Health TrialsbyHealthPanel

Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

ConditionSeminoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorTata Memorial Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological diagnosis of classical seminoma

Primary site - testis, mediastinum or retroperitoneum

Stage IIB-IIIC (AJCC 8th edition)

Age>18 years

Disqualifiers

Histology other than classical seminoma

Non completion of planned first-line chemotherapy

Prior history of radiotherapy to the involved region

Inability to deliver adequate radiotherapy dose safely based on assessment by radiation oncologist

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiotherapy

    Radiation

    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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: RadiotherapyExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Centre

Lead sponsor

Source ClinicalTrials.gov
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