Hyperthermia Combined With Neoadjuvant Radiochemotherapy for LARC

Radiotherapy Clinical Trial

— PUTHRC-001  

Official title:

Deep Hyperthermia Combined With Neoadjuvant Concurrent Radiochemotherapy for Locally Advanced Rectal Cancer, PUTHRC-001：A Multi-Center, Open-Label, Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05070832
• Other study ID #: PUTHRC-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2021
• Source: Peking University Third Hospital
• Contact: Hao Wang, Doctor
• Phone: 82264911
• Email: wanghaobysy[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Radiotherapy

Intervention

Procedure:
• Deep Hyperthermia
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Chao Yang Hospital, Beijing Friendship Hospital

Outcome

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