Overview

This trial is active, not recruiting.

Condition merkel cell carcinoma
Treatments carboplatin, etoposide, radiotherapy
Phase phase 2
Sponsor Trans-Tasman Radiation Oncology Group (TROG)
Start date December 2009
End date December 2020
Trial size 43 participants
Trial identifier NCT01013779, ACTRN12610000480088, TROG 09.03

Summary

A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will undergo PET scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.
carboplatin
During radiotherapy: Carboplatin (AUC2) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation). After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (AUC4.5) intravenously on day 1.
etoposide
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
radiotherapy RT
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions

Primary Outcomes

Measure
Time to loco-regional failure curve
time frame: Minimum of 18 months follow up
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
time frame: Duration of Radiotherapy treatment

Secondary Outcomes

Measure
Overall survival and time to distant failure curves
time frame: 3 year acturarial curves
Proportion of patients for which PET can influence management.
time frame: 12 weeks post Radiotherapy
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
time frame: 12 weeks post Radiotherapy
Post-treatment PET complete response rate for patients with unresected disease
time frame: 12 weeks post Radiotherapy

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria for Trial Registration: Patients may be registered on the trial only if they meet all of the following criteria: - Age 18 years or older - Written informed consent to participate in the study - Able to undergo 18-FDG PET scan (no uncontrolled diabetes mellitus or severe claustrophobia). - Available for follow-up. - Using adequate contraception if capable of child bearing - Any Merkel Cell carcinoma confined to the primary and/or nodal sites - ECOG 0-2. - Full Blood Count (FBC) should be satisfactory ( Haemoglobin > or equal to 10g/dl, neutrophils > or equal to 2.0 x 109 /l and platelets > or equal to 100 x 109 /l) and renal function (GFR > or equal to 50 ml/min) and hepatic function ( ALT < 5 X upper limit normal, bilirubin < 1.5 X upper limit normal) - Patients must be able to tolerate protocol treatment Exclusion Criteria for Registration: - Previous chemotherapy in the past 5 years or prior radiotherapy to the area of concern - Unable to comply with treatment protocol eg dementia - Other malignancy in the past 5 years other than non-melanoma skin cancer. - Women who are pregnant or lactating. - Clinical evidence of metastatic disease. - Immunosuppression from long term steroid use or immunosuppressive drugs. - Any serious illness or medical condition that precludes the safe administration of the chemotherapy including: 1. Active infection 2. Uncontrolled or unstable cardiac disease including unstable angina, myocardial infarction within the last 3 months, and recurrent ventricular arrhythmias Inclusion Criteria for Treatment Registration: Patients may proceed to protocol treatment if they meet the following criteria: - High risk disease with no evidence of distant spread: Biopsy proven MCC with a primary that is > 2cm (T2N0M0= Stage II) and/or regional nodes (any T, N1M0= Stage III); OR Recurrent MCC not previously treated with radiation treatment; Dermal or in-transit metastasis with or without nodes; Occult primary with involved nodes - Patients who have no metastases on CT or PET scan OR If CT is suggestive of metastases, they must be PET negative

Additional Information

Official title A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Trans-Tasman Radiation Oncology Group (TROG).