Completed

Randomized Phase II Trial Of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer

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What is being tested

Radiation Therapy

+ Capecitabine 1200 mg/m^2/day

+ Irinotecan

RadiationDrugProcedure
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 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: * Evaluate the pathologic complete response rate in patients with locally advanced rectal cancer undergoing surgical resection treated with 2 different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy. * Evaluate the time to treatment failure and patterns of failure in patients treated with these regimens. * Evaluate the incidence of hematologic and non-hematologic grade 3-4 toxicity (preoperatively, postoperatively, and overall) in patients treated with these regimens. * Evaluate the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical stage of tumor (T3 vs T4). Patients are randomized to 1 of 2 treatment arms. Quality of life is assessed at baseline, within 1 week after completion of radiotherapy, within 1 week after completion of adjuvant chemotherapy (12 months), and then at 24 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Official TitleRandomized Phase II Trial Of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer 
NCT00081289
Principal SponsorRadiation Therapy Oncology Group
Last updated: January 13, 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

146 patients to be enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesRectal NeoplasmsColorectal Neoplasms

Criteria

Inclusion Criteria: 1. Adenocarcinoma of the rectum originating at or below 12 cm from the anal verge without evidence of distant metastases 2. Patient must be 18 years of age or greater. 3. Potentially resectable en bloc based upon surgeon evaluation 4. Clinical stages T3 or T4, based upon endorectal ultrasound, or physical examination (only acceptable for T4 lesions). 5. Absolute neutrophil count of \> 1500 per microliter and platelet count \> 100,000 per microliter; aspartate aminotransferase (AST) and alkaline phosphatase \< 2.5 X upper limit of normal (ULN), bilirubin \< = 1.5 ULN, calculated creatinine clearance \> 50 ml/min using Cockcroft-Gault formula: * CrCl male = (140 - age) x (wt. in kg) / (Serum Cr) x 72 * CrCl female = 0.85 x (CrCl male) 6. Zubrod performance status 0-2 7. No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix, or ductal carcinoma in situ of the breast. Previous invasive cancer permitted if disease free at least 5 years. 8. Signed study-specific informed consent prior to randomization Exclusion Criteria: 1. Any evidence of distant metastasis 2. Synchronous primary colon carcinomas, except T1 lesions (full colonoscopy not required for enrollment) 3. Extension of malignant disease to the anal canal 4. Prior radiation therapy to the pelvis 5. Prior chemotherapy for malignancies 6. Pregnancy or lactation, (exclusion due to potential adverse effects of therapy). Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered to be of non-childbearing potential.) Patients will agree to continue contraception for 30 days from the date of the last study drug administration. 7. Serious, uncontrolled, concurrent infection(s). 8. Participation in any investigational drug study within 4 weeks preceding the start of study treatment. 9. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. 10. Evidence of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. 11. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation. 12. Major surgery within 4 weeks of the study treatment. 13. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. 14. Known, existing uncontrolled coagulopathy. 15. No concurrent cimetidine allowed.

Study Plan

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

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive neoadjuvant therapy comprising 45 Gy (1.8 Gy/fx) + 5.4 Gy boost (1.8 Gy/fx) radiation therapy (RT), oral capecitabine 1200mg/m\^2/day 5 days/week during RT, and irinotecan 50 mg/m\^2 IV for 1 hour days 1, 8, 22, 29. Surgery 4-8 weeks after RT. Postoperative chemotherapy beginning Day 1 postoperatively for nine 14-day cycles(folinic acid 400 mg/m\^2 over 2 hours Day 1; 5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 plus 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning Day 1; and oxaliplatin 85 mg/m\^2 IV over 2 hours Day 1) .

Group II

Experimental
Patients receive neoadjuvant therapy comprising 45 Gy (1.8 Gy/fx) + 5.4 Gy boost (1.8 Gy/fx) radiation therapy (RT), oral capecitabine 1650mg/m\^2/day 5 days/week during RT, and oxaliplatin 50 mg/m\^2 IV for 2 hours days 1, 8, 15, 22, 29. Surgery 4-8 weeks after RT. Postoperative chemotherapy beginning Day 1 postoperatively for nine 14-day cycles(folinic acid 400 mg/m\^2 over 2 hours Day 1; 5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 plus 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning Day 1; and oxaliplatin 85 mg/m\^2 IV over 2 hours Day 1) .

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 5 locations

Suspended

University of California Davis Cancer Center

Sacramento, United StatesSee the location
Suspended

Baptist-South Miami Regional Cancer Program

Miami, United States
Suspended

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, United States
Suspended

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, United States
Completed5 Study Centers