NCT05070832

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperthermia
• Radiotherapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-10-07
• Last updated: 2021-10-07