CALLA

Phase 3

Completed

• Conditions: ocally Advanced Cervical Cancer

• Registration Number: JPRN-jRCT2080224829
• Lead Sponsor: AstraZeneca KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

1. Female

2. Aged at least 18 years

3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node

4. No prior chemotherapy or radiotherapy for cervical cancer

5. WHO/ECOG performance status of 0-1

6. At least 1 lesion, not previously irradiated, that q
ualifies as a RECIST 1.1 Target Lesion at baseline

Exclusion Criteria

1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer

2. Intent to administer a fertility-sparing treatment regimen

3. Undergone a previous hysterectomy

4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes 15 mm (short axis) or more above the L1 cephalad body in the inguinal region or outside the planned radiation field

5. History of allogeneic organ transplantati

6. Active or prior documented autoimmune or inflammatory disorders

7. Uncontrolled intercurrent illness

8.History of another primary malignancy and active primary immunodeficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified