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

NCT00084591 | Completed Phase 1

• 3 other identifiers: CDR0000365462P30CA006927FCCC-03606
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

• Acute toxicity by CTCAE at 6 weeks following study completion

Secondary Outcomes (1)

• 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

Interventions

capecitabine DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Combined Modality Therapy; Therapeutics

Study Officials

• Gary Freedman, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: December 1, 2003
• Study Completion: February 1, 2007
• Last Updated: February 12, 2010

Record last verified: 2010-02

Locations

US (1)