Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: Randomized controlled double blind clinical trial

Sheetal D. Ullal, K. K. Shenoy, M. R S M Pai, M. N. Chowta, S. M N Adiga, M. Dinesh, A. Kamath, M. S. Kotian, D. K. Pai

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. Aim: To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n=23) received normal saline infusion, group 2 (test; n=23) received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65%) patients had complete response, five (22%) partial/no response, two (9%) died, one (4%) lost to follow up. In the control, five (22%) patients had complete response, 16 (70%) partial/no response, one (4%) died, one (4%) lost to follow up. Short-term loco-regional response was better in the test (DF=3 , 95% Confidence Interval 0.418, 0.452, P=0.0048). In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

Original languageEnglish
Pages (from-to)151-155
Number of pages5
JournalIndian Journal of Cancer
Volume43
Issue number4
Publication statusPublished - 01-10-2006

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Oropharyngeal Neoplasms
Clinical Trials
Safety
Radiotherapy
Lost to Follow-Up
Vomiting
India
Dysgeusia
Neoplasms
Mucositis
Oropharynx
Deglutition Disorders
Nonparametric Statistics
Intravenous Infusions
Squamous Cell Carcinoma
Therapeutics
Biomarkers
Placebos
Research Personnel
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Medicine(all)
  • Cancer Research
  • Oncology

Cite this

@article{731ef1db72b5446c90638bbf36baed57,
title = "Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: Randomized controlled double blind clinical trial",
abstract = "Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. Aim: To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n=23) received normal saline infusion, group 2 (test; n=23) received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65{\%}) patients had complete response, five (22{\%}) partial/no response, two (9{\%}) died, one (4{\%}) lost to follow up. In the control, five (22{\%}) patients had complete response, 16 (70{\%}) partial/no response, one (4{\%}) died, one (4{\%}) lost to follow up. Short-term loco-regional response was better in the test (DF=3 , 95{\%} Confidence Interval 0.418, 0.452, P=0.0048). In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.",
author = "Ullal, {Sheetal D.} and Shenoy, {K. K.} and Pai, {M. R S M} and Chowta, {M. N.} and Adiga, {S. M N} and M. Dinesh and A. Kamath and Kotian, {M. S.} and Pai, {D. K.}",
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Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers : Randomized controlled double blind clinical trial. / Ullal, Sheetal D.; Shenoy, K. K.; Pai, M. R S M; Chowta, M. N.; Adiga, S. M N; Dinesh, M.; Kamath, A.; Kotian, M. S.; Pai, D. K.

In: Indian Journal of Cancer, Vol. 43, No. 4, 01.10.2006, p. 151-155.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers

T2 - Randomized controlled double blind clinical trial

AU - Ullal, Sheetal D.

AU - Shenoy, K. K.

AU - Pai, M. R S M

AU - Chowta, M. N.

AU - Adiga, S. M N

AU - Dinesh, M.

AU - Kamath, A.

AU - Kotian, M. S.

AU - Pai, D. K.

PY - 2006/10/1

Y1 - 2006/10/1

N2 - Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. Aim: To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n=23) received normal saline infusion, group 2 (test; n=23) received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65%) patients had complete response, five (22%) partial/no response, two (9%) died, one (4%) lost to follow up. In the control, five (22%) patients had complete response, 16 (70%) partial/no response, one (4%) died, one (4%) lost to follow up. Short-term loco-regional response was better in the test (DF=3 , 95% Confidence Interval 0.418, 0.452, P=0.0048). In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

AB - Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. Aim: To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n=23) received normal saline infusion, group 2 (test; n=23) received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65%) patients had complete response, five (22%) partial/no response, two (9%) died, one (4%) lost to follow up. In the control, five (22%) patients had complete response, 16 (70%) partial/no response, one (4%) died, one (4%) lost to follow up. Short-term loco-regional response was better in the test (DF=3 , 95% Confidence Interval 0.418, 0.452, P=0.0048). In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

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