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Trial Title:
The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum
NCT ID:
NCT06521827
Condition:
Metastatic Cancer Rectum
Conditions: Official terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
short course radiotherapy
Description:
short course palliative radiotherapy
Arm group label:
short course radiotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adenocarcinoma pathological evidence in rectal carcinoma.
2. Metastatic unresectable rectal cancer.
3. Symptomatic disease for at least one of the following signs: bleeding, pain,
tenesmus, obstruction,
Exclusion Criteria:
1. Previous radiotherapy.
2. Concomitant chemotherapy.
3. Previously created stoma.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521827
