Please select the eligibility criteria that correspond to the clinical trial below.
Title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Brief Summary: RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.


Options:
A: Inclusion Criteria:

* Surgery for colon cancer (including rectosigmoid) with histological grade Duke stages A, B or C.
* Completion of postsurgical chemotherapy (Dukes stage C patients).
* Informed consent.

Exclusion Criteria:

* Patients with rectal cancer defined as cancer within 15 cm from anus.
* A poor health status or operative complications making it natural to perform follow up by specialists.
* Additional cancer diagnoses.
* Disseminated cancer.
* Poor mental status.
B: Inclusion Criteria:

* Patients with a removed colorectal adenocarcinoma since less than 6 months, in total remission and for whom a monitoring is necessary to detect recurrences precociously.
* Patients with a removed colorectal tumour which is histologically proved and classified N+ and/or M+ (stage III or IV). Hepatic and/or pulmonary metastasis would have been totally removed since less 6 months before inclusion.
* Patients with a T4N0M0 tumour and operated in emergency (because of a tumoral perforation) can be included. (suppressed by amendment 1)
* 2 before criteria have been replaced by : Patients with colorectal adenocarcinoma which is histologically proved and classified stage II perforated, III or IV, totally removed, in total remission,
* if no metastatic, removed surgery must have been done since less 6 months;
* if metastatic, all metastasis would have been removed, the last surgery dating less 6 months.(amendment 1)
* Casual extension check-up would have been realized before initial surgery or during a period of 6 months after surgery performed in emergency.
* informed consent signed
* Age ≥ 18 years
* Patient in ability to undergone hepatic or pulmonary resection in case of recurrence during the follow-up (ECOG ≤ 2)
* Willingness to control visits

Exclusion Criteria:

* pregnant or breast feeding women, or with a reproductive potential and no practicing an effective method of contraception during the second part of ovarian cycle ( PET is realised during the first part of ovarian cycle)
* Cancer stage I or II (except T4 operated in emergency) or IV without possibility to remove metastasis or R2 after surgery.
* Performance status contraindicating a hepatic or pulmonary surgery in case of recurrence.
* Patients likely to undergone chemotherapy, surgery or radiotherapy during 2 weeks before PET-TDM.
* Other progressive tumoral affection known, or colorectal cancer in progression.

  • (Bad compliance to the study procedure.)(suppressed by amendment 1)
* Not balanced diabetes. (added by amendment 1)
* Patients included in others clinical trials of imagery.
* Inability to provide informed consent signed.
* No social assurance.
C: Inclusion Criteria:

* Radical surgery (R0-resection) for colorectal adenocarcinoma - with or without adjuvant treatment
* Age \< 75 years
* Provision of written informed consent for participation
* "Clean colon" verified by perioperative barium enema or colonoscopy last 3 months post-surgery
* Tumour stage: II-III (Tany N1-2 M0, T3-4NanyM0, Dukes´ B - C)

Exclusion Criteria:

* A clinical diagnosis of HNPCC (non hereditary polyposis colorectal cancer) or FAP (familial polyposis coli)
* Local resection for colorectal cancer (e.g., TEM-procedure)
* Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis)
* Inability to provide informed consent or refusal to do so
* Inability to comply with the control or intense follow-up program
* Participation in other clinical trials interfering with the control-programs
* Previous malignancies (except for non-melanoma skin cancer)
D: DISEASE CHARACTERISTICS:

* Pathologically confirmed adenocarcinoma of the colon or rectum

  * Stage II or III disease
  * No distant metastatic disease
* Has undergone curative resection for no residual tumor
* Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No inflammatory bowel disease
* No other malignancy within the past 5 years except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix
* No genetic syndromes

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Answer: D