Hyperthermia Combined With Neoadjuvant Radiochemotherapy for LARC

Not Applicable

Not yet recruiting

• Conditions: Hyperthermia; Radiotherapy
• Interventions: Procedure: Deep Hyperthermia

• Registration Number: NCT05070832
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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).

Detailed Description

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). The sample size is 142. Patients with LARC (T3-4/N+) will be randomly divided into intervention group and control group. For intervention group, the neoadjuvant therapy is hyperthermia combined with concurrent radiochemotherapy. For control group, the neoadjuvant treatment is concurrent radiochemotherapy. T-downstaging rate will be used to evaluate the effectiveness of deep hyperthermia. T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Study First Posted: 2021-10-07
• Last Update Posted: 2021-10-07
• Study Start: 2022-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 142

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperthermia Group	Deep Hyperthermia	The neoadjuvant therapy is hyperthermia combined with concurrent radiochemotherapy for this group.

Primary Outcome Measures

Name	Time	Method
Tumor T-downstaging rate	12 weeks	T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 year	the time between a random day and the day of death from any cause.
Pathological complete response rate	12 weeks	（number of patients with no residual tumors after neoadjuvant therapy）/（total number of patients undergoing surgery）
Perioperative complication rate	4 months	（number of patients with complications before or after surgery）/（total number of patients undergoing surgery）
Complete tumor resection rate	12 weeks	（patient number of R0 resection）/（total number of patients undergoing surgery）
Tumor shrinkage percentage	12 weeks	（tumor volume before treatment-tumor volume before neoadjuvant treatment) /（ tumor volume before neoadjuvant treatment）
Anal retention rate	12 weeks	（number of patients with anus preservation after surgery）/（total number of patients undergoing surgery）
Disease-free survival	3 year	the time from random day to disease progression or death (whichever occurs first);
36-Item Short-Form Health Survey（SF-36）	3 year	The minimum and maximum values of SF-36 are 30 and 150. Higher score means a better quality of life.
Quality of Life Questionnaire-Core 30（QLQ-C30）	3year	The minimum and maximum values of QLQ-C30 are 0 and 100. Higher score means a better quality of life.