A study looking at active surveillance in low risk disease and comparing two treatment strategies for standard risk germ cell tumours in children and adults

Phase 1

• Conditions: Ovarian, Testicular, or Extragonadal germ cell tumours; MedDRA version: 21.0Level: PTClassification code 10015800Term: Extragonadal primary germ cell tumour mixed stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10015801Term: Extragonadal primary germ cell tumour mixed stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10015802Term: Extragonadal primary germ cell tumour mixed stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10043331Term: Testicular germ cell tumour mixed stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10043332Term: Testicular germ cell tumour mixed stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10043333Term: Testicular germ cell tumour mixed stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10004433Term: Benign ovarian tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10006032Term: Borderline ovarian tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004141-17-GB
• Lead Sponsor: Children's Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-07
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1680

Inclusion Criteria

1. Histologic verification of a primary extracranial germ cell tumour (GCT) as outlined in any of the categories outline in the protocol.
2. Performance status corresponding to ECOG scores of 0, 1, 2 or 3. (Use Karnofsky for patients > 16 years of age and Lansky for patients = 16 years of age).
3. For the low Risk Stratum patients must be < 50 years of age at enrolment.
4. For Standard Risk 1 patients must be < 11 years of age at enrolment.
5. For Standard Risk 2 patients must be = 11 and < 25 years of age at enrolment.
6. For patients receiving chemotherapy (SR1 and SR2):
a) Patients must have adequate renal function defined as; creatinine clearance or radioisotope GFR =70 mL/min/1.73 m2 or a serum creatinine based on age/gender as defined in the protocol.
b) Patients must have adequate liver function defined as total bilirubin < or = 1.5 x upper limit of normal (ULN) for age, and – AST or ALT < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for ALT is 45 U/L).
c) Patients must have adequate pulmonary function defined as no evidence of dyspnoea at rest, no exercise intolerance, and a pulse oximetry > 94%. Pulmonary Function Tests are not required.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1390
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 392
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Patients with any diagnoses not listed in the inclusion criteria of the protocol including: Pure dysgerminoma and pure seminoma, Pure mature teratoma, Pure immature teratoma COG Stage II - IV or FIGO Stage IC to IV, Poor risk” GCT (age = 11 years old and COG Stage IV ovarian, COG Stage III or IV EG, or IGCCC intermediate or poor risk testicular, or Primary CNS germ cell tumour).
2. Elevation of serum tumour markers without histologic confirmation.
3. Had no prior systemic therapy.
4. Had no prior radiation therapy except for CNS irradiation of brain metastases.
5. Patients with significant respiratory compromise due to either abdominal tumour limiting diaphragmatic excursion or pulmonary metastases.
6. Pregnancy and Breast Feeding - These criteria apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients):
a) Female patients who are pregnant.
b) Lactating females who plan to breastfeed their infants.
c) Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified