To study chances of second cancer.

A Cross sectional study to estimate the Incidenceof Second primary Cancers in patients with locally advanced non-nasopharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC) treated with radical, non-surgical methods

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/11/010322

Enrollment

500

Registered

2017-11-01

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 who have been treated with radical non-surgical techniques

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Only those patients who have completed planned protocol treatment Have complete follow-up information till last event or death, whichever was later After IRB approval all data will be collected according to the case record form (CRF) All patients will be deemed as having a second primary if they satisfy the following criteria [Warren & Gates, NCI (2006) & Hong]: 1. Both neoplasms must be malignant, confirmed by histopathology, and in a different location from the index cancer. 2. The two neoplasms must be anatomically separated by normal non neoplastic mucosa. If the lining mucosa demonstrates dysplasia, it is considered a multicentric primary neoplasm. 3. A second primary tumor that developed at the same site as an index tumor but occurred more than 3 years later will also be considered a second primary tumor. 4. To exclude the possibility that the secondarily-developed primary tumor represents a metastasis or local recurrence, it must be separated from the first tumor by at least 2 cm of normal epithelium, or it would occur at least 3 years after the first diagnosis. 5. The SPM will be considered â??â??metachronousâ??â?? if it developed more than 6 months after an index cancer diagnosis.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
To study incidence and trend of second primary with respect to the site of primary, stage of primary, and time after diagnosis and treatment of the index cancer.Timepoint: after diagnosis and treatment of the index cancer.	—

Secondary

Measure	Time frame
2. To study the outcomes: Locoregional control, disease free survival and overall survival rates in patients with second primary in HNSCC.Timepoint: After completion of primary treatment	—

Countries

India

Contacts

Public ContactDrSarbani Ghosh Laskar

Tata Memorial Hospital

sarbanilaskar@yahoo.co.in02224177000

Outcome results