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Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701)

Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701) - Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000819
Enrollment
360
Registered
2007-09-05
Start date
2007-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T1-2N0M0 glottic cancer

Interventions

A: Conventional fractionation radiation therapy (2 Gy/fr
T1:66 Gy/33 fr, T2:70 Gy/35 fr) B: Accelerated fractionation radiation therapy (2.4 Gy/fr
T1: 60 Gy/25 fr, T2: 64.8 Gy/27 fr)

Sponsors

Japan Clinical Oncology Group(JCOG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Primary tumor site is vocal cord. 2) Histologically proven squamous cell carcinoma. 3) Extent of primary tumor is evaluated as T1 or T2 without impaired cord morbidity. 4) Clinical N0/M0. 5) Planned radiation therapy fulfill limitation of overall treatment time. 6) Aged 20 to 80 years old. 7) Performance status of 0 or 1. 8) No prior surgery or radiation therapy against larynx. 9) No prior chemotherapy against any malignancies. 10) Sufficient organ functions. 11) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Active bacterial or fungous infection. 2) Simultaneous or metachronous (within 5 years) double cancers. 3) Women during pregnancy or breast-feeding. 4) Psychosis. 5) Systemic steroids medication. 6) History of collagen disease except for rheumatism. 7) Uncontrollable diabetes mellitus or administration of insulin. 8) Hemodialysis medication 9) Uncontrollable hypertension. 10) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.

Design outcomes

Primary

MeasureTime frame
3-year progression-free survival

Secondary

MeasureTime frame
overall survival, local progression-free survival, disease-free survival, survival with preserved voice function, complete response rate, proportion of treatment completion in specific term, adverse events

Countries

Japan

Contacts

Public ContactNaoto Shikama

JCOG0701 Coordinating Office Saku Central Hospital

JCOG_sir@ml.jcog.jp0267-82-3131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026