A Phase 3 Study of Active Surveillance for Low Risk Germ Cell Tumour (Tumour of Cells of Reproductive System) and at the same time study to compare the use of Carboplatin versus Cisplatin (chemotherapetic agents) for Standard Risk children and adult patients with Germ Cell Tumors

Phase 3

• Conditions: Health Condition 1: C51-C58- Malignant neoplasms of female genital organsHealth Condition 2: C60-C63- Malignant neoplasms of male genital organs

• Registration Number: CTRI/2021/12/038584
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

(all should be met)

1. Age

1.1 Low Risk Stratum (Stage I Ovarian Immature Teratoma and Stage I Malignant GCT (all sites))

Patients must be <=15 years of age at enrollment.

1.2 Standard Risk 1

Patients must be < 11 years of age at enrollment.

1.3 Standard Risk 2

Patients must be >= 11 and <=15 years of age at enrollment.

2. Newly diagnosed patients with extracranial germ cell tumors with diagnosis based on biopsy/post surgical

specimen histology

3. Good performance status

4. Adequate organ function as defined below (only for chemotherapy arm -Standard risk 1 and 2)

4.1 Adequate renal function defined as Creatinine clearance or radioisotope GFR ï?³ 70 mL/min/1.73 m2 or a

serum creatinine threshold level which is defined based on age/gender (supplied in the protocol)

4.2 Adequate liver function defined as total bilirubin which is 1.5 x upper limit of normal (ULN) for age, and

SGOT (AST) or SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age

4.3 Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise intolerance, and a

pulse oximetry > 94% if there is clinical indication for determination.

5. Informed consent given.

6. No prior systemic chemotherapy.

7. Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain

metastases. [This exception only applies to SR1 patients]

Exclusion Criteria

(if any one present)

1. Stage I testicular GCT patients who have undergone RPLND (Retroperitoneal Lymph node dissection) or

Pure dysgerminoma or pure seminoma or Pure mature teratoma or Pure Immature teratoma COG Stage I,

Grade I or Pure Immature teratoma COG Stage I, Grade 2 and 3 with Serum AFP level >= 1000ng/ml

2. Pure immature teratoma COG Stage II - IV or â??Poor riskâ?? 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

tumor.

3. Patients with standard risk GCT with significant respiratory compromise due to either abdominal tumor

limiting diaphragmatic excursion or pulmonary metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified