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Tests treatment safety and results for Rectal Cancer
Official title Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
ClinicalTrials.gov ID: NCT07095439
What this study is testing
- What it's testing
- Several trials showed that total neoadjuvant treatment (TNT) in stage II/III rectal cancer patients had better outcomes when compared with standard neoadjuvant long-course radiotherapy (CRT). Recently, based on the RAPIDO and POLISH II trials a short course radiotherapy (SCRT)-including TNT strategy had better oncologic outcomes and comparable toxicities.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients aged 18 years old till 70 years old.
- Pathologically confirmed rectal adenocarcinoma of low or mid rectum (less than 16 cm from the anal verge on endoscopy)
- Stage II and stage III by imaging (T3 N any M0 or T1-2 N+ve M0) [29]; staged with MRI rectal protocol or EUS.
- The disease was staged with CT imaging of chest, abdomen and pelvis pretreatment.
- Eastern Cooperative Oncology Group (ECOG) performance status= 0-2.
You likely can't join if
- Previous surgical treatment for rectal cancer or concurrent fistulising inflammatory bowel disease of the rectum.
- Surgical or medical inoperability.
- Previous pelvic radiotherapy.
- Second malignancy within the last 5 years.
- Patients with diseases that do not allow receipt of chemotherapy or radiotherapy as grade 3 neuropathy and severe cardiovascular disease.
See the full eligibility criteria
- Patients aged 18 years old till 70 years old.
- Pathologically confirmed rectal adenocarcinoma of low or mid rectum (less than 16 cm from the anal verge on endoscopy)
- Stage II and stage III by imaging (T3 N any M0 or T1-2 N+ve M0) [29]; staged with MRI rectal protocol or EUS.
- The disease was staged with CT imaging of chest, abdomen and pelvis pretreatment.
- Eastern Cooperative Oncology Group (ECOG) performance status= 0-2.
- The following laboratory results are required: absolute neutrophilic count of 1.5 × 10⁹ cells per L or higher, platelet count of 100 × 10⁹ per L or higher, a clinically acceptable haemoglobin level, a creatinine level...
- Written informed consent.
- Previous surgical treatment for rectal cancer or concurrent fistulising inflammatory bowel disease of the rectum.
- Surgical or medical inoperability.
- Previous pelvic radiotherapy.
- Second malignancy within the last 5 years.
- Patients with diseases that do not allow receipt of chemotherapy or radiotherapy as grade 3 neuropathy and severe cardiovascular disease.
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.