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The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:
Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short course RT followed by full course of chemotherapy then surgery | Experimental | Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short course radiation therapy followed by 6 cycles of CAPOX then surgery | Radiation | Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) | No residual disease in surgical specimen | within 30 days |
| clinical complete response(cCR) | No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy | within 30 days |
| Sphincter saving surgery | Patients who were deemed abdomino-perineal resection before treatment start & were able to undergo low anterior resection after end of treatment | within 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local control | defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure. | 3 years |
| Overall survival | defined as period from diagnosis till last follow up or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | الجيزة | 11796 | Egypt |
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| 3 years |
| Disease free survival | defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure or distant failure, whichever comes first. | within 3 years |