Hyperthermia Combined With Neoadjuvant Radiochemotherapy for LARC

NCT05070832 | Unknown

• 1 other identifier: PUTHRC-001
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hyperthermia; Radiotherapy

Keywords

locally advanced rectal cancer; hyperthermia; neoadjuvant therapy; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Tumor T-downstaging rate

  T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.

  12 weeks

Secondary Outcomes (9)

• Tumor shrinkage percentage

  12 weeks

• Complete tumor resection rate

  12 weeks

• Pathological complete response rate

  12 weeks

• Perioperative complication rate

  4 months

• Anal retention rate

  12 weeks

Study Arms (2)

Hyperthermia Group

EXPERIMENTAL

The neoadjuvant therapy is hyperthermia combined with concurrent radiochemotherapy for this group.

Procedure: Deep Hyperthermia

Non-hyperthermia group

NO INTERVENTION

The neoadjuvant treatment is concurrent radiochemotherapy, which is standard treatment for LARC according to the guidelines.

Interventions

Deep Hyperthermia PROCEDURE

Hyperthermia is a type of treatment in which tumor is heated to as high as 40.5-43℃ to help damage and kill cancer cells with little or no harm to normal tissue.

Hyperthermia Group

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Beijing Friendship Hospital: collaborator

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Hao Wang, Doctor

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Hao Wang, Doctor

CONTACT

82264911; wanghaobysy@bjmu.edu.cn

Yuxia Wang

CONTACT

82265968; lily31415926@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 7, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share