Phase III randomised trialRadiation therapy combined with hyperthermia versus cisplatin for locally advanced cervical cancer: Results of the randomized RADCHOC trial
Section snippets
Eligibility
The study protocol and consent procedure were approved by the Medical Ethics Review Board of participating centres. Patients with a biopsy proven cervical carcinoma FIGO-stage IB–IIA (⩾4 cm) or IIB–IVA, negative para-aortic lymph nodes (CT-scan short axis diameter ⩽ 1 cm), suitable to undergo radical radiotherapy combined with chemotherapy and/or hyperthermia and able to undergo brachytherapy, were eligible.
Clinical staging included pelvic examination under anaesthesia; pelvic MR-scan; abdominal
Results
This trial was closed prematurely because of poor accrual after 87 patients being enrolled between 2003 and 2009 (23% of 376 patients planned). Three patients were excluded from analysis: two with PAO lymph node metastases and one with distant metastasis. Intention to treat analyses encompassed 84 patients: 42 patients in the RT-CT arm and 42 patients in the RT-HT arm (Fig. 1). Patient and tumour characteristics were comparable (Table 1).
Discussion
The present trial comparing RT-CT to RT-HT in LACC, is underpowered. In addition tumour characteristics observed were significantly different from those anticipated when designing this trial, i.e. the majority of patients had tumours ⩽6 cm diameter and/or FIGO stage ⩽IIB, precluding any conclusion regarding the hypothesis to be tested. Nevertheless, important observations were made. For the current patient population with LACC FIGO stage significantly correlated with EFS and OS, whereas clinical
Conflict of interest statement
No funding was obtained for the trial.
All authors declare that they have no financial or personal relationships with other people or organizations that could inappropriately influence (bias) their work.
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Radiosensitization by Hyperthermia Critically Depends on the Time Interval
2024, International Journal of Radiation Oncology Biology PhysicsHeat shock increases levels of reactive oxygen species, autophagy and apoptosis
2021, Biochimica et Biophysica Acta - Molecular Cell ResearchCitation Excerpt :Temperatures in the range of 40 to 44 °C are applied to a localized area of the body that has been invaded by a tumor [2]. Hyperthermia sensitizes cells to radiation and anticancer drugs, thus increasing their therapeutic efficacies without enhancing normal tissue morbidities [1–7]. Heat can eliminate drug-resistant tumor cells and is by far, the best radiosensitizer known [2,8,9].
In Regard to Datta et al.
2021, International Journal of Radiation Oncology Biology PhysicsMolecular and biological rationale of hyperthermia as radio- and chemosensitizer
2020, Advanced Drug Delivery ReviewsCitation Excerpt :Datta et al. demonstrated in a systematic review with conventional and network meta-analysis that in locally advanced cervical cancer thermoradiotherapy, thermochemoradiotherapy, and chemoradiation (3-weekly cisplatin) are the strategies achieving best clinical results for long-term locoregional tumour control, overall survival as well as acceptable side effects [68]. Lutgens et al. found similar effectiveness of thermoradiotherapy compared to the standard chemoradiation treatment of locally advanced cervical cancer in a prematurely closed randomized trial [81]. All mechanisms discussed in 2.1 and 2.2 are shown in Fig. 2.
Radiobiology: Foundation and New Insights in Modeling Brachytherapy Effects
2020, Seminars in Radiation OncologyCitation Excerpt :Radiosensitizing effects are maximum when radiation and HT are delivered simultaneously or within several minutes of one another.123 Clinical efficacy and safety of locoregional HT adjuvant to EBRT has been shown in large prospective randomized trials, notably in patients with pelvic malignancies.124,125 Few studies have been performed examining clinical applications of BT with concurrent HT.