Completed

Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer

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What is being tested

Data Collection

Who is being recruted

Digestive System Diseases
+8

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

Treatment Study

Phase 1
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorFox Chase Cancer Center
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the maximum tolerated dose of neoadjuvant boost intensity-modulated radiotherapy when combined with capecitabine before surgery in patients with locally advanced rectal cancer. Secondary * Determine the pathologic tumor response in patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a dose-escalation study of boost intensity-modulated radiotherapy (IMRT). Patients undergo neoadjuvant IMRT with incorporated boost once daily 5 days a week for 5 weeks. Beginning on the first day of radiotherapy, patients receive oral capecitabine twice daily 7 days a week for 5 weeks. Patients undergo surgical resection 4-8 weeks after completion of chemoradiotherapy. Cohorts of 3-6 patients undergo escalating doses of boost IMRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity. Quality of life is assessed at baseline, at week 5 of chemoradiotherapy, before surgery, and then at 1, 3, and 12 months after surgery. Patients are followed at 1, 3, and 12 months after surgery. PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for this study.

Official TitlePhase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer 
NCT00084591
Principal SponsorFox Chase Cancer Center
Last updated: January 18, 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.
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.

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.
Over 18 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 primary adenocarcinoma of the rectum * Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam * Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests: * Physical exam * Transrectal ultrasound * Pelvic CT scan * Pelvic MRI * No clinical evidence of metastatic disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No known, uncontrolled coagulopathy Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT and SGPT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times normal * Creatinine clearance \> 50 mL/min Cardiovascular * No clinically significant cardiac disease * No congestive heart failure * No symptomatic coronary artery disease * No poorly controlled cardiac arrhythmias * No myocardial infarction within the past year Gastrointestinal * No active inflammatory bowel disease * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome Other * No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer * No concurrent serious, uncontrolled infection(s) * No prior unanticipated severe reaction to fluoropyrimidine therapy * No known sensitivity to fluorouracil * No prior uncontrolled seizures * No CNS disorders that would preclude study participation * No other medical or psychiatric condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for rectal cancer Chemotherapy * No prior chemotherapy for rectal cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for rectal cancer * No prior pelvic radiotherapy Surgery * More than 4 weeks since prior major surgery and recovered * No prior surgery for rectal cancer Other * More than 4 weeks since prior participation in another investigational drug study * No concurrent celecoxib


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
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
Fox Chase Cancer CenterPhiladelphia, United StatesSee the location

CompletedOne Study Center
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