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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DFS

Pelvic R0 Resection Rate

Secondary outcome measures

Local Recurrence (TLR)

Neoadjuvant Rectal Score

Overall Survival

+2 more

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

~6010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupNETWORK

124 Previous Clinical Trials

66,259 Total Patients Enrolled

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

216,444 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,931,959 Total Patients Enrolled

Media Library

FOLFOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01515787 — Phase 2 & 3

Colorectal Cancer Research Study Groups: Group 1, Group 2

Colorectal Cancer Clinical Trial 2023: FOLFOX Highlights & Side Effects. Trial Name: NCT01515787 — Phase 2 & 3

FOLFOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01515787 — Phase 2 & 3

Frequently Asked Questions

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

How many different sites are administering this clinical trial?

"For your convenience, this clinical trial is running at 100 different sites. If you choose to participate in the study, try to select a clinic that is near you to reduce travel time and demands."

Answered by AI

Are patients being actively recruited for this clinical trial right now?

"This particular clinical trial, as indicated by the website clinicaltrials.gov, is not currently looking for patients to participate. Although this specific study is not recruiting right now, there are 928 other trials that are actively searching for participants."

Answered by AI