seizures that medication does not control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of MRI guided dose adaptive chemoradiation therapy

Secondary study objectives

Number of Participants with Complete Clinical Response (cCR)

Number of Participants with Pathological Complete Response (pCR)

Other study objectives

Number of Participants with Disease-Free Survival (DFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MRI-guided adaptive radiationExperimental Treatment3 Interventions

Patients will receive capecitabine-based chemoradiotherapy (chemotherapy with capecitabine + radiation). Dosing will be modified based on tumor changes measured daily and weekly by MR-guided radiotherapy (MRgRT) utilizing MR-linac (MRL) systems. Chemoradiotherapy will be followed by standard of care consolidated chemotherapy. (FOLFOX)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

Radiation Therapy

2017

Completed Phase 3

~7250