Actively Recruiting

Age: 18Years +
All Genders
ID05099809

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

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Trial Site Locations

Total: 1 location

1

Mahatma Gandhi Institute of Medical Sciences,

Sevāgrām, Maharashtra, India, 442102

Actively Recruiting

Loading map...

Research Team

N

Niloy R Datta, MD, DNB, CCST

P

Pratik D Aher, MD

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

Similar Trials

Multicentric Phase II-III Study Evaluating Personalized Trea...

Locally Advanced Malignant Neoplasm

Actively Recruiting

30 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Hyperthermia and radiotherapy with or without chemotherapy in locally advanced cervical cancer: a systematic review with conventional and network meta-analyses.

Niloy R Datta, Susanne Rogers, Dirk Klingbiel...

https://pubmed.ncbi.nlm.nih.gov/27411568

Hyperthermia and radiotherapy in the management of head and neck cancers: A systematic review and meta-analysis.

Niloy R Datta, Susanne Rogers, Silvia Gómez Ordóñez...

https://pubmed.ncbi.nlm.nih.gov/26928474

Hyperthermia and Radiation Therapy in Locoregional Recurrent Breast Cancers: A Systematic Review and Meta-analysis.

Niloy R Datta, Emsad Puric, Dirk Klingbiel...

https://pubmed.ncbi.nlm.nih.gov/26899950