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Observational study for patients with locally advanced head and neck carcinoma receiving definitive or adjuvant chemoradiation, outside of a clinical trial.

OBSERVATIONAL STUDY TO EVALUATE THE OUTCOME OF PRESCREEN FAILURE AND SCREEN FAILURE PATIENTS WHO RECEIVE CHEMORADIATON FOR LOCALLY ADVANCED HEAD AND NECK CANCER

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/08/004906
Enrollment
1500
Registered
2014-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with locally advanced squamous cell or undifferentiated carcinoma of the head and neck region

Interventions

None listed

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological or cytological proven diagnosis of squamous cell or undifferentiated carcinoma of the head and neck region or squamous cell carcinoma of the head and neck region of unknown primary. 2. Planned for or has received curative intent concurrent chemoradiotherapy, either in the definitive or adjuvant setting. 3. Prescreen failure or screen failure of trial no 838/ 937

Exclusion criteria

Exclusion criteria: 1. Recruited on either of below mentioned protocol: i) Phase III non-inferiority randomized trial comparing three-weekly Cisplatin versus weekly Cisplatin in combination with radiation therapy in patients with advanced carcinoma of the head and neck( TMH NO-937) ii) â??An Open label, Randomized, Investigator Initiated Multicentric, Phase III Study of Nimotuzumab in combination with Concurrent Radiotherapy and Cisplatin versus Radiotherapy and Cisplatin alone, in Subjects with Locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)â?? (TMH NO: 838)

Design outcomes

Primary

MeasureTime frame
Reasons for prescreen and screen failure Locoregional control Secondary: Response rate( where applicable) Toxicity, Compliance to treatment, Disease free survival Progression-free survival, Overall survival, Quality of life The type and frequency of tests, admissions, outpatient visits, etc, will be standard and not part of the study. The above parameters will be recorded as part of our observational study Timepoint: 6-8 weeks after completion of CTRT, to assess response. Then every 3 months, and when there is clinical evidence of progression.—

Secondary

MeasureTime frame
Response rate( where applicable) Toxicity, Compliance to treatment, Disease free survival Progression-free survival, Overall survival, Quality of life The type and frequency of tests, admissions, outpatient visits, etc, will be standard and not part of the study. The above parameters will be recorded as part of our observational study Timepoint: Start of CTRT, weekly during therapy, at completion of CTRT, then every 3 months for 2 years.—

Countries

India

Contacts

Public ContactDr Vanita Noronha

Tata Memorial Hospital

vanita.noronha@gmail.com9769328047

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026