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Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum Clinical research trials and Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum. Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum clinical trial. Subjects typically recieve the finest healthcare available for their Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum  Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum
Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum
For Condition: adenocarcinoma of the rectum,stage 2 rectal cancer,stage 3 rectal cancer
Status: Not yet recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and oxaliplatin, 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. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of induction chemotherapy followed by chemoradiotherapy in treating patients who have locally advancedadenocarcinoma of the rectum.
Details: OBJECTIVES: - Determine the feasibility of obtaining a pre-treatment determination of intratumoral molecular markers (TS, DPD, and ERCC-1) for use in selection of the appropriate regimen for induction cytotoxic combination chemotherapy in patients with cT4 rectal adenocarcinoma. - Determine the response rate (unconfirmed, complete and partial) in patients treated with targeted induction cytotoxic chemotherapy. - Determine the toxicity of targeted induction cytotoxic chemotherapy and chemoradiotherapy in these patients. OUTLINE: This is a multicenter study. - Patients are assigned to 1 of 3 treatment groups based on molecular analysis of the pretreatment tumor specimen. - Group I (lower likelihood of resistance to a fluorouracil-based regimen): Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. - Group II (higher likelihood of resistance to a fluorouracil-based regimen): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on day 1. - Group III (high likelihood of sensitivity to oxaliplatin and fluorouracil therapy): Patients receive oxaliplatin IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Treatment in all groups repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are evaluated for response approximately 2 weeks after the completion of induction chemotherapy. Patients with stable disease or better receive chemoradiotherapy. - Chemoradiotherapy: Beginning approximately 3 weeks after the completion of induction chemotherapy, patients receive oral capecitabine twice daily continuously for 5 weeks and concurrent radiotherapy once daily 5 days a week for 5 weeks. After chemoradiotherapy, patients may undergo attempted surgical resection at the discretion of the treating physician. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 10-65 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary adenocarcinoma of the rectum - Locally advanced disease (clinical T4, N0-2, M0) based on at least 1 of the following criteria: - Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall and/or sacrum - Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane is considered evidence of fixation - Hydronephrosis on CT scan or intravenous pyelogram of ureteric or bladder invasion by cystoscopy and cytology or biopsy - Invasion into the prostate, vagina, or uterus - Transmural penetration of tumor through the muscularis propria as evidenced by CT scan or MRI and endorectal ultrasound - Distal border of the tumor must be at or below the peritoneal reflection (within 12 cm of the anal verge) by proctoscopic examination - Measurable disease by x-ray, scans, or physical examination - Available tumor tissue to determine molecular profile of the tumor before study treatment - No clinical evidence of high-grade (lumen diameter less than 1 cm) large bowel obstruction unless a diverting colostomy has been performed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - See Disease Characteristics - Measured creatinine clearance no greater than 1.5 times ULN OR - Estimated creatinine clearance greater than 50 mL/min Gastrointestinal - See Disease Characteristics - Able to swallow oral medication - No active inflammatory bowel disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other serious medical illness that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for colon or rectal cancer Endocrine therapy - Not specified Radiotherapy - No prior pelvic radiotherapy - No prior intra-operative radiotherapy or brachytherapy - No concurrent intra-operative radiotherapy or brachytherapy - No concurrent intensity-modulated radiotherapy Surgery - See Diseaase Characteristics - See Radiotherapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesAbbruzzese, , M.D. Anderson Cancer Center
Additional Information:
Study ID Numbers: CDR0000334469; SWOG-S0304
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070434
Other Adenocarcinoma Of The Rectum Studies:
1. Combination Chemotherapy in Treating Patients With Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
3. Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum
4. SU011248 in Treating Patients With Metastatic Colorectal Adenocarcinoma (Cancer) That Has Not Responded to Previous Treatment With Irinotecan, Oxaliplatin, and a Fluoropyrimidine With or Without Bevacizumab
5. ZD 1839 in Treating Patients With Recurrent Metastatic Colorectal Cancer
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Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum
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