Completed

A Pilot Clinical Trial of Preoperative Cetuximab With Concurrent Continuous Infusion Fluorouracil and Pelvic Radiation in Patients With Local-Regionally Advanced Rectal Cancer

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What is being tested

cetuximab

+ fluorouracil
+ neoadjuvant therapy
Biological
Drug
Procedure
Radiation
Who is being recruted

Digestive System Diseases
+8

+ Digestive System Neoplasms
+ Gastrointestinal Diseases
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the safety profile of neoadjuvant cetuximab, fluorouracil, and pelvic irradiation in patients with locally advanced or locally recurrent rectal cancer. Secondary * Determine the activity of this regimen, in terms of pathological complete response rate, in these patients. OUTLINE: This is a non-randomized, open-label, pilot study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64 and fluorouracil IV continuously on days 1-42. Patients undergo whole-pelvic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Treatment continues in the absence of disease progression or unacceptable toxicity. Approximately 1-3 weeks after completion of study treatment, patients undergo surgical resection followed by adjuvant chemotherapy off-study. Patients are followed for up to 5 years.

Official TitleA Pilot Clinical Trial of Preoperative Cetuximab With Concurrent Continuous Infusion Fluorouracil and Pelvic Radiation in Patients With Local-Regionally Advanced Rectal Cancer 
NCT00084773
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
28 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms
Colorectal Neoplasms
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed rectal adenocarcinoma meeting 1 of the following staging criteria: * Locally advanced disease * Resectable (uT3) disease * Primary gross transmural tumor that is not adherent to adjacent pelvic structures by endorectal ultrasound * Primary tethered or unresectable (cT4 or uT4) disease * Primary tumor is contiguous with or adherent or fixed to adjacent pelvic structures by clinical exam and CT scan * Primary surgery would likely leave residual tumor * Small volume extrapelvic metastases allowed * Recurrent disease after definitive resection * Disease limited to the pelvis * Requires combined modality treatment * Epidermal growth factor receptor status-positive, -negative, or -unknown * If previously treated with adjuvant fluorouracil-based chemotherapy, no disease recurrence during or within 12 months after completion of adjuvant therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0 -1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin \> 8.0 g/dL * Platelet count \> 150,000/mm\^3 Hepatic * Not specified Renal * Creatinine ≤ 1.5 times upper limit of normal Cardiovascular * No myocardial infarction within the past 6 months * No evidence of uncontrolled congestive heart failure requiring therapy Other * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No known severe hypersensitivity to cetuximab or any of its excipients * No uncontrolled infection * No high-grade bowel obstruction (bowel lumen ≤ 1 cm) unless patient has undergone protective surgical diversion or endoscopic stenting procedure * No other concurrent medical or psychiatric condition or disease that would preclude study participation * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * No prior cetuximab * No prior murine or chimeric monoclonal antibody therapy * No prior biological response modifiers for metastatic colorectal cancer * No concurrent anti-vascular endothelial growth factor/Flk-1 monoclonal antibody therapy * No other concurrent antibody therapy or immunotherapy * No concurrent gene therapy * No concurrent vaccine therapy * No concurrent angiogenesis inhibitors, including thalidomide Chemotherapy * See Disease Characteristics * No prior chemotherapy for metastatic colorectal cancer * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy Radiotherapy * No prior radiotherapy for metastatic colorectal cancer * No prior pelvic radiotherapy * No other concurrent radiotherapy Surgery * See Disease Characteristics * Fully recovered from prior oncologic or other major surgery Other * No other prior therapy that targets the epidermal growth factor receptor pathway * No other concurrent experimental therapy or drugs * No concurrent matrix metalloprotease inhibitors * No concurrent participation in another clinical study


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64 and fluorouracil IV continuously on days 1-42. Patients undergo whole-pelvic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Treatment continues in the absence of disease progression or unacceptable toxicity. Approximately 1-3 weeks after completion of study treatment, patients undergo surgical resection followed by adjuvant chemotherapy off-study. Patients are followed for up to 5 years.

Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center
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