Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

Tata Memorial Centre74 enrolled

Overview

Testicular tumors account for 1% of all cancers in males and germ cell tumors comprise 95% of all testicular cancers. Seminomas consist of around 50% of cases. However,adequate information is not there as 60- 80% residual disease is seen even after with the standard management of chemotherapy. With the advent of functional imaging there was hope that it could aid in more accurately targeting these tumors to systematically evaluate the role of PET-CT imaging in identifying patients diagnosed with stage IIB-IIIC seminomatous germ cell tumor, with residual visible tumor post chemotherapy who would benefit with loco regional radiotherapy. The therapeutic research in Seminomashas been relatively slow and such structured studies 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) in these cancers. We hope that we will get help in identifying thrust areas for future research through this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Seminoma

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histological diagnosis of classical seminoma 2. Primary site - testis, mediastinum or retroperitoneum 3. Stage IIB-IIIC (AJCC 8th edition) 4. Age\>18 years 5. Karnofsky Performance Status at least 70 6. A response assessment FDG PETCT scan done at least twelve weeks after the first line chemotherapy, showing a persistent measurable residual mass 7. Patient willing and reliable for follow up and QOL. Exclusion Criteria: 1. Histology other than classical seminoma 2. Non completion of planned first-line chemotherapy 3. Prior history of radiotherapy to the involved region 4. Inability to deliver adequate radiotherapy dose safely based on assessment by radiation oncologist

Outcomes

Primary Outcomes

Progression free survival(PFS)

• Progression free survival (PFS) is defined as the time period from the date of enrolment in the study till the first observation of disease progression at any site, or death.

Time frame: 2 years

Secondary Outcomes

Locoregional control (LRC)

• Locoregional control (LRC) defined as the time period from the date of enrolment in the study till the first observation of disease progression locally and/or in the regional lymph nodes, or death.

Time frame: 2 years

Overall survival (OS)

• Overall survival (OS) defined as the time period from the date of enrolment in the study till the date of death.

Time frame: 2 years

Second-line salvage therapy-free survival

• Second-line salvage therapy-free survival defined as the time period from the date of enrolment in the study till date of starting second-line chemotherapy.

Time frame: 2 years

Acute radiation toxicity

Incidence of Acute radiation toxicity will be defined as any toxicity within 90 days post RT using RTOG and CTCAE

Time frame: 2 years

Late radiation toxicity

Incidence of late radiation toxicity defined as any toxicity after 90 days of post RT using RTOG and CTCAE

Time frame: 2 years

Patient-reported quality of life (QOL)

Patient-reported quality of life (QOL) will be assessed using the EORTC QLQ-C30 questionnaire's validated translations in English, Hindi, and Marathi.

Time frame: 2 years

Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes