To study chances of second cancer.

Phase 2

Completed

• Conditions: Health Condition 1: null- Patients who have been treated with radical non-surgical techniques

• Registration Number: CTRI/2017/11/010322
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-01-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 656

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

NA

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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