Evaluating the safety and effectiveness of hyperthermia for advanced cancers
Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia with Radiotherapy And/or Chemotherapy in Locally Advanced Cancers At MGIMS
This study is testing if using heat treatment along with radiation and chemotherapy can help people with advanced cancers feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahatma Gandhi Institute of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sevāgrām, Maharashtra) |
| Trial ID | NCT05099809 on ClinicalTrials.gov |
What this trial studies
This observational registry trial aims to assess the safety and efficacy of hyperthermia delivered via a repurposed short wave diathermy unit in combination with radiotherapy and/or chemotherapy for patients with locally advanced cancers, including head and neck, cervical, breast, esophageal, and anorectal cancers. The study will collect uniform data on clinical outcomes such as locoregional tumor control, local disease-free survival, and overall survival, while also evaluating the safety and feasibility of this cost-effective treatment approach. Conducted at the Mahatma Gandhi Institute of Medical Sciences in rural India, the trial targets a patient population with limited resources and high mortality rates from cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histopathologically confirmed locally advanced cancers who have no metastatic disease and meet specific health criteria.
Not a fit: Patients with prior radiotherapy to the treatment site or concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, cost-effective treatment option for patients with advanced cancers, potentially improving survival rates and quality of life.
How similar studies have performed: While the use of hyperthermia in cancer treatment has been explored, this specific approach using a repurposed device in a rural setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sevāgrām, Maharashtra
- Mahatma Gandhi Institute of Medical Sciences, — Sevāgrām, Maharashtra, India (Recruiting)
Study contacts
- Study coordinator: Niloy R Datta, MD, DNB, CCST
- Email: niloydatta@mgims.ac.in
- Phone: +91 971 738 8117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.