Recruiting nowPhase 2Randomised
| Registry number | NCT07200141 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, blinded |
| Taking part | 156 people (planned) |
| Who can join | aged 18 Years to 80 Years |
| Run by | Peking Union Medical College Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost)
- Radiotherapy GTV 50 Gy/25 fractions(Simultaneous Integrated Boost)
- Drug Concurrent Chemotherapy
- Procedure Total mesorectal excision (TME) surgery or non-operative management
What it is measuring
CR
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
The goal of this clinical trial is to learn whether new adjuvant radiotherapy with gross tumor volume(GTV) escalated to 58.75 Gy can improve complete response (CR) rates compared with GTV dose of 50 Gy in adult patients (18-79 years) with locally advanced rectal adenocarcinoma (T3-T4/N+, M0) located ≤10 cm from the anal verge.The main questions it aims to answer are:
1. Does GTV simultaneously boost to 58.75 Gy/25f increase complete response (pCR or cCR) compared with 50 Gy/25f?
2. How do the two regimens differ in terms of progression-free survival (PFS), pelvic local control (LC), tumor regression grade (TRG), organ preservation, and treatment-related toxicity? Researchers will compare GTV 58.75 Gy/25f (experimental arm) versus GTV 50 Gy/25f (control arm) to see if dose escalation improves tumor response rate.Participants will:
1. Receive neoadjuvant radiotherapy with one of the two PGTV dose escalated regimens (with concurrent chemotherapy: oral capecitabine or XELOX).
2. Undergo restaging with imaging and clinical assessment before surgery or observation.
3. Proceed to total mesorectal excision (TME), local excision, or "watch-and-wait" strategy depending on treatment response and patient preference.
4. Be followed regularly with clinical exams, imaging, endoscopy, and laboratory tests to assess efficacy, safety, and long-term outcomes.Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07200141, registered by Peking Union Medical College Hospital on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.