Clinical trial · Interventional
Hyperthermia Combined With Neoadjuvant Radiochemotherapy for LARC
Deep Hyperthermia Combined With Neoadjuvant Concurrent Radiochemotherapy for Locally Advanced Rectal Cancer, PUTHRC-001:A Multi-Center, Open-Label, Randomized Controlled Study
NCT05070832CI-TRIAL-00054330PUTHRC-001unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether adding deep hyperthermia to neoadjuvant concurrent radiochemotherapy could improve T-downstaging rate for locally advanced rectal cancer (LARC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperthermia | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep Hyperthermia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperthermia Group
- description
- The neoadjuvant therapy is hyperthermia combined with concurrent radiochemotherapy for this group.
- interventionNames
- Procedure: Deep Hyperthermia
- type
- NO_INTERVENTION
- label
- Non-hyperthermia group
- description
- The neoadjuvant treatment is concurrent radiochemotherapy, which is standard treatment for LARC according to the guidelines.
Primary outcomes (1)
- measure
- Tumor T-downstaging rate
- timeFrame
- 12 weeks
- description
- T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years old * Pathologically diagnosed as rectal adenocarcinoma * Locally advanced rectal cancer (T3-4/N+) staging by CT, MRI and/or endoscopy * Males with fertility and females of childbearing age must take effective contraceptive measures at least since signing informed consent until 180 days after the end of concurrent radiotherapy and chemotherapy. Childbearing age means pre-menopausal or within 2 years after menopause. Women of childbearing age must exclude pregnancy before concurrent radiotherapy and chemotherapy * Patients with normal organ function prior to treatment, the following criteria are met:a) blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥70×10e9/L; b) biochemical tests meet the following criteria: i) serum creatinine (Cr) ≤1.5 times of upper limit of normal (ULN) or creatinine clearance (CCr) ≥40ml/min; ii) total bilirubin (TBIL) ≤1.5 ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, e)Coagulation test: International Normalized Ratio (INR)≤ 1.5 × ULN, Prothrombin Time ≤ 1.5 × ULN Exclusion Criteria: * Patients with signet ring cell carcinoma or mucinous adenocarcinoma. * Patients who refuse to undergo hyperthermia or cannot cooperate with continuous follow-up. * Patients with severe bleeding tendency, severe infection, wounds or infections on the skin of the hyperthermia area. * Patients who have metal implants or pacemakers in their bodies who cannot tolerate excessively high temperatures. * Other primary malignant tumors occurred within 5 years before concurrent radiotherapy and chemotherapy, except for malignant tumors that have undergone radical treatment and are locally curable (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.). * Suffer from uncontrollable comorbid diseases, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina, arrhythmia, active peptic ulcer or bleeding disease. * Patients with a history of alcohol or drug abuse. * Patients who do not agree to participate in this study or unable to complete the informed consent process.
References
Publications (0)
Data not yet available
No reference posted for this study.