Effect of COX-2 and EGFR Suppression on Molecular Markers of Angiogenesis and Proliferation in Squamous Cell Carcinoma of Oral Cavity - Prospective Randomized Study

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2022
• Main ID: NCT02748707
• Date of registration: 20/04/2016
• Prospective Registration: No
• Primary sponsor: Tata Memorial Hospital
• Public title: Effect of COX-2 and EGFR Suppression on Molecular Markers of Angiogenesis and Proliferation in Squamous Cell Carcinoma of Oral Cavity - Prospective Randomized Study ERLO-XIB
• Scientific title: Effect of COX-2 (Cyclooxygenase-2) and EGFR (Epidermal Growth Factor Receptor) Suppression on Molecular Markers of Angiogenesis and Proliferation in Squamous Cell Carcinoma of Oral Cavity - Prospective Randomized Study.
• Date of first enrolment: August 18, 2015
• Target sample size: 64
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02748707
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Sudhir V Nair, MBBS, MS,MCh
• Affiliation: Tata Memorial Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. All patients with squamous cell carcinoma of oral cavity (T2-T4, N1-2, M0) and are
candidates for first line curative surgical treatment and are able to swallow orally,
preoperatively.

2. Patients must be at least 18 years of age.

3. All patients must sign an informed consent before enrolling in study.

4. Patients must be able and willing to return to the clinic at appropriately scheduled
intervals.

5. No use of systemic steroids or topical oral steroid preparations within three months.
(Topical nasal steroid sprays or cutaneous preparations with minimal systemic
absorption for nasal or dermatologic disorders are allowed).

6. Premenopausal women must be using adequate birth control methods and have a negative
pregnancy test prior to entry.

7. Karnofsky Performance Score above 80.

8. The subject is willing and able to fully participate for the duration of the study.

9. If applicable, the subject has been counseled on smoking cessation.

10. The subject meets the following laboratory eligibility criteria during a time not to
exceed 4 weeks prior to randomization.

11. Hemoglobin level above 10gm/dl, the lower limit of normal.

12. WBC count > 3,000 mm3.

13. Platelets count > 100,000 m3.

14. Total bilirubin, AST (Aspartate Aminotransferase) and ALT (Alanine transaminase) = 2 x
ULN.

15. Serum creatinine = 2 x Upper limit of Normal (ULN)

Exclusion Criteria:

1. History of cardiovascular co morbidities 2. Patients with previous history of head and
neck cancers 3. Recent massive gastrointestinal hemorrhage 4. An on-going unmanaged serious
infectious disease or major metabolic disorder 5. Neutrophil count of <1 x 109 per liter or
platelet count of < 75 x 109 per liter at study entry, 6. Bilirubin at >1.5-fold above the
upper limit of normal, and 7. Kidney failure (Glomerular filtration rate of <40 mL/min). 8.
Pregnant women 9. Use other nonsteroidal anti-inflammatory drugs (NSAIDs) or
corticosteroids within 2 weeks prior to initial clinical evaluation 10. The subject is, in
the opinion of the Institutional Principal Investigator, not an appropriate candidate for
study participation.

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Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma of Buccal Mucosa

Tongue Cancers

Head and Neck Cancers

Oral Squamous Cell Carcinoma

Intervention(s)

Drug: Arm 3

Drug: Arm1

Other: Arm 4

Drug: Arm 2

Primary Outcome(s)

Change in expression of selected biomarkers in tissue samples, assessed by immunohistochemistry (IHC) and PCR [Time Frame: baseline and 21 days]

Secondary Outcome(s)

Clinical and radiological Change in tumor size and appearance [Time Frame: baseline and 21 days]

Secondary ID(s)

830

Source(s) of Monetary Support

Please refer to primary and secondary sponsors