Selective radiation dose escalation for advanced head and neck cancer treatment
Phase III A Prospective, Randomized, Rater-blinded, Multicentre Interventional Clinical Trial. Do Selective Radiation Dose Escalation and Tumour Hypoxia Status Impact the Locoregional Tumour Control After Radiochemotherapy of Head & Neck Tumours?
PHASE3 · Technical University of Munich · NCT01212354
This study is testing whether giving a higher dose of targeted radiation along with chemotherapy can help people with advanced head and neck cancer do better than with standard radiation doses.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Technical University of Munich (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT01212354 on ClinicalTrials.gov |
What this trial studies
This phase III randomized trial investigates the effects of dose escalated Intensity Modulated Radiotherapy (IMRT) combined with Cisplatin chemotherapy on locally advanced head and neck cancer. The study compares two treatment arms: one receiving a higher radiation dose to the primary tumor and involved lymph nodes, and the other receiving standard radiation doses. The trial aims to improve loco-regional control of the cancer by targeting hypoxic tumor areas, which are known to be more resistant to treatment. Patients will be stratified based on tumor hypoxia status using PET imaging to assess the significance of the treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with irresectable squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
Not a fit: Patients with resectable tumors or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cancer control and survival rates for patients with locally advanced head and neck cancer.
How similar studies have performed: Other studies have shown promising results with similar dose escalation strategies in radiation therapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed written informed consent * Age ≥ 18 ≤ 70 years * Independent of gender * Independent of race * ECOG 0 - 2 * Tumor of oral cavity, oropharynx or hypopharynx * Histology: squamous cell carcinoma * Curative treatment intended * Tumor is classified as irresectable (see Appendix) * Woman of child-bearing age: negative pregnancy test in serum * Contraception in male and female patients and their partners if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post therapy * Sufficient bone marrow reserves during 7 days before study inclusion; (leukocytes ≥ 4 x 109/l, absolute no. of neutrophiles (ANC) ≥ 2 x 109/; thrombocyte count ≥ 100 x 109/l; Hemoglobin ≥ 10g/dl) * adequate liver function during 7 days before study inclusion (total bilirubine ≤ 2,5 x ULN (upper limit of normal), ASAT/ ALAT ≤ 2,5 x ULN, alkaline phosphatase ≤ 2,5 x ULN of the institution's normal value) * adequate kidney function during 7 days before study inclusion; serum creatinine ≤ 130 μmol/l; creatinine clearance ≥ 70 ml/min * all patients should have a dental examination before starting therapy and when necessary be treated, adaptation of a teeth protection bar * a percutane feeding tube should be applied before start of treatment Exclusion Criteria: * Infiltration of the mandible and / or larynx * impaired renal and/ or liver function * secondary malignancy, unknown primary cancer, nasopharynx cancer or salivary gland cancers * Metastatic disease * Another cancer within 5 years of study entry * Serious concomitant disease or medical condition * Pregnancy or lactation * Women of child-bearing potential with unclear contraception (post menopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) * previous treatment with chemotherapy, radiotherapy or surgery in head and neck (except an excisional biopsy or biopsy for histology) * concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening * life expectancy of \< 12 months * contraindications to receive Cisplatin * social situations that limit compliance with study requirements
Where this trial is running
Munich, Bavaria
- Klinik für RadioOnkologie Strahlentherapie — Munich, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Steffi U. Pigorsch, Dr. med. — Klinik für Strahlentherapie und Radiologische Onkologie, Klinikum rechts der Isar der TU München Ismaningerstr. 22; 81675 Munich, Germany
- Study coordinator: Sabine Barta, Dr.
- Email: sabine.barta@mri.tum.de
- Phone: +49 (0)89-4140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Head and Neck Cancer, intensity modulated radiotherapy, selective dose escalation, hypoxia, head cancer, neck cancer