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| Name | Class |
|---|---|
| Vrije Universiteit Brussel | OTHER |
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The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant chemoradiotherapy | Active Comparator | Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends |
|
| Radiotherapy with boost | Experimental | Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoradiotherapy | Other | Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction in metabolic tumor activity | at baseline and at 5 to 6 weeks after neo-adjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| histological downgrading (Dworak classification) | pathological evaluation of surgical resection specimens | after the rectum surgery |
| number of R0, R1 and R2 resections | pathological evaluation of surgical resection specimens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark De Ridder, Prof.Dr. | UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie | Jette | Brussels Capital | 9010 | Belgium | ||
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D000069287 | Capecitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D003841 | Deoxycytidine |
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| Radiotherapy with boost | Radiation | Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor |
|
|
| after the rectum surgery |
| acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years |
| local control | every 6 months in the first year after completion of radiotherapy and then yearly until 3 years |
| progression free survival | every 6 months in the first year after completion of radiotherapy and then yearly until 3 years |
| survival | overall survival | every 6 months in the first year after completion of radiotherapy and then yearly until 3 years |
| quality of life | at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years |
| cost evaluation | during the treatment and follow-ups |
| UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie |
| Jette |
| 1090 |
| Belgium |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |