Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia with Radiotherapy and/or Chemotherapy in Locally Advanced Cancers at MGIMS
Led by Mahatma Gandhi Institute of Medical Sciences · Updated on 2024-09-19
500
Participants Needed
1
Research Sites
26 weeks
Total Duration
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What this Trial Is About
Researchers are evaluating the safety and effectiveness of hyperthermia combined with radiotherapy and/or chemotherapy in patients with locally advanced cancers such as head and neck, cervix, breast, oesophagus, and anorectal cancers. This registry trial is conducted at MGIMS in a rural setting with limited resources, focusing on cost-effective cancer treatments that do not add significant side effects. Hyperthermia is being studied as a treatment that raises tumor temperature to enhance the effects of radiotherapy and chemotherapy while being affordable for low-income settings.
Hyperthermia treatment is delivered using a repurposed shortwave diathermy machine operating at 27.1 MHz. Patients receive hyperthermia once or twice weekly for 60 to 90 minutes, depending on their tolerance. They may be treated with radiotherapy and hyperthermia, concurrent chemoradiotherapy and hyperthermia, or neoadjuvant chemotherapy and hyperthermia followed by surgery or radiotherapy. Tumor responses and treatment side effects are assessed using standard clinical criteria during and after treatment.
Participants undergo evaluations of tumor control, disease-free survival, and overall survival at scheduled time points, including 3 months and about 1 year after treatment. Safety is monitored by recording acute and late treatment-related side effects. Researchers also assess the feasibility of using the modified diathermy device for delivering hyperthermia. The study involves regular follow-up visits and clinical assessments to collect uniform data on outcomes and safety over the study period.
CONDITIONS
Brief Title
Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia in Locally Advanced Cancers
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Histopathologically confirmed locally advanced cancers of head and neck (stages III and IV), cervix (stages IIB to IVA), breast (inoperable T3 and T4 stages and recurrent), oesophagus (stages IIA and IVA), or anorectal (stages IIA to IIIC)
No metastatic disease after workup (M0)
Age greater than 18 years
Karnofsky performance status of 80 or higher
Written informed consent and agreement to follow study protocol
Adequate kidney and liver function based on tests
No psychological, social, or geographical conditions that would prevent compliance with the study and follow-up
You will not qualify if you...
Prior radiotherapy to the treatment site
Other prior or concurrent cancers except certain skin cancers not near the current malignancy
Psychiatric or addictive disorders or other conditions preventing study participation
Presence of metal implants, pacemakers, or clustered markers
Connective tissue disorders that contraindicate radiotherapy, such as scleroderma
Known allergy or contraindication to chemotherapy drugs
Pregnancy, breastfeeding, or no reliable contraception
Any other disease or therapy posing risk or incompatible with study aims
Likely inability to follow study plan or attend follow-ups
Breastfeeding female patients
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of standard treatment protocols depending on tumor type and stage
Participants receive hyperthermia treatment once or twice a week using a shortwave diathermy unit in combination with radiotherapy and/or chemotherapy according to standard departmental protocols.
Weekly visits for hyperthermia treatments
Follow-up
Duration - Up to 1 year after treatment completion
Participants are monitored for tumor response, acute and late treatment-related morbidity, disease-free survival, and overall survival after completing their primary treatment.
Visits for assessments at 3 months and periodic follow-ups up to 1 year
Hyperthermia and radiotherapy with or without chemotherapy in locally advanced cervical cancer: a systematic review with conventional and network meta-analyses.