Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients

NCT07095439 | Recruiting Phase 2 DMC

• 1 other identifier: FMASU MD200/2023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Short course radiotherapy; Total neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  The complete disappearance of all signs of cancer in tissue samples after treatment with chemotherapy and radiation therapy.

  6 months, from induction chemotherapy till total mesorectal excision

Study Arms (1)

Total neoadjuvant treatment via short course radiotherapy

EXPERIMENTAL

Participants in this arm receive 4 cycles of induction chemotherapy CAPEOX (or 5 cycles of FOLFOX6), followed by short course radiotherapy (25 Gy in 5 fractions) delivered via IMRT technique ,then consolidation chemotherapy in the form of : 2 cycles of CAPOX (or, 4 cycles of FOLFOX6). Total mesorectal excision (TME) will be performed for non-metastatic patients within 8-12 weeks of the short course radiotherapy.

Radiation: Total Neoadjuvant Treatment

Interventions

Total Neoadjuvant Treatment RADIATION

Participants in this arm receive 4 cycles of induction chemotherapy CAPEOX (or 5 cycles of FOLFOX6), followed by short course radiotherapy (25 Gy in 5 fractions) delivered via IMRT technique ,then consolidation chemotherapy in the form of : 2 cycles of CAPOX (or, 4 cycles of FOLFOX6). Total mesorectal excision (TME) will be performed for non-metastatic patients within 8-12 weeks of the short course radiotherapy.

Also known as: Short course radiotherapy

Total neoadjuvant treatment via short course radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Clinical oncology and nuclear medicine Department, Faculty of medicine, Ain Shams University

Cairo, 1181, Egypt

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Khaled M Abdel Karim, MD

  Faculty of medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Nesreen A Mosalam, MD

  Faculty of medicine, Ain Shams University

  STUDY DIRECTOR

• Lamiaa M Ahmed, MD

  Faculty of medicine, Ain Shams University

  STUDY DIRECTOR

• Sara E Zaki, MD

  Faculty of medicine, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Hadeer H Mohamed, MSc

CONTACT

+201061214926; hadeer.h.mohamed20@gmail.com

Sara E Zaki, MD

CONTACT

sara.zaki@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)