Locally Advanced Malignant NeoplasmRESHMARTNCT05099809
Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia in Locally Advanced Cancers
An observational study of Locally Advanced Malignant Neoplasm, run by Mahatma Gandhi Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Malignant Neoplasm
- What is being tested?
- Hyperthermia
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 18 Oct 2021to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Mahatma Gandhi Institute of Medical Sciences,
Sevāgrām, Maharashtra, 442102
Niloy R Datta, MD, DNB, +919717388117, niloydatta@magims.ac.in
Ashok R Singh, MD, +918698552500, ashoksingh@mgims.ac.in
About this study
Official title: Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia with Radiotherapy And/or Chemotherapy in Locally Advanced Cancers At MGIMS
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.
Read the detailed description
To carry out a registry trial to evaluate the safety and efficacy of hyperthermia delivered by a repurposed short wave diathermy unit working at 27.1 MHz along with radiotherapy and/or chemotherapy in patients with locally advanced tumours of head neck cancers, cancer cervix, breast, oesophagus and anorectum attending the department of radiotherapy, MGIMS.
This would help to create an organized system that uses observational methods to collect uniform data on safety and efficacy of hyperthermia when used in conjunction with standard therapeutic modalities of radiotherapy and/or chemotherapy. The study would help to,
- Evaluate the specific outcomes with hyperthermia in terms of the following clinical endpoints with hyperthermia
- Locoregional tumour control
- Local disease free survival
- Overall survival ii. Evaluate the safety of hyperthermia along with standard therapeutic modalities of radiotherapy and/or chemotherapy
- Acute morbidity
- Late morbidity iii. Evaluate the feasibility of carrying out hyperthermia by repurposing 27.12 MHz short wave diathermy unit that could be cost-effective
- Conditions
- Locally Advanced Malignant Neoplasm
- Being tested
- Hyperthermia
- Keywords
- Hyperthermia, Radiotherapy, Chemotherapy, Registry trial, Short wave diathermy
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaOther
Also called Radiotherapy, Chemotherapy, Surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional tumour control
Locoregional control of the tumour
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Acute treatment related morbidity
Acute treatment morbidity as per CTCAE 5.0 guidelines
Measured: Till 3 months following the completion of primary treatment
Late treatment related morbidity
Late treatment morbidity as per CTCAE 5.0 guidelines
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start18 Oct 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahatma Gandhi Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niloy Ranjan Datta, Mahatma Gandhi Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099809
- Sponsor's protocol ID
- MahatmaIGMS
- Acronym
- RESHMART
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27411568Kok 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.
PubMed 33784914Datta 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.
PubMed 26928474Datta 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.
PubMed 26051911Datta 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.
PubMed 32596144Datta 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.
PubMed 26899950Datta 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.
PubMed 35053479
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia with Radiotherapy And/or Chemotherapy in Locally Advanced Cancers At MGIMS
- ClinicalTrials.gov ID
- NCT05099809
- Acronym / sponsor ID
- RESHMART / MahatmaIGMS
- Conditions
- Locally Advanced Malignant Neoplasm
- Keywords
- Hyperthermia, Radiotherapy, Chemotherapy, Registry trial, Short wave diathermy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mahatma Gandhi Institute of Medical SciencesUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To carry out a registry trial to evaluate the safety and efficacy of hyperthermia delivered by a repurposed short wave diathermy unit working at 27.1 MHz along with radiotherapy and/or chemotherapy in patients with locally advanced tumours of head neck cancers, cancer cervix, breast, oesophagus and anorectum attending the department of radiotherapy, MGIMS.
This would help to create an organized system that uses observational methods to collect uniform data on safety and efficacy of hyperthermia when used in conjunction with standard therapeutic modalities of radiotherapy and/or chemotherapy. The study would help to,
- Evaluate the specific outcomes with hyperthermia in terms of the following clinical endpoints with hyperthermia
- Locoregional tumour control
- Local disease free survival
- Overall survival ii. Evaluate the safety of hyperthermia along with standard therapeutic modalities of radiotherapy and/or chemotherapy
- Acute morbidity
- Late morbidity iii. Evaluate the feasibility of carrying out hyperthermia by repurposing 27.12 MHz short wave diathermy unit that could be cost-effective
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia | – | Other: HyperthermiaPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperthermiaAlso: Radiotherapy, Chemotherapy, SurgeryHyperthermia 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. | Other | Hyperthermia |
Primary outcome
Locoregional tumour control
Time frame: At 3 months after the completion of primary treatment
Locoregional control of the tumour
Disease free survival
Time frame: Through study completion, an average of 1 year
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
Overall survival
Time frame: Through study completion, an average of 1 year
From date of registration until the date of death from any cause, assessed till end of the study completion, an average of 1 year
2 secondary outcomes
Acute treatment related morbidity
Time frame: Till 3 months following the completion of primary treatment
Late treatment related morbidity
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 27411568Datta 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.
- Background: PubMed 33784914Kok 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.
- Background: PubMed 26928474Datta 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.
- Background: PubMed 26051911Datta 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.
- Background: PubMed 32596144Datta 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.
- Background: PubMed 26899950Datta 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.
- Background: PubMed 35053479Datta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Malignant Neoplasm, run by Mahatma Gandhi Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niloy R Datta, MD, DNB, CCST (+91 971 738 8117, niloydatta@mgims.ac.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional tumour control (time frame: At 3 months after the completion of primary treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099809, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.