No Surgery Trial / Two Dose-escalation Strategies

Summary

A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Eligibility

Inclusion Criteria:

* Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound
* Rectal cancer staged as N0 by MRI or EUS/TRUS
* No metastatic lesion
* Rectal tumor occupying less than half of the circumference
* Tumor less than 5 cm on its largest dimension
* Tumor located at less than 10 cm from the anal verge
* Tumor penetration less than 5 mm in the mesorectal fat
* Tumor accessible for brachytherapy
* Lumen accessible for colonoscopy
* Patient should be a suitable candidate for brachytherapy and chemotherapy
* Older than 18 years of age
* Adequate birth control measures in women of childbearing potential
* Written informed consent

Exclusion Criteria:

* Patients with previous pelvic radiation
* Evidence of distant metastasis
* Extension of malignant disease to the anal canal
* Tumors staged as T4
* Tumors larger than 5 cm in length

Conditions2

Locations1 site

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