Actively Recruiting
Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia in Locally Advanced Cancers
Led by Mahatma Gandhi Institute of Medical Sciences · Updated on 2024-09-19
500
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, District Wardha, Maharashtra, India is located in a rural setup and caters to a very underprivileged patient population with limited resources to even pay for their treatment. As per the latest Indian Cancer Registry Report 2020, of the 28 population based cancer registries (PBCR), the age adjusted incidence rates (AAR) in males and females are 64.9 and 69.9. This makes the AAR in Wardha District (district where MGIMS is located) as one of the lowest ranked AAR both for male (national range: 39.5 - 269.4) and females (national range: 49.4 - 219.8) in the country. However, the %mortality / incidence, is one of the highest for Wardha, both for males (65.9%, national range: 14.7% - 71.9%) and females (53%, national range: 9% - 63%). This indicates that the prognosis of patients in this district is one of the worst in India and thus requires a new approach to their standard therapeutic option. This has to be cost-effective, without any significant additional morbidity, and should used in conjunction to the standard treatment of radiotherapy and/or chemotherapy. Hyperthermia, which is raising the tumor temperature to 40 - 43°C is perhaps one of the oldest forms of treatment for cancer. Hyperthermia, being a potent radiosensitizer, a chemosensitizer, an immunomodulator with no significantly added side effects, could be an effective therapeutic modality that could be expected to improve the outcome in these patients. However, it also needs to be cost-effective and require low capital cost investment so that other centers, especially in low and low-middle income countries could also introduce hyperthermia to the therapeutic armamentarium for cancer. This is a registry trial for patients being treated with hyperthermia along with radiotherapy and/or chemotherapy as per the standard departmental protocol for various locally advanced cancers.
CONDITIONS
Official Title
Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia in Locally Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically proven locally advanced head and neck cancers (stages III and IV), locally advanced cancer cervix (FIGO stages IIB - IVA), inoperable T3 and T4 and recurrent breast cancers, oesophagus (stages IIA and IVA), anorectal cancers (stages IIA to IIIC)
- No metastatic disease after evaluation
- Age over 18 years
- Karnofsky performance status of 80 or higher
- Written informed consent and agreement to follow the study protocol
- Adequate kidney and liver function based on laboratory tests
- No psychological, family, social, or geographic issues likely to affect compliance with the study or follow-up
You will not qualify if you...
- Prior radiotherapy to the treatment site
- Any previous or concurrent cancers except surgically treated skin squamous or basal cell carcinoma not near the current cancer
- Psychiatric or addictive disorders or other conditions that prevent meeting study requirements
- Presence of metal implants, pacemakers, or clustered markers
- Connective tissue disorders that contraindicate radiotherapy such as scleroderma
- Known allergy or intolerance to chemotherapy drugs
- Pregnancy, breastfeeding, or no reliable contraception
- Any other diseases or treatments posing risk or incompatible with the trial
- Likely inability or unwillingness to comply with the study plan or attend follow-ups
- Female patients who are breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mahatma Gandhi Institute of Medical Sciences,
Sevāgrām, Maharashtra, India, 442102
Actively Recruiting
Research Team
N
Niloy R Datta, MD, DNB, CCST
CONTACT
P
Pratik D Aher, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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