HyperthermiaPUTHRC-001NCT05070832
Hyperthermia Combined With Neoadjuvant Radiochemotherapy for LARC
A study testing Deep Hyperthermia in people with Hyperthermia and Radiotherapy, run by Peking University Third Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthermia, Radiotherapy
- What is being tested?
- Deep Hyperthermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Deep Hyperthermia Combined With Neoadjuvant Concurrent Radiochemotherapy for Locally Advanced Rectal Cancer, PUTHRC-001：A Multi-Center, Open-Label, Randomized Controlled Study
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).
Read the 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
- Being tested
- Deep Hyperthermia
- Keywords
- locally advanced rectal cancer, hyperthermia, neoadjuvant therapy, chemoradiotherapy
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep HyperthermiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia Group | Experimental | The neoadjuvant therapy is hyperthermia combined with concurrent radiochemotherapy for this group. Receives: Procedure: Deep Hyperthermia |
| Non-hyperthermia group | No intervention | The neoadjuvant treatment is concurrent radiochemotherapy, which is standard treatment for LARC according to the guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor T-downstaging rate
T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.
Measured: 12 weeks
Secondary outcomes (9)
Tumor shrinkage percentage
（tumor volume before treatment-tumor volume before neoadjuvant treatment) /（ tumor volume before neoadjuvant treatment）
Measured: 12 weeks
Complete tumor resection rate
（patient number of R0 resection）/（total number of patients undergoing surgery）
Measured: 12 weeks
Pathological complete response rate
（number of patients with no residual tumors after neoadjuvant therapy）/（total number of patients undergoing surgery）
Measured: 12 weeks
Perioperative complication rate
（number of patients with complications before or after surgery）/（total number of patients undergoing surgery）
Measured: 4 months
Anal retention rate
（number of patients with anus preservation after surgery）/（total number of patients undergoing surgery）
Measured: 12 weeks
Disease-free survival
the time from random day to disease progression or death (whichever occurs first);
Measured: 3 year
Overall survival
the time between a random day and the day of death from any cause.
Measured: 3 year
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.
Measured: 3 year
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.
Measured: 3year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Hao Wang, Doctor, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070832
- Sponsor's protocol ID
- PUTHRC-001
- Acronym
- PUTHRC-001
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Hyperthermia Combined With Neoadjuvant Concurrent Radiochemotherapy for Locally Advanced Rectal Cancer, PUTHRC-001：A Multi-Center, Open-Label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05070832
- Acronym / sponsor ID
- PUTHRC-001 / PUTHRC-001
- Conditions
- Hyperthermia, Radiotherapy
- Keywords
- locally advanced rectal cancer, hyperthermia, neoadjuvant therapy, chemoradiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia Group | Experimental | Procedure: Deep HyperthermiaThe neoadjuvant therapy is hyperthermia combined with concurrent radiochemotherapy for this group. |
| Non-hyperthermia group | No intervention | –The neoadjuvant treatment is concurrent radiochemotherapy, which is standard treatment for LARC according to the guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep HyperthermiaHyperthermia 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. | Procedure or surgery | Hyperthermia Group |
Primary outcome
Tumor T-downstaging rate
Time frame: 12 weeks
T-downstaging is defined as the postoperative pathological T stage lower than the original T stage by imaging before treatment.
9 secondary outcomes
Tumor shrinkage percentage
Time frame: 12 weeks
Complete tumor resection rate
Time frame: 12 weeks
Pathological complete response rate
Time frame: 12 weeks
Perioperative complication rate
Time frame: 4 months
Anal retention rate
Time frame: 12 weeks
Disease-free survival
Time frame: 3 year
Overall survival
Time frame: 3 year
36-Item Short-Form Health Survey（SF-36）
Time frame: 3 year
Quality of Life Questionnaire-Core 30（QLQ-C30）
Time frame: 3year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Wang, Doctor study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Deep Hyperthermia in people with Hyperthermia and Radiotherapy, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Wang, Doctor (82264911, wanghaobysy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor T-downstaging rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.