Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
Brief Summary: COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.


Options:
A: Inclusion Criteria:

1. Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the EUS.
2. Preoperative staging by EUS and pelvic MRI of T2 or T3 superficial, N0. In case of disparity, the higher staging is considered as the definitive diagnosis.
3. Tumours equal to or less than 4 cm of diameter maximum measured using colonoscopy, EUS or MRI. We use the highest score on both scores.
4. ASA score III or less.
5. Absence of distance metastasis as shown on abdominal CT.

Exclusion Criteria:

1. Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N1.
2. Presence of distance metastasis.
3. Synchrony with other colorectal adenocarcinomas.
4. Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
5. Patients with intolerance of preoperative chemotherapy or radiotherapy.
6. Refusal to sign informed consent to enter the study.
B: Inclusion Criteria:

* solitary rectal cancer observed at colonoscopy or on barium X-ray
* no evidence of distant metastases
* distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
* suitable for elective surgical resection
* informed consent

Exclusion Criteria:

* T1 tumors treated by locl excision
* T4 tumors
* patients under 18 years of age
* signs of acute intestinal obstruction
* more than one colorectal tumor
* Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
* active crohn's or active ulcerative colitis
* scheduled need for other synchronous colon surgery
* preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
* preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
* other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III)
* pregnancy
C: * Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =\< 2
* Patient must have histologically confirmed invasive adenocarcinoma of the rectum; Note: patients with rectal tumors suspicious for invasion also are eligible
* Distal border of the patient's tumor must be within 8 cm from the anal verge as measured on endoscopic exam
* Patients with tumors fixed to adjacent structures on digital exam are NOT eligible
* Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4 tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm
* Patients with positive perirectal nodes on ERUS examination are NOT eligible
* Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are NOT eligible
* Patients with the following conditions are NOT allowed on study:

  * Metastatic disease or other primaries (patient must have had chest X-ray/computed tomography \[CT\] and abdominal \& pelvic CT/MRI with IV contrast, as well as a colonoscopy)
  * Previously documented history of familial adenomatous polyposis
  * Previously documented history of hereditary non-polyposis colorectal cancer diagnosed clinically (Amsterdam II criteria) or by genetic testing
  * History of inflammatory bowel disease
  * History of prior radiation treatments to pelvis
  * Clinically significant peripheral sensory or motor neuropathy (defined as symptomatic weakness, paresthesia or sensory alteration described to be interfering with function, interfering with activities of daily living, disabling or life-threatening)
  * History of any clinically significant cardiac disease (i.e., class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, and/or myocardial infarction within the last 6 months)
  * History of uncontrolled seizures or clinically significant central nervous system disorders
  * History of psychiatric conditions or diminished mental capacity that could compromise the giving of informed consent, or interfere with study compliance
  * History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin
  * History of difficulty or inability to take or absorb oral medications
* White blood cells (WBC) \>= 3000/mm\^3
* Absolute neutrophil count (ANC) \> 1,500/mm\^3
* Hemoglobin \> 9.5 mg/dl
* Platelet count \>= 100,000/mm\^3
* Total bilirubin =\< 3 mg/dl
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.0 times institutional upper limit of normal (ULN)
* Alkaline phosphatase =\< 2.0 times ULN
* Creatinine clearance (CLcr) \>= 50 ml/min by Cockroft-Gault equation
* Patients who have experienced a prior malignancy must have received potentially curative therapy for that malignancy, and must be cancer-free for at least five years from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin carcinoma, or in-situ carcinomas)
* Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects; all female participants of childbearing potential must have a negative urine or serum pregnancy test within two weeks prior to study registration
D: Inclusion criteria:

1. Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer without carcinoma in the resection plane.
2. Patients with carcinoma in the resection plane or in case of unreliable resection planes (EMR/ESD) no macroscopic residual tumour confirmed by endoscopy are eligible for randomisation.
3. Only lesions for which TME surgery is indicated can be included (if a partial mesorectal excision (PME) is indicated the patient should be excluded).
4. Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3, lymphatic and/or venous invasion.
5. Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate differentiated and without lymphatic or venous invasion.
6. Complete colonoscopy, without synchronous colorectal cancer.
7. cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging done within 6 weeks before randomisation.
8. Adequate distant staging (X-thorax or CT-thorax and CT-abdomen) without signs of distant metastasis (cM0).
9. Male or female, Age \> 18 years.
10. Life expectancy of at least 12 months.
11. Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
12. No contraindications to chemotherapy, including adequate blood counts;

    * white blood count \>= 4.0 x 10 9/l
    * platelet count \>=100 x 109/l
    * clinical acceptable haemoglobin levels
    * bilirubin \< 35 umol/l
    * creatinine levels indicating renal clearance of \>=50 ml/min
13. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
14. Written (signed and dated) informed consent and be capable of co-operating with protocol.

Exclusion Criteria:

1. Incomplete or inconclusive resection margin with macroscopic residual tumour.
2. T1 tumour with carcinoma \< 3 cm, moderate/well differentiated, without sm3, venous or lymphatic invasion.
3. T1 tumour with carcinoma of \>5 cm and T2 tumour with carcinoma of \> 3 cm.
4. Presence of metastatic disease or recurrent rectal tumour.
5. Previous pelvic radiation.
6. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
7. Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
8. Pregnancy, breast-feeding or fertile women without active birth control.
9. Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (\<6 months prior to randomization), myocardial infarction (\<6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
10. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
11. History of severe and unexpected reactions to fluoropyrimidine therapy.
12. Hypersensitivity to capecitabine.
13. Patients with severe hepatic impairment.
14. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
15. Patients known with dihydropyrimidine dehydrogenase deficiency
16. Any contra-indications to undergo MRI imaging.

Answer: B