Simultaneous GTV Dose Boost with Neoadjuvant Radiotherapy for Locally Advanced Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 2 trial compares two neoadjuvant radiotherapy regimens for locally advanced rectal cancer. Both arms use IMRT or VMAT with concurrent chemotherapy, but the experimental arm escalates the GTV dose to 58.75 Gy in 25 fractions while the control arm uses 50 Gy in 25 fractions. After radiotherapy, patients undergo restaging and then may proceed to surgery or non-operative management based on response. The study aims to see if higher GTV dosing increases complete response rates and affects progression-free survival, local control, organ preservation, and treatment-related toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 and \<80 years
2. Histologically confirmed rectal adenocarcinoma
3. Tumor located within 10 cm from the anal verge
4. MRI staging: T3-T4 and/or N+, M0 (AJCC 8th edition)
5. ECOG performance status 0-2
6. Adequate bone marrow function: WBC ≥3×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L
7. Adequate liver function: TBIL ≤1.5 × ULN, ALT/AST ≤2.5 × ULN
8. Adequate renal function: Cr ≤1.5 × ULN or CCr ≥60 mL/min
9. Signed informed consent

Exclusion Criteria:

1. Prior rectal cancer surgery
2. Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy
3. History of other malignancies
4. History of chronic colitis, ulcerative colitis, or nonspecific proctitis
5. Pregnant or breastfeeding women
6. Active infection or fever
7. Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders)
8. Inability to comply with study protocol

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: ke hu
• Email: huke8000@126.com
• Phone: 86-010-69155482

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination treatment for rectal adenocarcinoma using botensilimab and balstilimab

  This study is testing a new combination treatment with botensilimab and balstilimab to see if it can help people with locally advanced rectal cancer feel better with fewer side effects than regular chemotherapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06843434

• Papaverine combined with radiation therapy for advanced rectal cancer

  This study is testing if adding papaverine to radiation therapy can help people with advanced rectal cancer feel better and improve their treatment results.

  Recruiting Phase 1 City of Hope Medical Center · Duarte, California · NCT06834126

• Combining Tucatinib and Trastuzumab for HER2 Positive Rectal Cancer

  This study is testing if combining two cancer drugs, tucatinib and trastuzumab, with standard chemotherapy can help people with HER2 positive rectal cancer have better treatment results.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT05672524

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.