|
Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer Clinical research trials and Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer. Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer  Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer
Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer
For Condition: stage 2 rectal cancer,Anemia,stage 3 rectal cancer,adenocarcinoma of the rectum
Status: Not yet recruiting
Sponsor(s): National Surgical Adjuvant Breast and Bowel Project (NSABP) , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as capecitabine and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and reduce the need for blood transfusions. It is not yet known whether combining chemotherapy, radiation therapy, and surgery is more effective with or without epoetin alfa in treating resectablerectal cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combining chemotherapy, radiation therapy, and surgery with or without epoetin alfa in treating patients who have resectable rectal cancer.
Details: OBJECTIVES: - Compare the rate of local-regional relapse in patients with resectable rectal cancer treated with preoperative capecitabine and radiotherapy vs fluorouracil and radiotherapy. - Compare the number of preoperative and intraoperative packed red blood cell transfusion requirements in patients treated with vs without epoetin alfa. - Compare preoperative fatigue and quality of life (QOL) of patients treated with vs without epoetin alfa. - Compare the toxic effects of these regimens in these patients. - Determine the impact of the type of surgical management on QOL at 1 year postoperatively in these patients. - Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens. - Compare the burden of care in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, gender, clinical tumor stage (stage II vs stage III), and surgical intent (sphincter saving vs non-sphincter saving). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive fluorouracil IV continuously on days 1-7 and undergo radiotherapy once daily 5 days a week. Treatment continues for 5-6 weeks. - Arm II: Patients receive oral capecitabine twice daily on days 1-7 and undergo radiotherapy once daily 5 days a week. Treatment continues for 5-6 weeks. In both arms, patients are further randomized to receive no epoetin alfa or epoetin alfa subcutaneously once weekly beginning 7-10 days before initiation of chemoradiotherapy and continuing until the completion of chemoradiotherapy. All patients undergo surgery no more than 8 weeks after completion of chemoradiotherapy. Quality of life is assessed at baseline, after completion of chemoradiotherapy, and at 1 year after surgery. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,606 patients (803 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive adenocarcinoma of the rectum - Diagnosis by incisional (surgical or endoscopic) biopsy within the past 35 days - Stage II (N0 defined as less than 0.5 cm) or III (N1 or 2 defined as at least 0.5 cm) disease - Clinically staged by endoluminal ultrasound and CT scan or MRI - Measurable disease - At least 1 unidimensionally measurable lesion at least 10 mm by conventional techniques (including rigid sigmoidoscope and rectal endoluminal ultrasound) OR at least 10 mm with 5 mm cuts by spiral CT scan - Tumor palpable by clinical rectal exam OR accessible by proctoscope or sigmoidoscope - Distal border of tumor must be located less than 12 cm from the anal verge on endoscopy - Tumor amenable to curative resection - No tumors fixed to surrounding structures that would preclude curative resection even with pelvic exenteration - Enlarged perirectal or pelvic lymph nodes allowed provided surgical removal is not precluded - No synchronous primary rectal lesions - No prior colon or rectal malignancy, regardless of disease-free interval - No multiple primary tumors involving both the rectum and colon - No evidence of distant metastasis - Liver nodule or retroperitoneal adenopathy allowed provided there is no malignancy by tissue documentation - Obstruction allowed provided the only prior treatment was a diverting colostomy PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-2 Life expectancy - At least 10 years (excluding diagnosis of cancer) Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 (unless due to an ethnic or racial variation, as determined by the investigator) - Platelet count at least 100,000/mm^3* NOTE: *Significant underlying hematologic disorders must be excluded if platelet count is not within normal limits Hepatic - Bilirubin no greater than upper limit of normal (ULN) - Alkaline phosphatase less than 2.5 times ULN* - AST less than 1.5 times ULN* - No hepatic disease that would preclude study treatment or follow-up NOTE: *Alkaline phosphatase and AST cannot both be greater than the ULN Renal - Creatinine clearance at least 30 mL/min* - No renal disease that would preclude study treatment or follow-up NOTE: *For patients 70 years of age and older or patients under 70 years of age with a creatinine greater than ULN Cardiovascular - No cardiovascular disease that would preclude study treatment or follow-up - No New York Heart Association class III or IV heart disease - No active ischemic heart disease - No myocardial infarction within the past 6 months - No symptomatic arrhythmia - No uncontrolled hypertension Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, surgically treated carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast - No other nonmalignant systemic disease that would preclude study therapy or follow-up - No active inflammatory bowel disease - No known hypersensitivity to fluorouracil - No known hypersensitivity to mammalian cell-derived products or human albumin - No psychiatric or addictive disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent investigational or antineoplastic biological response modifiers Chemotherapy - No prior chemotherapy for rectal cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for rectal cancer Surgery - See Disease Characteristics - No prior surgery for rectal cancer - Prior preliminary diverting colostomy or stent placement allowed - Prior diagnostic laparoscopy or laparotomy without resection of the primary tumor (other than biopsy) allowed Other - No prior systemic therapy for rectal cancer - No other concurrent investigational drugs or antineoplastic agents - No concurrent halogenated antiviral agents (e.g., sorivudine or brivudine)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertBeart, Study Chair, University of Southern California
Additional Information:
Study ID Numbers: CDR0000298755; NSABP-R-04
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058474
Other Stage 3 Rectal Cancer Studies:
1. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
2. Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
3. Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer
4. Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
5. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
Related Studies:
Other stage 3 rectal cancer Clinical Trials
Other Clinical Trials
Other Clinical Trials
Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer
|
|
|
|
|
|
|
|
