Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521827
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2 on day 1 followed by oral capecitabine 1000 mgm2 twice daily on days 1-14 in a 3-week cycle or folfox leucovorin calcium IV 200 mgm2 on day 121516 5 fluorouracil IV 600 mgm2 on day 121516 oxaliplatin IV 85 mgm2 on day 1 15 plus target agent according to RAS status if wild for bevacizumab IV 5 mlkg on day 1 15 or cetiximab IV 250 mgm2 on day 1815 22 or vectibex IV 6mgkg on day 115
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
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 mgm2 on day 1 followed by oral capecitabine 1000 mgm2 twice daily on days 1-14 in a 3-week cycle or folfox leucovorin calcium IV 200 mgm2 on day 121516 5 fluorouracil IV 600 mgm2 on day 121516 oxaliplatin IV 85 mgm2 on day 1 15 plus target agent according to RAS status if wild for bevacizumab IV 5 mlkg on day 1 15 or cetiximab IV 250 mgm2 on day 1815 22 or vectibex IV 6mgkg on day 115
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None