Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorTata Memorial Hospital

About this trial

The vaginal cancers are responsible for 2% of gynecological cancer while vulvar cancers account for 4 % of gynecological cancers. HPV 16 and 33 are most prevalent in vaginal cancers and account for more than half of cases HPV related vaginal cancer. However, adeqaute information is not there. Similarly, structured QOL data is not available for India. Therefore, in the proposed study we will like to systematically evaluate the patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy). The therapeutic research in vulvo-vaginal cancers has been relatively slow and such structured registration databases can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30 and VU-34) in rare cancers. We hope that we will get help in identifying thrust areas for future research including prospective interventional trials through this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients diagnosed with vulvo- vaginal cancer.

Patients treated with Radiation+/- chemotherapy+/-surgery from January 1, 2019- December 31, 2023.

Disqualifiers

Patients with Metastatic disease at the presentation.

Incomplete information on the EMR.

Trial population

The study population will include patients who have completed radiation treatment for vulvo-vaginal cancer, and who are undergoing radiation treatment for vulvo-vaginal cancer.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Cohort A
Group B: Cohort B

Trial outcomes

Primary outcomes

1

To report patterns of relapse in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)

To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting

Time frame
5 years
2

To report patterns of disease outcome in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)

To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting

Time frame
5 Years

Secondary outcomes

1

To report outcomes as a function of p16, AKT, PDL-1 expression.

IHC Staining will be performed for p16, AKT, PDL-1 expression

Time frame
5 years
2

To report on acute and late effect of treatment outcomes using CTCAE.

Time frame
5 years
3

To report on longitudinal QOL using EORTC QLQ C-30 (English, Hindi, Marathi as applicable)

Time frame
5 years
4

To report on longitudinal QOL using EORTC VU-34 (English, Hindi, Marathi as applicable)

Time frame
5 Years

Other outcomes

Sponsors and contacts

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