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Mitomycins

Mitomycin

Joyce Baard, MD, MSc

Orlane Figaroa, MD

The goal of this observational study is to evaluate the intravesical recurrence (IVR) rate after ureteroscopy (diagnostic or treatment) for upper tract urothelial carcinoma (UTUC) followed by an adjuvant single instillation of Mitomycin C (SI-MMC).

The main question it aims to answer are:

* What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC
* How is the IVR compared with a historical cohort (no SI-MMC)
* What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy (RNU)
* What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU

The primary objective is to evaluate the IVR rate after ureteroscopy (diagnostic or treatment) followed by an single instillation of MMC (SI-MMC), in patients with clinically non-metastatic UTUC.

The main question we aim to answer are:

* What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC
* How is the IVR compared with a historical cohort (no SI-MMC)
* What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy
* What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU.

Secondary objectives include the evaluation of possible predictive factors for IVR rate.

Study design: Multicentre, prospective cohort study in a clinical setting,

Study population: All adult patients (age ≥18 years) with a (suspicion of a) urothelial carcinoma of the upper urinary tract undergoing ureteroscopy, either diagnostic or as endoscopic kidney sparing treatment, followed by a post-operative single instillation of Mitomycin C.

Intervention: No intervention

Main study parameters/endpoints:

The primary endpoint of this study is the time to and total intravesical recurrences (histological proven) in the first 24 months following ureteroscopy (diagnostic or treatment) for UTUC followed a single instillation of Mitomycin C.

Secondary Objective(s): to evaluate possible predictive factors for IVR rate looking at gender, tumour size, tumour focality, tumour location, postoperative stent placement, use of an ureteral access sheath, timing of administration of MMC, the performance of an endoscopic biopsy during ureteroscopy.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Investigations during follow-up include cystoscopy, ureteroscopy and CT-urography, which is in line with the standardized care and will not include additional investigations.

Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC

Effect of a Single Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: A Prospective, Multicenter Study

What is the time to and total number of IVR 2 years after ureteroscopy (diagnostic or treatment) with SI-MMC for UTUC

What is the time to and total number of IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy

Is there an additional value of SI-MMC on total and time to IVR after RNU in patients who were evaluated by ureteroscopy prior to RNU. Outcome measurement (time to IVR and total IVR) will be compared to a historical cohort who did not receive Mitomycin C to evaluate the additional effect

to evaluate possible predictive factors for IVR rate looking different variables by multivariate logistic regression; with the dependent variable IVR and independent variables: gender (male/ female), tumour size (\< 2cm/ \>2cm), tumour focality (unifocal/ multifocal), tumour invasiveness (invasive/ non-invasive), tumour location (ureter/ puelocaliceal), use of Urethral access sheath (yes/no), use of postoperative stent (yes/ no), timing of MMC administartion (\<24h/\>24h)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

drs J. Baard Urologist (PI)

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Stomach Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Sarcoma

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Melanoma

Carcinoma, Renal Cell

Head and Neck Neoplasms

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Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Kidney Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Soft Tissue Sarcoma

Renal Cell Carcinoma

Small Intestine Cancer

Gemcitabine

Doxorubicin

Liposomal doxorubicin

Immunomodulating Agents

Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).

Systemic therapy will be pre-specified based on the standard of care approach for that patient, and it may include cytotoxic, targeted, hormonal, or immunotherapy.

The experimental arm consists of SBRT (and standard of care systemic therapy). Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.

Patients treated with prior or concomitant systemic therapy are eligible for this study. Use of chemotherapy regimens, targeted therapy or immunotherapy containing potent enhancers of radiation damage (e.g. gemcitabine, doxorubicin) can be postponed or interrupted for a duration of one month after radiation.

Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.

Stereotactic body radiotherapy

Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).

Palliative RT

EORTC HQ

Robbie Van den Begin, MD

Pieter Deseyne, MD

Piet Ost, MD

David Pasquier, MD

Antonin Levy, MD

Daniela Alterio, MD

Hossein Hemmatazad, MD

Matthias Guckenberger, MD

Jennifer Sherriff, MD

Shane Zaidi, MD

Matthias Guckenberger

Piet Ost

This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.

Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.

The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.

Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.

Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events:

* Development new metastatic lesions,
* Cancer-related death.

Time to development of polymetastatic disease is the time interval from the date of randomization to the date of first occurrence of any of the following events:

* Presence of more than 5 metastases at a specific timepoint during follow-up,
* Development of metastases that preclude treatment with SBRT (e.g. due to large size or locating in previously irradiated region where re-irradiation is not possible),
* Cancer-related death.

Anticancer Fund, Belgium

Rising Tide Foundation

European Organisation for Research and Treatment of Cancer - EORTC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC	NCT05731622	Upper Urinary T...		18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)	NCT04498767	Gynecologic Can... Skin Cancer Head and Neck C... Sarcoma Renal Cancer Bladder Cancer Upper Urinary T... Pancreatic Canc... Hepatobiliary C... Gastric Cancer Small Bowel Can... Esophageal Canc... Melanoma Colon Cancer Oligometastasis	Stereotactic bo... Palliative RT	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC	NCT05731622	Upper Urinary T...		18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for upper urinary tract carcinoma