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NCT02201355
Hypofractionated Reduced-Volume Chemoradiation for T1/2N0-2 SCC Head and Neck
Phase 1 trial testing Intensity Modulated Radiotherapy in Squamous Cell Carcinoma of the Head and Neck T1/2N0-2 in 8 participants. Terminated before completion.
23 January 2018
Quick facts
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 18 September 2014 |
| Primary completion | 23 January 2018 |
| Estimated completion | 15 May 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Intensity Modulated Radiotherapy
Conditions studied
- Squamous Cell Carcinoma of the Head and Neck T1/2N0-2 — all drugs for Squamous Cell Carcinoma of the Head and Neck T1/2N0-2 →
Sponsor
University of Texas Southwestern Medical Center
Who can join
Adults 18 to 99, any sex, with Squamous Cell Carcinoma of the Head and Neck T1/2N0-2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objectives: To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx, hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks using reduced volume IMRT Secondary Objectives: To describe the adverse events associated with hypofractionated, reduced volume cisplatin chemoradiation. To estimate response rates and progression-free survival rates of hypofractionated, reduced volume cisplatin chemoradiation. To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation. If patients can safely be treated in three weeks rather than six weeks, such a schedule would provide a much more convenient alternative for patients and result in a significant reduction in the health care resources currently expended on cure of these patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02201355
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02201355 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
- Last refreshed: 2 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02201355.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing