Extramammary Paget's disease
Conditions
Interventions
Arm A: Surgery alone
Arm B: Postoperative radiotherapy
Sponsors
OGATA Dai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed extramammary Paget's disease following surgical resection. (2) The preoperative primary tumor partially or completely involved the genital or perianal region. (3) One of the following lymph node dissections (LND) must have been performed. (i) For patients without radiologic lymph node enlargement and with positive sentinel lymph node biopsy: ipsilateral inguinal LND without prophylactic pelvic LND. (ii) For patients with radiologic lymph node enlargement confined to the inguinal region: ipsilateral inguinal LND without prophylactic pelvic LND. (iii) For patients with radiologic lymph node enlargement involving both the inguinal and pelvic regions: ipsilateral inguinal and pelvic LND. (4) Clinical complete resection of the primary tumor has been achieved. (5) Histologically confirmed R0 resection of the primary tumor. R1 resection is permitted only when the mucosal-side horizontal margin is positive with intraepithelial tumor. (6) Clinical complete resection of the regional lymph node metastases has been achieved. (7) Histologically confirmed regional lymph node metastases fulfill all the following: (i) At least two lymph node metastases on the ipsilateral side. (ii) No more than one lymph node metastasis on the contralateral side. (8) No distant metastasis on physical examination and contrast-enhanced CT. (9) Age >= 18 years on the day of the registration. (10) ECOG performance status of 0 or 1. (11) Within 63 days after surgery. (12) Judged eligible for postoperative radiotherapy by a radiation oncologist. (13) No prior radiotherapy to the inguinal or pelvic regions. (14) Sufficient organ function within 14 days before registration: (i) White blood cell count >= 3,000/mm3 (ii) Hemoglobin level >= 8.0 g/dL (iii) Platelet count >= 100,000/mm3 (iv) Total bilirubin <= 2.0 mg/dL (v) AST <= 100 IU/L (vi) ALT <= 100 IU/L (vii) Serum creatinine <= 1.3 mg/dL (15) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Synchronous or metachronous (within 5 years) malignancy, except intramucosal tumors curatively treated with local therapy. (2) Active infectious disease requiring systemic treatment at the time of registration. (3) Body temperature >= 38 degrees Celsius at the time of the registration. (4) Women who are planning pregnancy, pregnant, within 28 days postpartum, or breastfeeding, and men planning pregnancy with their partners. (5) Psychiatric disorders or symptoms that impair daily life and interfere with participation in the study (6) Continuous systemic administration (oral or intravenous) of steroids (>10 mg/day of prednisone equivalent) or other immunosuppressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, distant metastasis-free survival, incidence of adverse events, incidence of severe adverse events, patient-reported outcomes | — |
Contacts
Public ContactDai OGATA
Miyazaki University Hospital
Outcome results
None listed