NCT07095439 Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
| NCT ID | NCT07095439 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ain Shams University |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2023-09-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Moreover, cost-effectively, an SCRT-including TNT strategy is more convenient than a CRT-based TNT approach. In addition, systemic chemotherapy is often used to treat occult or micrometastatic disease in intermediate and locally advanced rectal cancer. However, the timing of chemotherapy delivery remains a topic of debate. In this context, and since rapid access to radiotherapy treatment is limited, especially in developing countries, a TNT strategy whereby adjuvant chemotherapy is replaced by systemic chemotherapy delivered before and after SCRT according to a "sandwich" treatment can avoid delays in treatment start with equivalent outcomes.
Eligibility Criteria
Inclusion 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 indicating renal clearance of 50 mL/min or higher, and bilirubin level below 2 mg/dL. * Written informed consent. Exclusion Criteria: * · 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.
Contact & Investigator
Khaled M Abdel Karim, MD
PRINCIPAL INVESTIGATOR
Faculty of medicine, Ain Shams University
Frequently Asked Questions
Who can join the NCT07095439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07095439 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07095439 currently recruiting?
Yes, NCT07095439 is actively recruiting participants. Contact the research team at hadeer.h.mohamed20@gmail.com for enrollment information.
Where is the NCT07095439 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07095439 clinical trial?
NCT07095439 is sponsored by Ain Shams University. The principal investigator is Khaled M Abdel Karim, MD at Faculty of medicine, Ain Shams University. The trial plans to enroll 38 participants.
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