S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum (NCT00070434) | Clinical Trial Compass
WithdrawnPhase 2
S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum
Stopped: poor accrual
0Started 2004-08
Plain-language summary
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: This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed primary adenocarcinoma of the rectum
* Locally advanced disease (clinical T3-4, 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 \< 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 ≥ 3,500/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT or SGPT ≤ 2.5 times ULN
* Alkaline phosphatase…
What they're measuring
1
Response (confirmed and unconfirmed response, complete response, partial response)