Please select the eligibility criteria that correspond to the clinical trial below.
Title: STAR-TREC: Can We Save the Rectum by Watchful Waiting or TransAnal Surgery Following (chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?
Brief Summary: Bowel cancer is the second most common tumour with 41 000 new cases diagnosed annually in the UK, 447 000 across Europe and 1.36 million worldwide; of which one third are located in the rectum. Standard primary radical Total Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in approximately 10% of cases while many more patients have a temporary stoma, some of which are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic tumours, may not be the optimal method of treatment for early screen-detected tumours and an organ preserving strategy may generate significantly less morbidity without substantially compromising oncological outcomes.

STAR-TREC is a rolling phase II/III study. Phase II aimed to assess the feasibility of a large, multi-centre randomised trial comparing radical surgery versus two contrasting organ saving treatments followed by selective transanal microsurgery. Phase III will evaluate two contrasting organ preservation strategies in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL).


Options:
A: Inclusion Criteria:

* T2T3 low adenocarcinoma of the rectum
* Tumour size =\< 4cm
* Less than 8 cm from the anal verge
* No metastatic disease
* Patient is at least 18 years of age
* ECOG performance status score =\< 2
* Patient and doctor have signed informed consent
* inclusion criteria : Residual clinical tumour size =\< 2cm after radiochemotherapy

Exclusion Criteria:

* T1, T4 tumour or anal sphincter invasion
* Metastatic disease (M1)
* Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy
* History of cancer
* Symptomatic cardiac or coronary insufficiency
* Severe renal insufficiency
* Peripheral neuropathy
* Patient included in a trial
B: 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.
C: 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
D: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum
* MRI-defined ≤T3b (with ≤5mm of mesorectal invasion) rectal tumour or endorectal ultrasound-defined ≤uT3b rectal cancer (optional: in centres where high quality endorectal ultrasound (ERUS) is available or patient unable to tolerate MRI)
* MDT determines that all of the following treatment options are reasonable and feasible:

  --TME surgery, (b) CRT (c) SCRT d) TEM.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* For patients choosing organ preservation only:

  * If female and of childbearing potential, must:

    * Have a negative pregnancy test within 7 days prior to study entry
    * Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment
  * If non-sterilised male male with a partner of childbearing potential, must:
  * Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment
* Patient able and willing to provide written informed consent for the study

Exclusion Criteria:

* Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years
* Unequivocal evidence of metastatic disease (includes resectable metastases)

  -- Patients with equivocal radiological lesions (e.g. retroperitoneal, liver, lung) that are not classified as M1 are eligible if agreed by MDT
* MRI node positive (≥N1, defined by protocol guidelines)

  -- Patients with equivocal radiological findings that are either classified as NX or N0 are eligible
* MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)
* MRI defined mucinous tumour
* Mesorectal fascia threatened (≤1 mm on MRI or ERUS)
* Maximum tumour diameter \> 40mm (either measured from everted edges on sagittal MRI or on ERUS)
* Tumour position anterior, above the peritoneal reflection on MRI or EUS
* No residual luminal tumour following endoscopic resection
* Contraindications to radiotherapy including previous pelvic radiotherapy
* Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
* Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
* Known Gilbert's disease (hyperbilirubinaemia)
* Taking coumarin-derivative anticoagulants (e.g. warfarin) that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin
* Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine, within 4 weeks of trial entry (see Section 8.3.5 for further details)
* Taking metronidazole at study entry
* Pregnant or lactating women
* History of severe and unexpected reactions to fluoropyrimidine therapy
* Age \<16 years (UK), \<18 years (other countries)

Answer: D