Please select the eligibility criteria that correspond to the clinical trial below.
Title: FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed resectable adenocarcinoma of the rectum

  * Any grade
  * Tumor macroscopically within 15 cm of anal margin on rigid rectoscopy
  * Tumor tethered or partially fixed on digital rectal exam and/or T3-4 on rectal ultrasound
* No acute or subacute bowel obstruction without colostomy diversion
* No chronic inflammatory disease of the ileum and/or colon
* No primary adenocarcinoma of the anal canal
* No distant metastasis

PATIENT CHARACTERISTICS:

Age:

* 80 and under

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count greater than 2,000/mm\^3
* Platelet count greater than 130,000/mm\^3

Hepatic:

* Not specified

Renal:

* Creatinine less than 1.36 mg/dL

Cardiovascular:

* No angina pectoris

Other:

* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the uterine cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic therapy for adenocarcinoma of the rectum

Chemotherapy

* No prior chemotherapy for adenocarcinoma of the rectum

Endocrine therapy

* No prior endocrine therapy for adenocarcinoma of the rectum

Radiotherapy

* No prior radiotherapy for adenocarcinoma of the rectum

Surgery

* No prior surgery for adenocarcinoma of the rectum
B: Inclusion Criteria:

* Adult patients, \>=18 years of age
* Metastatic colorectal cancer and disease progression
* Previously treated with first-line chemotherapy plus Avastin
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2.

Exclusion Criteria:

* Diagnosis of progression of disease more than 3 months after last Avastin administration
* First-line patients with progression-free survival in first-line of \<3 months
* Patients receiving less than 3 consecutive months of Avastin in first-line therapy
* Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
* Clinically significant cardiovascular disease within 6 months prior to start of study treatment
* Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
C: Inclusion Criteria:

* Histologically documented colorectal adenocarcinoma
* Age over 18 years old
* Performance status (ECOG scale): 0-2
* Measurable or evaluable disease
* Patients can take food and drugs orally
* Adequate organ functions
* Life expectancy ≥ 3 months
* Patients should sign a written informed consent before study entry

Exclusion Criteria:

* Tumor type other than adenocarcinoma
* Second primary malignancy
* Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer
* Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
* Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization.
* Presence of CNS metastasis
* Obvious peritoneal seeding or bowel obstruction disturbing oral intake
* Symptomatic peripheral neuropathy
* Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. The patient received curative operation or RFA for metastatic disease.
* Serious illness or medical conditions
* Receiving a concomitant treatment with drugs interacting with S-1, capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent phenytoin warfarin etc.
* Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
* Pregnant or lactating woman
* Women of child bearing potential not using a contraceptive method
* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
* Any patients judged by the investigator to be unfit to participate in the study
D: Participants who met the following main selection criteria were included in the study.

Inclusion Criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Metastatic disease that is not amenable to potentially curative treatment
* One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
* Prior treatment with bevacizumab is permitted.

Exclusion Criteria:

* Prior therapy with irinotecan
* Eastern Cooperative Oncology Group performance status \>2

The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Answer: A