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Chemotherapy

Chemoradiation and Surgery vs Non-Operative Management for Rectal Cancer

Phase 2

Waitlist Available

Led By Julio Garcia Aguilar, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI

Rectal tumor at baseline which would be considered to require complete TME

Must not have

Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.

Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en block resection will not achieve negative margins.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different treatments for locally advanced rectal cancer to see which one results in better 3-year disease-free survival rates.

Who is the study for?

This trial is for adults with locally advanced rectal cancer who haven't had previous treatments like chemotherapy, surgery, or pelvic radiation. They should be generally healthy without active infections and no history of certain cancers in the past 5 years. Women must not be pregnant and agree to use contraception.

What is being tested?

The study tests if a complete treatment before surgery (TNT) followed by either total mesorectal excision (TME) or non-operative management (NOM) improves disease-free survival over standard chemoradiation therapy plus TME and additional chemotherapy.

What are the potential side effects?

Possible side effects include those from radiotherapy such as skin irritation, fatigue, digestive issues; chemotherapy can cause nausea, low blood counts leading to infection risk, nerve damage from Oxaliplatin; endoscopy may result in discomfort or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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

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My rectal cancer needs a total mesorectal excision.

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My diagnosis is rectal adenocarcinoma.

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

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I have not had chemotherapy or surgery for rectal cancer.

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I am at least 18 years old, or 19 if living in certain Canadian provinces.

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I can take care of myself and am up and about more than half of my waking hours.

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I have not had radiation therapy to my pelvic area.

Exclusion Criteria

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

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I am not currently on any other cancer treatments or experimental drugs.

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

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I have had radiation therapy to my pelvic area before.

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I have had a heart attack, stroke, or severe chest pain in the last 6 months.

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I am not pregnant or breast-feeding.

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My rectal cancer has come back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Disease

Secondary study objectives

major adverse events

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

Group I: INCTExperimental Treatment7 Interventions

Arm 1 will receive chemotherapy before chemoradiation. This is called induction neoadjuvant chemotherapy arm (INCT). The neoadjuvant chemotherapy regimen is prescribed specifically as 8 cycles of FOLFOX or 5 cycles of CapeOX over a period of approximately 15-16 weeks. Endoscopic exam (2-4 wks) after chemotherapy. If stable or response then pt will have radiation with either 5-FU or capecitabine.

Group II: CNCTExperimental Treatment7 Interventions

Arm 2 will receive chemoradiation before chemotherapy This is called the consolidation neoadjuvant chemotherapy arm (CNCT). Pt will have 6 weeks of chemoradiation therapy. Along with the radiation the pt will receive either 5-FU or capecitabine. 2-4 weeks after pt will have endoscopic exam and if stable or response pt will have will have 8 cycles of FOLFOX or 6 cycles of CapeOX.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin

2005

Completed Phase 4

~6010

Quality of Life Questionnaires

2005

Completed Phase 4

~1380