Please select the eligibility criteria that correspond to the clinical trial below.
Title: COLOFOL - A Pragmatic Study to Assess the Frequency of Surveillance Tests After Curative Resection in Patients With Stage II and III Colorectal Cancer - a Randomised Multicentre Trial
Brief Summary: The aim is to conduct a prospective multicentre randomised study comparing two different control regimens after resection for colorectal cancer stage II - III. Follow-up after surgery for colorectal cancer is a controversial issue. The reasons for follow-up are: to obtain a better overall survival, for scientific purposes and/or for psychological reasons and/or as quality assessment. Meta-analyses of randomised controlled studies have lately shown that a beneficial effect on the overall mortality could be found with intense follow-up compared to sporadic. This study compares the regimen of CT-scan or MR scan of the liver, control of the carcinoembryonic antigen (CEA), and CT-scan or X-ray of the lungs in two groups with either control after 12 and 36 months, or after 6, 12, 18, 24, and 36 months. The efficacy parameters are total and cancer-specific mortality.


Options:
A: 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
B: 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.
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: 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.

Answer: C