- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00021398
Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
New Jersey
-
Flemington, New Jersey, Förenta staterna, 08822
- Hunterdon Regional Cancer Center
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Lakewood, New Jersey, Förenta staterna, 08701
- Kimball Medical Center
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Mount Holly, New Jersey, Förenta staterna, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
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Red Bank, New Jersey, Förenta staterna, 07701
- Riverview Medical Center
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Toms River, New Jersey, Förenta staterna, 08755
- Community Medical Center
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Trenton, New Jersey, Förenta staterna, 08629
- St. Francis Medical Center
-
-
Pennsylvania
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Altoona, Pennsylvania, Förenta staterna, 16602
- Bon Secours-Holy Family Health System
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Drexel Hill, Pennsylvania, Förenta staterna, 19026
- Delaware County Memorial Hospital
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Harrisburg, Pennsylvania, Förenta staterna, 17105-8700
- Pinnacle Health Hospitals
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Johnstown, Pennsylvania, Förenta staterna, 15905
- Conemaugh Memorial Hospital
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Langhorne, Pennsylvania, Förenta staterna, 19047
- Saint Mary Regional Center
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Lansdale, Pennsylvania, Förenta staterna, 19446
- North Penn Hospital
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Paoli, Pennsylvania, Förenta staterna, 19301-1792
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
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Pottstown, Pennsylvania, Förenta staterna, 19464
- Pottstown Memorial Regional Cancer Center
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Reading, Pennsylvania, Förenta staterna, 19612-6052
- Reading Hospital and Medical Center
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West Grove, Pennsylvania, Förenta staterna, 19390
- Southern Chester County Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Radiation Therapy, Chemotherapy and Surgery
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Frequency of toxicity
Tidsram: weekly during treatment
|
weekly during treatment
|
tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy
Tidsram: during radiation therapy and chemotherapy
|
during radiation therapy and chemotherapy
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolorektala neoplasmer
- Rektal neoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Skyddsmedel
- Mikronäringsämnen
- Vitaminer
- Kalciumreglerande hormoner och medel
- Motgift
- Vitamin B-komplex
- Fluorouracil
- Leucovorin
- Kalcium
- Levoleucovorin
Andra studie-ID-nummer
- CDR0000068776
- P30CA006927 (U.S.S. NIH-anslag/kontrakt)
- FCCC-96071
- NCI-G01-1988
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