The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum
- Conditions
- Metastatic Cancer Rectum
- Interventions
- Radiation: short course radiotherapy
- Registration Number
- NCT06521827
- Lead Sponsor
- Assiut University
- Brief Summary
Short-course radiotherapy (SCRT), which allows the delivery of 25 Gy in five daily fractions, has emerged as an attractive strategy for rectal cancer treatment. Surgery can safely be deferred after SCRT, allowing an opportunity to deliver chemotherapy (ChT) preoperatively rather than postoperatively. In cases of metastatic disease, this represents an effective treatment option to improve local control and avoid colostomy in a subset of patients.
- Detailed Description
All patients will be under go complete history and physical examination, proctoscopy and biopsy, followed by metastatic work up include chest X ray, pelvic abdominal CT.
Radiotherapy:
Target volume: all the gross primary disease and gross nodal involved plus 2 cm safety margin will be included. not involved node will not be included.
Dosage: total dose of 25 Gy over 5 fractions through 1 weak will be given. Time: Radiotherapy will be given first and chemotherapy will be given after 1 weak rest to avoid the over lapping toxicity.
Chemo therapy:
To be started after 1 weak rest after radiotherapy. CAPOX (oxaliplatin given intravenously at 130 mg/m2 on day 1, followed by oral capecitabine 1000 mg/m2 twice daily on days 1-14, in a 3-week cycle). or folfox (leucovorin calcium (IV 200 mg/m2 on day 1,2,15,16 ) + 5 fluorouracil (IV 600 mg/m2 on day 1,2,15,16)+ oxaliplatin (IV 85 mg/m2 on day 1, 15) plus target agent according to RAS status if wild for bevacizumab ( IV 5 ml/kg on day 1, 15) or cetiximab (IV 250 mg/m2 on day 1,8,15, 22) or vectibex (IV 6mg/kg on day 1,15)
Surgery:
Surgery if complete bowel obstruction as palliation or as treatment if controlled metastatic sites and primary
Follow up:
CT pelvi-abdomen will be done after 3 cycle of chemotherapy to assess the response then after end of CTH every 3 month in first year. Toxicity of RTH will be collected before and after RTH.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 49
- Adenocarcinoma pathological evidence in rectal carcinoma.
- Metastatic unresectable rectal cancer.
- Symptomatic disease for at least one of the following signs: bleeding, pain, tenesmus, obstruction,
- Previous radiotherapy.
- Concomitant chemotherapy.
- Previously created stoma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description short course radiotherapy short course radiotherapy patients with metastatic rectal cancer will receive short course of radiotherapy befor staring chemotherapy
- Primary Outcome Measures
Name Time Method The role of short course of palliative radiation in metastatic cancer rectum. one year The role of short course of palliative radiation in metastatic cancer rectum.
- Secondary Outcome Measures
Name Time Method