Escalating radiation doses for head and neck cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial, DE-HyART, investigates the effects of increasing radiation doses specifically targeting hypoxic areas in head and neck squamous cell carcinoma (HNSCC). The study employs intensity-modulated radiation therapy (IMRT) combined with concurrent chemotherapy using cisplatin. Patients will undergo a baseline scan to determine hypoxia levels, and those with hypoxic tumors will be randomized into two treatment arms, one receiving standard treatment and the other receiving an escalated radiation dose. The primary goal is to assess locoregional control and the feasibility of this approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18 - 70 years
* Willingness to sign informed consent (written/video documentation)
* Performance status: ECOG 0 - 2
* Histology proved - squamous cell carcinoma
* Any grade, gender
* Tumour sites: Oral Cavity, Oropharynx, Hypopharynx and Larynx
* Sufficient bone marrow reserve within the last 14 days.

  * Hb: \> 10g/dl (corrected)
  * TLC: \> 4,000 per cumm
  * Platelet: \>1.5Lakh per cumm
* Liver functions and kidney functions within normal limits
* Nutritional and dental assessment before inclusion into the study

Exclusion Criteria:

* HPV (p16) positive tumours
* Prior surgery and/or radiation therapy given for any HNC
* T1/T2 Glottis
* Metastatic disease or disease not amenable for definitive locoregional treatment.
* Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin)
* Pregnancy or lactation

Where it's running

• Rajiv Gandhi Cancer Institute and Research Centre
  Delhi, India Recruiting

Study contacts

• Principal investigator: Munish Gairola, MD,DNB Radiation Oncology — Rajiv Gandhi Cancer Institute and Research Centre
• Study coordinator: Sarthak Tandon, DNB
• Email: tandon.sarthak@rgcirc.org
• Phone: +911147022009

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

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• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.