Metastatic Cancer RectumNCT06521827
The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum
A study testing short course radiotherapy in people with Metastatic Cancer Rectum, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Cancer Rectum
- What is being tested?
- short course radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adenocarcinoma pathological evidence in rectal carcinoma.
- Metastatic unresectable rectal cancer.
- Symptomatic disease for at least one of the following signs: bleeding, pain, tenesmus, obstruction,
Who cannot join
- Previous radiotherapy.
- Concomitant chemotherapy.
- Previously created stoma.
About this study
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.
Read the 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.
- Conditions
- Metastatic Cancer Rectum
- Being tested
- short course radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short course radiotherapyRadiation
short course palliative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| short course radiotherapy | Experimental | patients with metastatic rectal cancer will receive short course of radiotherapy befor staring chemotherapy Receives: Radiation: short course radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of short course of palliative radiation in metastatic cancer rectum.
The role of short course of palliative radiation in metastatic cancer rectum.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metastatic Cancer RectumStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehdaa Khaled Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521827
- Sponsor's protocol ID
- SCRTH in rectal cancer
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santucci C, Mignozzi S, Malvezzi M, Boffetta P, Collatuzzo G, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2024 with focus on colorectal cancer. Ann Oncol. 2024 Mar;35(3):308-316. doi: 10.1016/j.annonc.2023.12.003. Epub 2024 Jan 28.
PubMed 38286716Flyum IR, Mahic S, Grov EK, Joranger P. Health-related quality of life in patients with colorectal cancer in the palliative phase: a systematic review and meta-analysis. BMC Palliat Care. 2021 Sep 16;20(1):144. doi: 10.1186/s12904-021-00837-9.
PubMed 34530833Yoo RN, Cho HM, Kye BH. Management of obstructive colon cancer: Current status, obstacles, and future directions. World J Gastrointest Oncol. 2021 Dec 15;13(12):1850-1862. doi: 10.4251/wjgo.v13.i12.1850.
PubMed 35070029van Hooft JE, Veld JV, Arnold D, Beets-Tan RGH, Everett S, Gotz M, van Halsema EE, Hill J, Manes G, Meisner S, Rodrigues-Pinto E, Sabbagh C, Vandervoort J, Tanis PJ, Vanbiervliet G, Arezzo A. Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 May;52(5):389-407. doi: 10.1055/a-1140-3017. Epub 2020 Apr 7.
PubMed 32259849Tissera NS, Freile B, Waisberg F, Esteso F, Galli M, Loria FS, Luca R, Pedraza II, Enrico DH, Chacon C, Huertas E, Chacon MR, O'Connor JM. Short-course radiotherapy for rectal cancer: real-world evidence in Argentina. Ecancermedicalscience. 2023 Jun 1;17:1555. doi: 10.3332/ecancer.2023.1555. eCollection 2023.
PubMed 37396101
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Short Course of Palliative Radiation in Metastatic Cancer Rectum
- ClinicalTrials.gov ID
- NCT06521827
- Acronym / sponsor ID
- SCRTH in rectal cancer
- Conditions
- Metastatic Cancer Rectum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| short course radiotherapy | Experimental | Radiation: short course radiotherapypatients with metastatic rectal cancer will receive short course of radiotherapy befor staring chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adenocarcinoma pathological evidence in rectal carcinoma.
- Metastatic unresectable rectal cancer.
- Symptomatic disease for at least one of the following signs: bleeding, pain, tenesmus, obstruction,
Key exclusion criteria (3 listed)
- Previous radiotherapy.
- Concomitant chemotherapy.
- Previously created stoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short course radiotherapyshort course palliative radiotherapy | Radiation | short course radiotherapy |
Primary outcome
The role of short course of palliative radiation in metastatic cancer rectum.
Time frame: one year
The role of short course of palliative radiation in metastatic cancer rectum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 38286716Santucci C, Mignozzi S, Malvezzi M, Boffetta P, Collatuzzo G, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2024 with focus on colorectal cancer. Ann Oncol. 2024 Mar;35(3):308-316. doi: 10.1016/j.annonc.2023.12.003. Epub 2024 Jan 28.
- Background: PubMed 34530833Flyum IR, Mahic S, Grov EK, Joranger P. Health-related quality of life in patients with colorectal cancer in the palliative phase: a systematic review and meta-analysis. BMC Palliat Care. 2021 Sep 16;20(1):144. doi: 10.1186/s12904-021-00837-9.
- Background: PubMed 35070029Yoo RN, Cho HM, Kye BH. Management of obstructive colon cancer: Current status, obstacles, and future directions. World J Gastrointest Oncol. 2021 Dec 15;13(12):1850-1862. doi: 10.4251/wjgo.v13.i12.1850.
- Background: PubMed 32259849van Hooft JE, Veld JV, Arnold D, Beets-Tan RGH, Everett S, Gotz M, van Halsema EE, Hill J, Manes G, Meisner S, Rodrigues-Pinto E, Sabbagh C, Vandervoort J, Tanis PJ, Vanbiervliet G, Arezzo A. Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 May;52(5):389-407. doi: 10.1055/a-1140-3017. Epub 2020 Apr 7.
- Background: PubMed 37396101Tissera NS, Freile B, Waisberg F, Esteso F, Galli M, Loria FS, Luca R, Pedraza II, Enrico DH, Chacon C, Huertas E, Chacon MR, O'Connor JM. Short-course radiotherapy for rectal cancer: real-world evidence in Argentina. Ecancermedicalscience. 2023 Jun 1;17:1555. doi: 10.3332/ecancer.2023.1555. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing short course radiotherapy in people with Metastatic Cancer Rectum, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of short course of palliative radiation in metastatic cancer rectum. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521827, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.