Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.


Options:
A: DISEASE CHARACTERISTICS:

* Diagnosis of cancer that supports the use of radiotherapy to the pelvis
* No current or prior metastases beyond pelvic regional lymph nodes
* Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin
* Planned course of pelvic radiotherapy must fall within the following parameters:

  * Pelvis must be encompassed by the planned radiotherapy fields

    * Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints
    * Portions of the rectum may have special blocking, depending upon disease site
  * Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)\*

    * Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned
  * Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis

    * Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day\*
* NOTE: \*For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.
* No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)
* No brachytherapy planned before the completion of all external-beam radiotherapy
* No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* Hemoglobin ≥ 10.0 g/dL
* Leukocytes ≥ 3,500/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)
* Able to complete questionnaires alone or with assistance
* No history of inflammatory bowel disease
* No history of gastrointestinal or genitourinary obstruction or porphyria
* No history of G6PD deficiency
* No history of irritable bowel syndrome
* No history of blood dyscrasia
* No history of severe allergies or asthma
* No history of hepatic or renal disease
* No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week
* No medical condition that may interfere with the ability to receive study treatment
* No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior pelvic radiotherapy
* No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
* No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)
* No other concurrent sulfasalazine
* No concurrent digoxin
B: Inclusion Criteria:

histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of \<15% calculated by the Yale-formula; Risk \[%\] = \[GS -5\] x \[PSA/3 + 1.5 x T\], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

* Karnofsky-Index ≥ 70%
* age between 40 and 80 years
* PSA

Exclusion Criteria:

Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
C: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Clinical stage T1b-T3c disease
  * No clinical or radiographic evidence of metastasis
* Prostate-specific antigen (PSA) less than 80 ng/mL
* Gleason score at least 5
* One of the following criteria must be met:

  * PSA greater than 10 ng/mL
  * Gleason score greater than 6
  * T2b or greater palpable disease
  * Three or more biopsy cores involved with a Gleason score of at least 5

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other medical condition that would preclude study participation
* No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia)
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* No more than 4 months of prior androgen deprivation therapy
* Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only

Radiotherapy

* No prior pelvic radiotherapy

Surgery

* No prior or planned radical prostate surgery
D: Inclusion Criteria:

* They had a pelvic cancer: gynecologic, rectal, or prostatic,they were to receive radiotherapy treatments for a minimum of 40 Gy at the pelvic level , with or without chemotherapy and they had Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1

Exclusion Criteria:

* they had previous radiotherapy treatments in the pelvic or abdominal region, medical history of gastro-intestinal inflammation, malabsorption syndrome or inflammatory bowel disease or coeliac disease, ileostomy, daily use of anti-diarrheal medication before radiotherapy, pregnancy or breastfeeding, neutropenia or probiotics intolerance

Answer: C