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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

Must not have

Ongoing or active infections requiring treatment

Prior pelvic RT or chemotherapy for rectal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I am currently being treated for an infection.

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I have had radiation or chemotherapy for rectal cancer before.

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My rectal cancer is at a stage where surgery can save the sphincter.

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My rectal cancer cannot be removed with surgery.

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I do not have any other cancer types except for the allowed exceptions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

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

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

Primary study objectives

Clinical complete response (cCR)

Secondary study objectives

Colostomy-free survival

Disease free survival (DFS)

Local regrowth rate

+2 more

Side effects data

From 2022 Phase 2 & 3 trial • 101 Patients • NCT01554397

91%

Grade 3 or higher neutropenia

45%

Grade 3 or higher hematologic toxicity

33%

Clinically significant GI toxicity

31%

Grade 2 GI toxicity

Grade 3 or higher GI toxicity

100%

80%

60%

40%

20%

Study treatment Arm

IMRT

PET-Guided Bone Marrow-Sparing IMRT

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: 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

FOLFOXIRI

2011

Completed Phase 3

~680

XELOX

2018

Completed Phase 3

~620