Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia in Locally Advanced Cancers

Launched by MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES · Oct 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called hyperthermia for patients with locally advanced cancers, such as head and neck cancers, cervical cancer, and breast cancer. Hyperthermia involves raising the temperature of the tumor to help it respond better to standard cancer treatments like chemotherapy and radiotherapy. The goal is to see if this method can improve the outcomes for patients in a rural area of India where cancer care options are limited and prognosis is poor. The trial is specifically looking for adults over 18 who have certain types of advanced cancer that have not spread to other parts of the body.

To participate in this trial, patients must have a confirmed diagnosis of specific types of locally advanced cancer and be in generally good health, with no major issues affecting their liver or kidneys. They should be able to follow the study protocols and give informed consent. Participants can expect to receive hyperthermia treatment alongside their usual cancer therapies, and the study aims to ensure that this approach is safe and effective without adding significant side effects. This trial is important because it seeks to provide a cost-effective treatment option that could benefit patients in low-resource settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histopathologically proven cases of locally advanced head and neck cancers (LAHNC), TNM stages III and IV and locally advanced cancer cervix (LACC), FIGO stages IIB - IVA, locally advanced (primarily inoperable T3 and T4 stages) and recurrent breast cancers, cancer oesophagus (TNM stages IIA and IVA), anorectal cancers (TNM stages IIA to IIIC)
• • 2. Following work up, patients should have no metastatic disease (M0)
• • 3. Age \> 18 years
• • 4. Karnofsky performance status (KPS) ≥ 80
• • 5. Written informed consent and agree to comply with the protocol
• • 6. Adequate kidney and liver functions as assessed on biochemical investigations
• • 7. Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule
• Exclusion Criteria:
• • 1. Prior radiotherapy to the site of treatment
• • 2. No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin which are not in the area of the present malignancy
• • 3. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator would preclude the patient from meeting the study requirements.
• • 4. Patients having metal implants, pacemakers or clustered markers.
• • 5. Connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma
• • 6. Any known contraindication or hypersensitivity to the chemotherapeutic agents
• • 7. Pregnancy, lactation period or lack of reliable contraception
• • 8. Any other disease or therapy, which, according to the investigator, present a risk to the patient or which are not compatible with the aims of the clinical trial
• • 9. Indications that the person concerned will possibly not keep to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments
• • 10. Breast feeding female patients