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Anti-metabolites

Combination Chemotherapy + Radiation for Rectal Cancer

Phase 1

Recruiting

Led By Ann Raldow

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2

Histologically confirmed rectal adenocarcinoma

Must not have

Active treatment of a separate malignancy

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well radiation therapy and chemotherapy work together to treat rectal cancer.

Who is the study for?

This trial is for adults with stage II-III rectal adenocarcinoma confirmed by lab tests, without metastatic disease. They should be in good enough health to perform daily activities (KPS >= 70 or ECOG 0-2) and have normal blood counts and liver function tests. Pregnant or breastfeeding individuals, those with other active cancers, prior radiation in the same area, or conditions preventing MRI are excluded.

What is being tested?

The study is testing if a short course of high-energy x-ray radiation followed by chemotherapy drugs like leucovorin, fluorouracil, oxaliplatin, and capecitabine can shrink tumors in rectal cancer patients without immediate surgery. The goal is to see if this approach improves quality of life by delaying or avoiding surgery.

What are the potential side effects?

Possible side effects include skin irritation from radiation; nausea, vomiting, diarrhea from chemotherapy; increased risk of infection due to low blood cell counts; fatigue; and potential liver enzyme elevation.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself and am up more than 50% of my waking hours.

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My cancer is a type of rectal cancer confirmed by tissue analysis.

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My cancer can be surgically removed.

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My cancer has not spread to other parts of my body.

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My cancer is at stage II or III according to MRI results.

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 another type of cancer.

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I've had radiation in the same area where my current cancer is located.

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

Complete clinical response rate

Secondary study objectives

Anorectal function

Health-related quality of life

Incidence of adverse events

+4 more

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: Treatment (IMRT, mFOLFOX6, CapeOX, TME)Experimental Treatment8 Interventions

Patients undergo SCRT in the form of IMRT over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin IV and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine PO BID on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surveillance

2010

Completed Phase 3

~2330

Total Mesorectal Excision

2016

Completed Phase 3

~250