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Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00021398
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Fluorouracil    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1996

Detailed Description:

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.

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021398

Locations
United States, New Jersey
Community Medical Center    
      Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County    
      Mount Holly, New Jersey, United States, 08060
Hunterdon Regional Cancer Center    
      Flemington, New Jersey, United States, 08822
St. Francis Medical Center    
      Trenton, New Jersey, United States, 08629
Riverview Medical Center    
      Red Bank, New Jersey, United States, 07701
Kimball Medical Center    
      Lakewood, New Jersey, United States, 08701
United States, Pennsylvania
Bon Secours-Holy Family Health System    
      Altoona, Pennsylvania, United States, 16602
Conemaugh Memorial Hospital    
      Johnstown, Pennsylvania, United States, 15905
Southern Chester County Medical Center    
      West Grove, Pennsylvania, United States, 19390
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111
North Penn Hospital    
      Lansdale, Pennsylvania, United States, 19446
Paoli Memorial Hospital    
      Paoli, Pennsylvania, United States, 19301-1792
Pinnacle Health Hospitals    
      Harrisburg, Pennsylvania, United States, 17105-8700
Pottstown Memorial Regional Cancer Center    
      Pottstown, Pennsylvania, United States, 19464
Reading Hospital and Medical Center    
      Reading, Pennsylvania, United States, 19612-6052
Saint Mary Regional Center    
      Langhorne, Pennsylvania, United States, 19047
Delaware County Memorial Hospital    
      Drexel Hill, Pennsylvania, United States, 19026

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Benjamin Movsas, MD     Fox Chase Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068776, FCCC-96071, NCI-G01-1988
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00021398
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II rectal cancer  
stage III rectal cancer  
adenocarcinoma of the rectum  

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on October 07, 2008




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