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

NCT05099809 | Recruiting

• 1 other identifier: MahatmaIGMS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Advanced Malignant Neoplasm

Keywords

Hyperthermia; Radiotherapy; Chemotherapy; Registry trial; Short wave diathermy

Outcome Measures

Primary Outcomes (3)

• Locoregional tumour control

  Locoregional control of the tumour

  At 3 months after the completion of primary treatment

• Disease free survival

  From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed till end of the study completion, an average of 1 year

  Through study completion, an average of 1 year

• Overall survival

  From date of registration until the date of death from any cause, assessed till end of the study completion, an average of 1 year

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Acute treatment related morbidity

  Till 3 months following the completion of primary treatment

• Late treatment related morbidity

  Through study completion, an average of 1 year

Study Arms (1)

Hyperthermia

Patients with locally advanced cancers reporting to Department of Radiotherapy at MGIMS who fulfil the eligibility criteria would be included in the study. Depending on the ongoing departmental protocols for various tumors the patients could be treated with either: 1. Radiotherapy and Hyperthermia 2. Concurrent chemoradiotherapy and hyperthermia 3. Neoadjuvant chemotherapy and hyperthermia followed by surgery and/or radiotherapy Hyperthermia would be delivered using a shortwave diathermy unit operating at 27.1 MHz. Tumour response would be evaluated using RECIST criteria 1.1 while the acute and late morbidities would be scored as per CTCAE v5.0 guidelines. Outcome measures for each site would be undertaken and evaluated in terms of 1. Locoregional disease control 2. Disease free survival 3. Overall Survival 4. Acute morbidity 5. Late morbidity

Other: Hyperthermia

Interventions

Hyperthermia OTHER

Hyperthermia would be delivered once/twice a week for 60 to 90 minutes depending on patient's tolerance. A shortwave diathermy unit operating at 27.1 MHz would be used to deliver locoregional hyperthermia.

Also known as: Radiotherapy, Chemotherapy, Surgery

Hyperthermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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)
• Following work up, patients should have no metastatic disease (M0)
• Age \> 18 years
• Karnofsky performance status (KPS) ≥ 80
• Written informed consent and agree to comply with the protocol
• Adequate kidney and liver functions as assessed on biochemical investigations
• Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule

You may not qualify if:

• Prior radiotherapy to the site of treatment
• 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
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator would preclude the patient from meeting the study requirements.
• Patients having metal implants, pacemakers or clustered markers.
• Connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma
• Any known contraindication or hypersensitivity to the chemotherapeutic agents
• Pregnancy, lactation period or lack of reliable contraception
• 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
• 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
• Breast feeding female patients

Sponsors & Collaborators

• Mahatma Gandhi Institute of Medical Sciences: lead

Study Sites (1)

Mahatma Gandhi Institute of Medical Sciences,

Sevāgrām, Maharashtra, 442102, India

RECRUITING

Related Publications (7)

• Datta NR, Rogers S, Klingbiel D, Gomez S, Puric E, Bodis S. Hyperthermia and radiotherapy with or without chemotherapy in locally advanced cervical cancer: a systematic review with conventional and network meta-analyses. Int J Hyperthermia. 2016 Nov;32(7):809-21. doi: 10.1080/02656736.2016.1195924. Epub 2016 Aug 14.

  PMID: 27411568 BACKGROUND

• Kok HP, van der Zee J, Guirado FN, Bakker A, Datta NR, Abdel-Rahman S, Schmidt M, Wust P, Crezee J. Treatment planning facilitates clinical decision making for hyperthermia treatments. Int J Hyperthermia. 2021 Jan 1;38(1):532-551. doi: 10.1080/02656736.2021.1903583.

  PMID: 33784914 BACKGROUND

• Datta NR, Rogers S, Ordonez SG, Puric E, Bodis S. Hyperthermia and radiotherapy in the management of head and neck cancers: A systematic review and meta-analysis. Int J Hyperthermia. 2016;32(1):31-40. doi: 10.3109/02656736.2015.1099746. Epub 2015 Nov 16.

  PMID: 26928474 BACKGROUND

• Datta NR, Ordonez SG, Gaipl US, Paulides MM, Crezee H, Gellermann J, Marder D, Puric E, Bodis S. Local hyperthermia combined with radiotherapy and-/or chemotherapy: recent advances and promises for the future. Cancer Treat Rev. 2015 Nov;41(9):742-53. doi: 10.1016/j.ctrv.2015.05.009. Epub 2015 May 27.

  PMID: 26051911 BACKGROUND

• Datta NR, Kok HP, Crezee H, Gaipl US, Bodis S. Integrating Loco-Regional Hyperthermia Into the Current Oncology Practice: SWOT and TOWS Analyses. Front Oncol. 2020 Jun 12;10:819. doi: 10.3389/fonc.2020.00819. eCollection 2020.

  PMID: 32596144 BACKGROUND

• Datta NR, Puric E, Klingbiel D, Gomez S, Bodis S. Hyperthermia and Radiation Therapy in Locoregional Recurrent Breast Cancers: A Systematic Review and Meta-analysis. Int J Radiat Oncol Biol Phys. 2016 Apr 1;94(5):1073-87. doi: 10.1016/j.ijrobp.2015.12.361. Epub 2015 Dec 21.

  PMID: 26899950 BACKGROUND

• Datta NR, Jain BM, Mathi Z, Datta S, Johari S, Singh AR, Kalbande P, Kale P, Shivkumar V, Bodis S. Hyperthermia: A Potential Game-Changer in the Management of Cancers in Low-Middle-Income Group Countries. Cancers (Basel). 2022 Jan 9;14(2):315. doi: 10.3390/cancers14020315.

  PMID: 35053479 BACKGROUND

MeSH Terms

Conditions

Hyperthermia

Interventions

Diathermy; Radiotherapy; Drug Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Central Study Contacts

Niloy R Datta, MD, DNB, CCST

CONTACT

+91 971 738 8117; niloydatta@mgims.ac.in

Pratik D Aher, MD

CONTACT

+91 899 913 8749; pratikaher@mgims.ac.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-Professor & Head, Department of Radiotherapy

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: October 29, 2021
• Study Start: October 18, 2021
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)