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Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer Clinical research trials and Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer. Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer  Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
For Condition: stage 3 rectal cancer,Quality of Life,adenocarcinoma of the rectum,stage 2 rectal cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer.
Details: OBJECTIVES: I. Determine the local recurrence rate, disease-free survival, and overall survival of patients with stage II or III rectal cancer treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection and adjuvant fluorouracil and leucovorin calcium. II. Determine the toxicity rate in patients treated with this regimen. III. Correlate failure-free survival with ultrasound-determined preoperative staging in patients treated with this regimen. IV. Determine the quality of life of patients treated with this regimen. V. Determine if toxicity due to treatment, daily stool frequency, sexual dysfunction, and disease-free survival correlates with quality of life parameters in patients treated with this regimen. VI. Correlate clinical selection criteria with ability to perform sphincter-sparing surgery in patients treated with this regimen. VII. Determine post-chemoradiotherapy pathological response, margin status, and lymph node status and correlate these factors with initial clinico-pathologic findings in patients treated with this regimen. PROTOCOL OUTLINE: Patients undergo pelvic radiotherapy once daily five days a week for 5 weeks followed by boost radiotherapy twice daily for 7 days. Patients also receive neoadjuvant fluorouracil IV continuously over days 1-4 and 36-40. Patients undergo surgical resection 4-6 weeks after completion of radiotherapy. At 4 weeks after surgery, patients receive adjuvant leucovorin calcium IV and fluorouracil IV once daily five days a week. Treatment continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the completion of pelvic and boost radiotherapy, at 4 weeks after completion of chemoradiotherapy (prior to surgery), and then at 3, 6, and 12 months after completion of study therapy. Patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 23-41 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the rectum; Tumor extending through bowel wall (T3) OR Fixation to surrounding structures (T4) OR Nodal involvement by endorectal ultrasound (N1-2) - Tumor extending through bowel wall but not fixed (T3) must be: At least 4 cm or at least 40% of bowel circumference OR Accompanied by nodal involvement - Evidence of transmural penetration confirmed by 2 of the following: CT scan; Pelvic; MRI; Transrectal ultrasound; Physical exam - Proximal extent of tumor must not extend higher than 12 cm above denate line and must be below pelvic peritoneal reflexion or sacral promontory - Regional lymph node involvement allowed - No distant metastases by CT scan of abdomen and pelvis or chest x-ray --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for rectal cancer - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy for rectal cancer - Surgery: No prior surgery for rectal cancer except diagnostic biopsy --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-1 - Life expectancy: At least 2 years - Hematopoietic: Leukocyte count greater than 4,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 10 g/dL - Hepatic: SGOT and SGPT less than 1.5 times normal; Bilirubin less than 1.5 mg/dL - Renal: Creatinine less than 1.8 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix; No psychiatric condition that would preclude informed consent; No other serious medical illness that would limit survival
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BenjaminMovsas, Study Chair, Fox Chase Cancer Center
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
United States
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Riverview Medical Center
Red Bank, New Jersey, 07701
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Southern Chester County Medical Center
West Grove, Pennsylvania, 19390
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
North Penn Hospital
Lansdale, Pennsylvania, 19446
United States
Additional Information:
Study ID Numbers: CDR0000068776; NCI-G01-1988,FCCC-96071
Study Start Date: August 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021398
Other Stage 2 Rectal Cancer Studies:
1. Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
2. Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
3. Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
4. IM-862 in Treating Patients With AIDS-Related Kaposi's Sarcoma
5. Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
Related Studies:
Other stage 2 rectal cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other West Grove Clinical Trials
Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
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