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Chemotherapy

Chemotherapy + Radiation for Rectal Cancer

Phase 2 & 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Diagnosis of rectal adenocarcinoma

ECOG Performance Status (PS): 0, 1 or 2

Must not have

Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)

Any prior pelvic radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether a different combination of chemotherapy drugs (FOLFOX) and selective use of radiation therapy is better than the standard 5FUCMT treatment for locally advanced rectal cancer.

Who is the study for?

This trial is for adults diagnosed with locally advanced rectal cancer who are fit enough for chemotherapy and surgery, have measurable disease, and can undergo a specific surgical technique (TME). They must not have had recent chemo or pelvic radiation, other cancers within 5 years (with some exceptions), or be pregnant. Adequate contraception use is required.

What is being tested?

The study compares standard chemoradiation therapy (5FUCMT) before surgery to FOLFOX chemotherapy alone with selective use of radiation based on the tumor's response. The goal is to see if avoiding radiation can reduce side effects without compromising effectiveness.

What are the potential side effects?

Chemoradiation may cause fatigue, skin changes, bowel issues, and blood count changes. FOLFOX can lead to nerve damage (neuropathy), allergic reactions, diarrhea, low blood counts increasing infection risk, and mouth sores.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with rectal cancer.

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I can take care of myself and perform daily activities.

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My kidney function, measured by creatinine, is within normal limits.

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I have at least four lymph nodes larger than 10 mm.

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My surgeon is qualified or willing to qualify in a specific surgical technique for my treatment.

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My breast cancer is at a specific stage (T2N1, T3N0, T3N1).

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I was 18 or older when I was diagnosed.

Exclusion Criteria

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

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My scans show the tumor is too close to or invading the protective layer around the rectum, making complete surgical removal unlikely.

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I have had radiation therapy to my pelvic area before.

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My surgeon has recommended an APR surgery for me.

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I understand the study drug may affect my DNA and could harm a pregnancy.

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I am of childbearing age and do not plan to use birth control.

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I am currently breastfeeding.

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My cancer is large or has spread to nearby tissues.

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I haven't had chemotherapy in the last 5 years, but hormone therapy is okay.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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

DFS

Pelvic R0 Resection Rate

Secondary study objectives

Local Recurrence (TLR)

Neoadjuvant Rectal Score

Overall Survival

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1Experimental Treatment4 Interventions

Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.

Group II: Group 2Active Control3 Interventions

Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

surgery

2005

Completed Phase 4

~7080

0 / 15Eligibility criteria met