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Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
capecitabine
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center

Outcomes

Primary Outcome Measures

Acute toxicity by CTCAE at 6 weeks following study completion

Secondary Outcome Measures

Quality of life as assessed by Quality of Life Questionnaire Core 30 Items (QLQ-C30) before and after radiotherapy and then every 6 months after surgery

Full Information

First Posted
June 10, 2004
Last Updated
February 11, 2010
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00084591
Brief Title
Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer
Official Title
Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy together with chemotherapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase I trial is studying the side effects and best dose of neoadjuvant intensity-modulated radiation therapy with incorporated boost when given together with capecitabine in treating patients with locally advanced rectal cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Acute toxicity by CTCAE at 6 weeks following study completion
Secondary Outcome Measure Information:
Title
Quality of life as assessed by Quality of Life Questionnaire Core 30 Items (QLQ-C30) before and after radiotherapy and then every 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Freedman, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer

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