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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00021398
First received: July 11, 2001
Last updated: August 30, 2013
Last verified: August 2013
  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
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Frequency of toxicity [ Designated as safety issue: Yes ]
  • tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy [ Time Frame: during radiation therapy and chemotherapy ]

Enrollment: 23
Study Start Date: July 1996
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Therapy, Chemotherapy and Surgery Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy

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 dentate 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00021398     History of Changes
Other Study ID Numbers: CDR0000068776, P30CA006927, FCCC-96071, NCI-G01-1988
Study First Received: July 11, 2001
Last Updated: August 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Fluorouracil
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on July 31, 2014