Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

Seminoma Clinical Trial

Official title:

FDG PET-CT Based Risk Adapted Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: A Prospective Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05142982
• Other study ID #: PROsem
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: December 15, 2029

Study information

• Verified date: December 2021
• Source: Tata Memorial Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: December 15, 2029
• Est. primary completion date: December 15, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Seminoma

Intervention

Radiation:
• Radiotherapy
A dose of 30-36 Gy in conventional fractionation of 1.8-2.0 Gy per fraction using 3-dimensional conformal technique. Radiotherapy will be delivered five days a week.

Locations

Country	Name	City	State
India	Tata Memorial Centre	Mumbai	Maharashtra
India	Dr Vedang Murthy	Navi-Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years
Secondary	Overall survival (OS)	• Overall survival (OS) defined as the time period from the date of enrolment in the study till the date of death.	2 years
Secondary	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.	2 years
Secondary	Acute radiation toxicity	Incidence of Acute radiation toxicity will be defined as any toxicity within 90 days post RT using RTOG and CTCAE	2 years
Secondary	Late radiation toxicity	Incidence of late radiation toxicity defined as any toxicity after 90 days of post RT using RTOG and CTCAE	2 years
Secondary	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.	2 years